Pharmacy and Poisons Board: Applications

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- controllerapplications
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- pass(array)
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====

Sql Logs

default

Total Time: 51 ms
Total Queries: 53 queries

Query	Affected	Num. rows	Took (ms)	Actions
SELECT COUNT(*) AS `count` FROM `ctr`.`applications` AS `Application` WHERE `Application`.`id` = 125	1	1	0
SELECT `Application`.`id`, `Application`.`user_id`, `Application`.`application_id`, `Application`.`is_child`, `Application`.`trial_status_id`, `Application`.`total_sites`, `Application`.`abstract_of_study`, `Application`.`study_title`, `Application`.`laymans_summary`, `Application`.`short_title`, `Application`.`protocol_no`, `Application`.`reference_no`, `Application`.`version_no`, `Application`.`date_of_protocol`, `Application`.`study_drug`, `Application`.`disease_condition`, `Application`.`product_type_biologicals`, `Application`.`product_type_proteins`, `Application`.`product_type_immunologicals`, `Application`.`product_type_vaccines`, `Application`.`product_type_hormones`, `Application`.`product_type_toxoid`, `Application`.`product_type_chemical`, `Application`.`product_type_medical_device`, `Application`.`product_type_chemical_name`, `Application`.`product_type_medical_device_name`, `Application`.`comparator`, `Application`.`comparator_name`, `Application`.`comparator_registered`, `Application`.`comparator_countries`, `Application`.`ecct_not_applicable`, `Application`.`ecct_ref_number`, `Application`.`email_address`, `Application`.`applicant_covering_letter`, `Application`.`applicant_protocol`, `Application`.`applicant_patient_information`, `Application`.`applicant_investigators_brochure`, `Application`.`applicant_investigators_cv`, `Application`.`applicant_signed_declaration`, `Application`.`applicant_financial_declaration`, `Application`.`applicant_gmp_certificate`, `Application`.`applicant_indemnity_cover`, `Application`.`applicant_opinion_letter`, `Application`.`applicant_approval_letter`, `Application`.`applicant_statement`, `Application`.`applicant_participating_countries`, `Application`.`applicant_addendum`, `Application`.`applicant_fees`, `Application`.`applicant_complete_form`, `Application`.`applicant_impd`, `Application`.`applicant_prev_data`, `Application`.`applicant_stability_data`, `Application`.`applicant_analysis_cert`, `Application`.`applicant_pictorial_sample`, `Application`.`applicant_gcp_training`, `Application`.`applicant_dsmb_charter`, `Application`.`applicant_detailed_budget`, `Application`.`applicant_indemnity_pi`, `Application`.`applicant_practice_license`, `Application`.`applicant_registration_ctr`, `Application`.`applicant_pan_african`, `Application`.`applicant_hard_copies`, `Application`.`applicant_signed_checklist`, `Application`.`statistical_analysis_plan`, `Application`.`applicant_contractual_agreement`, `Application`.`declaration_applicant`, `Application`.`declaration_date1`, `Application`.`declaration_principal_investigator`, `Application`.`declaration_date2`, `Application`.`placebo_present`, `Application`.`study_objectives`, `Application`.`principal_inclusion_criteria`, `Application`.`principal_exclusion_criteria`, `Application`.`primary_end_points`, `Application`.`scope_diagnosis`, `Application`.`scope_prophylaxis`, `Application`.`scope_therapy`, `Application`.`scope_safety`, `Application`.`scope_efficacy`, `Application`.`scope_pharmacokinetic`, `Application`.`scope_pharmacodynamic`, `Application`.`scope_bioequivalence`, `Application`.`scope_dose_response`, `Application`.`scope_pharmacogenetic`, `Application`.`scope_pharmacogenomic`, `Application`.`scope_pharmacoecomomic`, `Application`.`scope_others`, `Application`.`scope_others_specify`, `Application`.`trial_human_pharmacology`, `Application`.`trial_administration_humans`, `Application`.`trial_bioequivalence_study`, `Application`.`trial_other`, `Application`.`trial_other_specify`, `Application`.`trial_therapeutic_exploratory`, `Application`.`trial_therapeutic_confirmatory`, `Application`.`trial_therapeutic_use`, `Application`.`design_controlled`, `Application`.`site_capacity`, `Application`.`staff_numbers`, `Application`.`other_details_explanation`, `Application`.`other_details_regulatory_notapproved`, `Application`.`other_details_regulatory_approved`, `Application`.`other_details_regulatory_rejected`, `Application`.`other_details_regulatory_halted`, `Application`.`estimated_duration`, `Application`.`design_controlled_randomised`, `Application`.`design_controlled_open`, `Application`.`design_controlled_single_blind`, `Application`.`design_controlled_double_blind`, `Application`.`design_controlled_parallel_group`, `Application`.`design_controlled_cross_over`, `Application`.`design_controlled_other`, `Application`.`design_controlled_specify`, `Application`.`design_controlled_comparator`, `Application`.`design_controlled_other_medicinal`, `Application`.`design_controlled_placebo`, `Application`.`design_controlled_medicinal_other`, `Application`.`design_controlled_medicinal_specify`, `Application`.`single_site_member_state`, `Application`.`location_of_area`, `Application`.`single_site_physical_address`, `Application`.`single_site_contact_person`, `Application`.`single_site_telephone`, `Application`.`multiple_sites_member_state`, `Application`.`multiple_countries`, `Application`.`multiple_member_states`, `Application`.`number_of_sites`, `Application`.`multi_country_list`, `Application`.`data_monitoring_committee`, `Application`.`total_enrolment_per_site`, `Application`.`total_participants_worldwide`, `Application`.`population_less_than_18_years`, `Application`.`population_utero`, `Application`.`population_preterm_newborn`, `Application`.`population_newborn`, `Application`.`population_infant_and_toddler`, `Application`.`population_children`, `Application`.`population_adolescent`, `Application`.`population_above_18`, `Application`.`population_adult`, `Application`.`population_elderly`, `Application`.`gender_female`, `Application`.`gender_male`, `Application`.`subjects_healthy`, `Application`.`subjects_patients`, `Application`.`subjects_vulnerable_populations`, `Application`.`subjects_women_child_bearing`, `Application`.`subjects_women_using_contraception`, `Application`.`subjects_pregnant_women`, `Application`.`subjects_nursing_women`, `Application`.`subjects_emergency_situation`, `Application`.`subjects_incapable_consent`, `Application`.`subjects_specify`, `Application`.`subjects_others`, `Application`.`subjects_others_specify`, `Application`.`investigator1_given_name`, `Application`.`investigator1_middle_name`, `Application`.`investigator1_family_name`, `Application`.`investigator1_qualification`, `Application`.`investigator1_professional_address`, `Application`.`investigator1_telephone`, `Application`.`investigator1_email`, `Application`.`organisations_transferred_`, `Application`.`number_participants`, `Application`.`notification`, `Application`.`approval_date`, `Application`.`submitted`, `Application`.`deleted`, `Application`.`deleted_date`, `Application`.`deactivated`, `Application`.`date_submitted`, `Application`.`unsubmitted`, `Application`.`initial_date_submitted`, `Application`.`admin_stopped`, `Application`.`admin_stopped_reason`, `Application`.`approved`, `Application`.`approved_reason`, `Application`.`approved_date`, `Application`.`final_report`, `Application`.`implication_results`, `Application`.`quantity_imported`, `Application`.`quantity_dispensed`, `Application`.`quantity_destroyed`, `Application`.`quantity_exported`, `Application`.`balance_site`, `Application`.`final_date`, `Application`.`ecitizen_invoice`, `Application`.`modified`, `Application`.`created`, `User`.`id`, `User`.`username`, `User`.`password`, `User`.`confirm_password`, `User`.`name`, `User`.`email`, `User`.`national_id_number`, `User`.`sponsor`, `User`.`sponsor_email`, `User`.`qualification`, `User`.`phone_no`, `User`.`name_of_institution`, `User`.`institution_physical`, `User`.`institution_address`, `User`.`institution_contact`, `User`.`county_id`, `User`.`country_id`, `User`.`group_id`, `User`.`activation_key`, `User`.`forgot_password`, `User`.`is_active`, `User`.`deactivated`, `User`.`created`, `User`.`modified`, `TrialStatus`.`id`, `TrialStatus`.`value`, `TrialStatus`.`name`, `TrialStatus`.`created`, `TrialStatus`.`modified` FROM `ctr`.`applications` AS `Application` LEFT JOIN `ctr`.`users` AS `User` ON (`Application`.`user_id` = `User`.`id`) LEFT JOIN `ctr`.`trial_statuses` AS `TrialStatus` ON (`Application`.`trial_status_id` = `TrialStatus`.`id`) WHERE `Application`.`id` = 125 AND `Application`.`deleted` = '0' LIMIT 1	1	1	2	maybe slow
SELECT `Review`.`id`, `Review`.`user_id`, `Review`.`application_id`, `Review`.`type`, `Review`.`assessment_type`, `Review`.`title`, `Review`.`text`, `Review`.`summary`, `Review`.`recommendation`, `Review`.`notified`, `Review`.`accepted`, `Review`.`conflict`, `Review`.`status`, `Review`.`created`, `Review`.`modified` FROM `ctr`.`reviews` AS `Review` WHERE `Review`.`application_id` = (125)	6	6	1	maybe slow
SELECT `ActiveInspector`.`id`, `ActiveInspector`.`user_id`, `ActiveInspector`.`application_id`, `ActiveInspector`.`type`, `ActiveInspector`.`assessment_type`, `ActiveInspector`.`title`, `ActiveInspector`.`text`, `ActiveInspector`.`summary`, `ActiveInspector`.`recommendation`, `ActiveInspector`.`notified`, `ActiveInspector`.`accepted`, `ActiveInspector`.`conflict`, `ActiveInspector`.`status`, `ActiveInspector`.`created`, `ActiveInspector`.`modified` FROM `ctr`.`active_inspectors` AS `ActiveInspector` WHERE `ActiveInspector`.`application_id` = (125)	0	0	0
SELECT `ManagerReview`.`id`, `ManagerReview`.`user_id`, `ManagerReview`.`application_id`, `ManagerReview`.`type`, `ManagerReview`.`assessment_type`, `ManagerReview`.`title`, `ManagerReview`.`text`, `ManagerReview`.`summary`, `ManagerReview`.`recommendation`, `ManagerReview`.`notified`, `ManagerReview`.`accepted`, `ManagerReview`.`conflict`, `ManagerReview`.`status`, `ManagerReview`.`created`, `ManagerReview`.`modified` FROM `ctr`.`reviews` AS `ManagerReview` WHERE `ManagerReview`.`application_id` = (125)	6	6	0
SELECT `Acceptance`.`id`, `Acceptance`.`user_id`, `Acceptance`.`application_id`, `Acceptance`.`type`, `Acceptance`.`assessment_type`, `Acceptance`.`title`, `Acceptance`.`text`, `Acceptance`.`summary`, `Acceptance`.`recommendation`, `Acceptance`.`notified`, `Acceptance`.`accepted`, `Acceptance`.`conflict`, `Acceptance`.`status`, `Acceptance`.`created`, `Acceptance`.`modified` FROM `ctr`.`reviews` AS `Acceptance` WHERE `Acceptance`.`type` = 'acceptance' AND `Acceptance`.`application_id` = (125)	0	0	0
SELECT `Amendment`.`id`, `Amendment`.`application_id`, `Amendment`.`trial_status_id`, `Amendment`.`abstract_of_study`, `Amendment`.`study_title`, `Amendment`.`laymans_summary`, `Amendment`.`protocol_no`, `Amendment`.`version_no`, `Amendment`.`date_of_protocol`, `Amendment`.`study_drug`, `Amendment`.`disease_condition`, `Amendment`.`product_type`, `Amendment`.`product_type_biologicals`, `Amendment`.`product_type_proteins`, `Amendment`.`product_type_immunologicals`, `Amendment`.`product_type_vaccines`, `Amendment`.`product_type_hormones`, `Amendment`.`product_type_toxoid`, `Amendment`.`product_type_chemical`, `Amendment`.`product_type_medical_device`, `Amendment`.`product_type_chemical_name`, `Amendment`.`product_type_medical_device_name`, `Amendment`.`comparator`, `Amendment`.`comparator_name`, `Amendment`.`comparator_registered`, `Amendment`.`comparator_countries`, `Amendment`.`previous_dates`, `Amendment`.`coordinating_investigators`, `Amendment`.`principal_investigators`, `Amendment`.`pharmacist`, `Amendment`.`sponsor_details`, `Amendment`.`gender`, `Amendment`.`details_of_sites`, `Amendment`.`placebos`, `Amendment`.`scopes`, `Amendment`.`organizations`, `Amendment`.`types_and_phases`, `Amendment`.`ecct_not_applicable`, `Amendment`.`ecct_ref_number`, `Amendment`.`email_address`, `Amendment`.`applicant_covering_letter`, `Amendment`.`applicant_protocol`, `Amendment`.`applicant_patient_information`, `Amendment`.`applicant_investigators_brochure`, `Amendment`.`applicant_investigators_cv`, `Amendment`.`applicant_signed_declaration`, `Amendment`.`applicant_financial_declaration`, `Amendment`.`applicant_gmp_certificate`, `Amendment`.`applicant_indemnity_cover`, `Amendment`.`applicant_opinion_letter`, `Amendment`.`applicant_approval_letter`, `Amendment`.`applicant_statement`, `Amendment`.`applicant_participating_countries`, `Amendment`.`applicant_addendum`, `Amendment`.`applicant_fees`, `Amendment`.`declaration_applicant`, `Amendment`.`declaration_date1`, `Amendment`.`declaration_principal_investigator`, `Amendment`.`declaration_date2`, `Amendment`.`placebo_present`, `Amendment`.`study_objectives`, `Amendment`.`principal_inclusion_criteria`, `Amendment`.`principal_exclusion_criteria`, `Amendment`.`primary_end_points`, `Amendment`.`scope_diagnosis`, `Amendment`.`scope_prophylaxis`, `Amendment`.`scope_therapy`, `Amendment`.`scope_safety`, `Amendment`.`scope_efficacy`, `Amendment`.`scope_pharmacokinetic`, `Amendment`.`scope_pharmacodynamic`, `Amendment`.`scope_bioequivalence`, `Amendment`.`scope_dose_response`, `Amendment`.`scope_pharmacogenetic`, `Amendment`.`scope_pharmacogenomic`, `Amendment`.`scope_pharmacoecomomic`, `Amendment`.`scope_others`, `Amendment`.`scope_others_specify`, `Amendment`.`trial_human_pharmacology`, `Amendment`.`trial_administration_humans`, `Amendment`.`trial_bioequivalence_study`, `Amendment`.`trial_other`, `Amendment`.`trial_other_specify`, `Amendment`.`trial_therapeutic_exploratory`, `Amendment`.`trial_therapeutic_confirmatory`, `Amendment`.`trial_therapeutic_use`, `Amendment`.`design_controlled`, `Amendment`.`site_capacity`, `Amendment`.`staff_numbers`, `Amendment`.`other_details_explanation`, `Amendment`.`other_details_regulatory_notapproved`, `Amendment`.`other_details_regulatory_approved`, `Amendment`.`other_details_regulatory_rejected`, `Amendment`.`other_details_regulatory_halted`, `Amendment`.`estimated_duration`, `Amendment`.`design_controlled_randomised`, `Amendment`.`design_controlled_open`, `Amendment`.`design_controlled_single_blind`, `Amendment`.`design_controlled_double_blind`, `Amendment`.`design_controlled_parallel_group`, `Amendment`.`design_controlled_cross_over`, `Amendment`.`design_controlled_other`, `Amendment`.`design_controlled_specify`, `Amendment`.`design_controlled_comparator`, `Amendment`.`design_controlled_other_medicinal`, `Amendment`.`design_controlled_placebo`, `Amendment`.`design_controlled_medicinal_other`, `Amendment`.`design_controlled_medicinal_specify`, `Amendment`.`single_site_member_state`, `Amendment`.`location_of_area`, `Amendment`.`multiple_sites_member_state`, `Amendment`.`multiple_countries`, `Amendment`.`multiple_member_states`, `Amendment`.`number_of_sites`, `Amendment`.`multi_country_list`, `Amendment`.`data_monitoring_committee`, `Amendment`.`total_enrolment_per_site`, `Amendment`.`total_participants_worldwide`, `Amendment`.`population_less_than_18_years`, `Amendment`.`population_utero`, `Amendment`.`population_preterm_newborn`, `Amendment`.`population_newborn`, `Amendment`.`population_infant_and_toddler`, `Amendment`.`population_children`, `Amendment`.`population_adolescent`, `Amendment`.`population_above_18`, `Amendment`.`population_adult`, `Amendment`.`population_elderly`, `Amendment`.`gender_female`, `Amendment`.`gender_male`, `Amendment`.`subjects_healthy`, `Amendment`.`subjects_patients`, `Amendment`.`subjects_vulnerable_populations`, `Amendment`.`subjects_women_child_bearing`, `Amendment`.`subjects_women_using_contraception`, `Amendment`.`subjects_pregnant_women`, `Amendment`.`subjects_nursing_women`, `Amendment`.`subjects_emergency_situation`, `Amendment`.`subjects_incapable_consent`, `Amendment`.`subjects_specify`, `Amendment`.`subjects_others`, `Amendment`.`subjects_others_specify`, `Amendment`.`investigator1_given_name`, `Amendment`.`investigator1_middle_name`, `Amendment`.`investigator1_family_name`, `Amendment`.`investigator1_qualification`, `Amendment`.`investigator1_professional_address`, `Amendment`.`organisations_transferred_`, `Amendment`.`number_participants`, `Amendment`.`notification`, `Amendment`.`approval_date`, `Amendment`.`submitted`, `Amendment`.`date_submitted`, `Amendment`.`modified`, `Amendment`.`created` FROM `ctr`.`amendments` AS `Amendment` WHERE `Amendment`.`application_id` = (125)	3	3	1	maybe slow
SELECT `InvestigatorContact`.`id`, `InvestigatorContact`.`application_id`, `InvestigatorContact`.`given_name`, `InvestigatorContact`.`middle_name`, `InvestigatorContact`.`family_name`, `InvestigatorContact`.`qualification`, `InvestigatorContact`.`professional_address`, `InvestigatorContact`.`telephone`, `InvestigatorContact`.`email`, `InvestigatorContact`.`created`, `InvestigatorContact`.`modified` FROM `ctr`.`investigator_contacts` AS `InvestigatorContact` WHERE `InvestigatorContact`.`application_id` = (125)	1	1	0
SELECT `ApplicationStage`.`id`, `ApplicationStage`.`application_id`, `ApplicationStage`.`stage`, `ApplicationStage`.`start_date`, `ApplicationStage`.`status`, `ApplicationStage`.`comment`, `ApplicationStage`.`end_date`, `ApplicationStage`.`created`, `ApplicationStage`.`modified` FROM `ctr`.`application_stages` AS `ApplicationStage` WHERE `ApplicationStage`.`application_id` = (125)	8	8	0
SELECT `Pharmacist`.`id`, `Pharmacist`.`application_id`, `Pharmacist`.`reg_no`, `Pharmacist`.`given_name`, `Pharmacist`.`premise_name`, `Pharmacist`.`qualification`, `Pharmacist`.`professional_address`, `Pharmacist`.`valid_year`, `Pharmacist`.`mobile`, `Pharmacist`.`telephone`, `Pharmacist`.`email`, `Pharmacist`.`created`, `Pharmacist`.`modified` FROM `ctr`.`pharmacists` AS `Pharmacist` WHERE `Pharmacist`.`application_id` = (125)	1	1	0
SELECT `EthicalCommittee`.`id`, `EthicalCommittee`.`application_id`, `EthicalCommittee`.`ethical_committee`, `EthicalCommittee`.`submission_date`, `EthicalCommittee`.`erc_number`, `EthicalCommittee`.`initial_approval`, `EthicalCommittee`.`created`, `EthicalCommittee`.`modified` FROM `ctr`.`ethical_committees` AS `EthicalCommittee` WHERE `EthicalCommittee`.`application_id` = (125)	1	1	0
SELECT `AnnualLetter`.`id`, `AnnualLetter`.`application_id`, `AnnualLetter`.`approval_no`, `AnnualLetter`.`type`, `AnnualLetter`.`content`, `AnnualLetter`.`qrcode`, `AnnualLetter`.`approver`, `AnnualLetter`.`approval_date`, `AnnualLetter`.`expiry_date`, `AnnualLetter`.`status`, `AnnualLetter`.`deleted`, `AnnualLetter`.`deleted_date`, `AnnualLetter`.`created`, `AnnualLetter`.`modified` FROM `ctr`.`annual_letters` AS `AnnualLetter` WHERE `AnnualLetter`.`deleted` = '0' AND `AnnualLetter`.`application_id` = (125)	19	19	3	maybe slow
SELECT `AmendmentLetter`.`id`, `AmendmentLetter`.`application_id`, `AmendmentLetter`.`approval_no`, `AmendmentLetter`.`content`, `AmendmentLetter`.`qrcode`, `AmendmentLetter`.`approver`, `AmendmentLetter`.`approval_date`, `AmendmentLetter`.`expiry_date`, `AmendmentLetter`.`status`, `AmendmentLetter`.`submitted`, `AmendmentLetter`.`deleted`, `AmendmentLetter`.`deleted_date`, `AmendmentLetter`.`created`, `AmendmentLetter`.`modified` FROM `ctr`.`amendment_letters` AS `AmendmentLetter` WHERE `AmendmentLetter`.`application_id` = (125)	4	4	1	maybe slow
SELECT `AmendmentApproval`.`id`, `AmendmentApproval`.`application_id`, `AmendmentApproval`.`approval_no`, `AmendmentApproval`.`amendment`, `AmendmentApproval`.`content`, `AmendmentApproval`.`approver`, `AmendmentApproval`.`approval_date`, `AmendmentApproval`.`status`, `AmendmentApproval`.`deleted`, `AmendmentApproval`.`deleted_date`, `AmendmentApproval`.`created`, `AmendmentApproval`.`modified` FROM `ctr`.`amendment_approvals` AS `AmendmentApproval` WHERE `AmendmentApproval`.`application_id` = (125)	8	8	0
SELECT `AmendmentApprovalSummary`.`id`, `AmendmentApprovalSummary`.`application_id`, `AmendmentApprovalSummary`.`approval_no`, `AmendmentApprovalSummary`.`amendment`, `AmendmentApprovalSummary`.`content`, `AmendmentApprovalSummary`.`approver`, `AmendmentApprovalSummary`.`approval_date`, `AmendmentApprovalSummary`.`status`, `AmendmentApprovalSummary`.`deleted`, `AmendmentApprovalSummary`.`deleted_date`, `AmendmentApprovalSummary`.`created`, `AmendmentApprovalSummary`.`modified` FROM `ctr`.`amendment_approvals` AS `AmendmentApprovalSummary` WHERE `AmendmentApprovalSummary`.`status` = 'summary' AND `AmendmentApprovalSummary`.`application_id` = (125)	0	0	0
SELECT `Organization`.`id`, `Organization`.`application_id`, `Organization`.`organization`, `Organization`.`contact_person`, `Organization`.`address`, `Organization`.`telephone_number`, `Organization`.`all_tasks`, `Organization`.`monitoring`, `Organization`.`regulatory`, `Organization`.`investigator_recruitment`, `Organization`.`ivrs_treatment_randomisation`, `Organization`.`data_management`, `Organization`.`e_data_capture`, `Organization`.`susar_reporting`, `Organization`.`quality_assurance_auditing`, `Organization`.`statistical_analysis`, `Organization`.`medical_writing`, `Organization`.`other_duties`, `Organization`.`other_duties_specify`, `Organization`.`misc`, `Organization`.`created`, `Organization`.`modified` FROM `ctr`.`organizations` AS `Organization` WHERE `Organization`.`application_id` = (125)	1	1	0
SELECT `SiteDetail`.`id`, `SiteDetail`.`application_id`, `SiteDetail`.`county_id`, `SiteDetail`.`site_name`, `SiteDetail`.`physical_address`, `SiteDetail`.`contact_details`, `SiteDetail`.`contact_person`, `SiteDetail`.`site_capacity`, `SiteDetail`.`misc`, `SiteDetail`.`created`, `SiteDetail`.`modified` FROM `ctr`.`site_details` AS `SiteDetail` WHERE `SiteDetail`.`application_id` = (125)	1	1	1
SELECT `Placebo`.`id`, `Placebo`.`application_id`, `Placebo`.`placebo_present`, `Placebo`.`pharmaceutical_form`, `Placebo`.`route_of_administration`, `Placebo`.`composition`, `Placebo`.`identical_indp`, `Placebo`.`major_ingredients`, `Placebo`.`created`, `Placebo`.`modified` FROM `ctr`.`placebos` AS `Placebo` WHERE `Placebo`.`application_id` = (125)	1	1	0
SELECT `Sponsor`.`id`, `Sponsor`.`application_id`, `Sponsor`.`sponsor`, `Sponsor`.`sponsor_type`, `Sponsor`.`contact_person`, `Sponsor`.`address`, `Sponsor`.`telephone_number`, `Sponsor`.`fax_number`, `Sponsor`.`cell_number`, `Sponsor`.`email_address`, `Sponsor`.`created`, `Sponsor`.`modified` FROM `ctr`.`sponsors` AS `Sponsor` WHERE `Sponsor`.`application_id` = (125)	1	1	0
SELECT `SiteInspection`.`id`, `SiteInspection`.`application_id`, `SiteInspection`.`user_id`, `SiteInspection`.`reference_no`, `SiteInspection`.`study_title`, `SiteInspection`.`protocol_no`, `SiteInspection`.`version_no`, `SiteInspection`.`pactr_number`, `SiteInspection`.`trial_phase`, `SiteInspection`.`investigators`, `SiteInspection`.`co_investigators`, `SiteInspection`.`study_stage`, `SiteInspection`.`inspection_country`, `SiteInspection`.`inspector_names`, `SiteInspection`.`inspection_dates`, `SiteInspection`.`site_address`, `SiteInspection`.`sponsor_address`, `SiteInspection`.`lab_address`, `SiteInspection`.`events_summary`, `SiteInspection`.`conclusion`, `SiteInspection`.`summary_report`, `SiteInspection`.`outcome`, `SiteInspection`.`approved`, `SiteInspection`.`summary_approved`, `SiteInspection`.`approved_by`, `SiteInspection`.`sent_to_pi`, `SiteInspection`.`deleted`, `SiteInspection`.`deleted_date`, `SiteInspection`.`created`, `SiteInspection`.`modified` FROM `ctr`.`site_inspections` AS `SiteInspection` WHERE `SiteInspection`.`deleted` = '0' AND `SiteInspection`.`application_id` = (125)	0	0	0
SELECT `Sae`.`id`, `Sae`.`application_id`, `Sae`.`sae_id`, `Sae`.`reference_no`, `Sae`.`form_type`, `Sae`.`user_id`, `Sae`.`patient_initials`, `Sae`.`country_id`, `Sae`.`date_of_birth`, `Sae`.`age_years`, `Sae`.`gender`, `Sae`.`causality`, `Sae`.`enrollment_date`, `Sae`.`administration_date`, `Sae`.`latest_date`, `Sae`.`reaction_onset`, `Sae`.`reaction_end_date`, `Sae`.`patient_died`, `Sae`.`prolonged_hospitalization`, `Sae`.`incapacity`, `Sae`.`life_threatening`, `Sae`.`reaction_other`, `Sae`.`reaction_description`, `Sae`.`relevant_history`, `Sae`.`manufacturer_name`, `Sae`.`mfr_no`, `Sae`.`manufacturer_date`, `Sae`.`source_study`, `Sae`.`source_literature`, `Sae`.`source_health_professional`, `Sae`.`report_date`, `Sae`.`report_type`, `Sae`.`approved`, `Sae`.`date_submitted`, `Sae`.`approved_by`, `Sae`.`email_address`, `Sae`.`reporter_name`, `Sae`.`reporter_phone`, `Sae`.`reporter_email`, `Sae`.`deleted`, `Sae`.`deleted_date`, `Sae`.`created`, `Sae`.`modified` FROM `ctr`.`saes` AS `Sae` WHERE `Sae`.`application_id` = (125)	2	2	0
SELECT `Ciom`.`id`, `Ciom`.`application_id`, `Ciom`.`reference_no`, `Ciom`.`user_id`, `Ciom`.`reporter_email`, `Ciom`.`e2b_content`, `Ciom`.`e2b_file`, `Ciom`.`file`, `Ciom`.`dirname`, `Ciom`.`basename`, `Ciom`.`checksum`, `Ciom`.`alternative`, `Ciom`.`group`, `Ciom`.`description`, `Ciom`.`created`, `Ciom`.`modified` FROM `ctr`.`cioms` AS `Ciom` WHERE `Ciom`.`application_id` = (125)	0	0	0
SELECT `StudyRoute`.`id`, `StudyRoute`.`application_id`, `StudyRoute`.`study_route`, `StudyRoute`.`created`, `StudyRoute`.`modified` FROM `ctr`.`study_routes` AS `StudyRoute` WHERE `StudyRoute`.`application_id` = (125)	1	1	0
SELECT `Manufacturer`.`id`, `Manufacturer`.`application_id`, `Manufacturer`.`manufacturer_name`, `Manufacturer`.`address`, `Manufacturer`.`manufacturer_country`, `Manufacturer`.`manufacturer_phone`, `Manufacturer`.`manufacturer_email`, `Manufacturer`.`manufacturing_activities`, `Manufacturer`.`other_specify`, `Manufacturer`.`created`, `Manufacturer`.`modified` FROM `ctr`.`manufacturers` AS `Manufacturer` WHERE `Manufacturer`.`application_id` = (125)	1	1	0
SELECT `Reassignment`.`id`, `Reassignment`.`application_id`, `Reassignment`.`orig_user`, `Reassignment`.`new_user`, `Reassignment`.`assigning_user`, `Reassignment`.`created`, `Reassignment`.`modified` FROM `ctr`.`reassignments` AS `Reassignment` WHERE `Reassignment`.`application_id` = (125)	0	0	0
SELECT `Attachment`.`id`, `Attachment`.`model`, `Attachment`.`file`, `Attachment`.`foreign_key`, `Attachment`.`dirname`, `Attachment`.`basename`, `Attachment`.`checksum`, `Attachment`.`alternative`, `Attachment`.`group`, `Attachment`.`description`, `Attachment`.`year`, `Attachment`.`file_date`, `Attachment`.`pocket_name`, `Attachment`.`version_no`, `Attachment`.`created`, `Attachment`.`modified`, (CONCAT_WS('/', dirname, basename)) AS `Attachment__path` FROM `ctr`.`attachments` AS `Attachment` WHERE `Attachment`.`model` = 'Application' AND `Attachment`.`group` = 'attachment' AND `Attachment`.`foreign_key` = (125)	4	4	2	maybe slow
SELECT `AnnualApproval`.`id`, `AnnualApproval`.`model`, `AnnualApproval`.`file`, `AnnualApproval`.`foreign_key`, `AnnualApproval`.`dirname`, `AnnualApproval`.`basename`, `AnnualApproval`.`checksum`, `AnnualApproval`.`alternative`, `AnnualApproval`.`group`, `AnnualApproval`.`description`, `AnnualApproval`.`year`, `AnnualApproval`.`file_date`, `AnnualApproval`.`pocket_name`, `AnnualApproval`.`version_no`, `AnnualApproval`.`created`, `AnnualApproval`.`modified`, (CONCAT_WS('/', dirname, basename)) AS `AnnualApproval__path` FROM `ctr`.`attachments` AS `AnnualApproval` WHERE `AnnualApproval`.`model` = 'AnnualApproval' AND `AnnualApproval`.`foreign_key` = (125)	15	15	2	maybe slow
SELECT `AmendmentChecklist`.`id`, `AmendmentChecklist`.`model`, `AmendmentChecklist`.`file`, `AmendmentChecklist`.`foreign_key`, `AmendmentChecklist`.`dirname`, `AmendmentChecklist`.`basename`, `AmendmentChecklist`.`checksum`, `AmendmentChecklist`.`alternative`, `AmendmentChecklist`.`group`, `AmendmentChecklist`.`description`, `AmendmentChecklist`.`year`, `AmendmentChecklist`.`file_date`, `AmendmentChecklist`.`pocket_name`, `AmendmentChecklist`.`version_no`, `AmendmentChecklist`.`created`, `AmendmentChecklist`.`modified`, (CONCAT_WS('/', dirname, basename)) AS `AmendmentChecklist__path` FROM `ctr`.`attachments` AS `AmendmentChecklist` WHERE `AmendmentChecklist`.`model` = 'AmendmentChecklist' AND `AmendmentChecklist`.`foreign_key` = (125)	0	0	2	maybe slow
SELECT `Reminder`.`id`, `Reminder`.`foreign_key`, `Reminder`.`model`, `Reminder`.`user_id`, `Reminder`.`reminder_type`, `Reminder`.`created`, `Reminder`.`modified` FROM `ctr`.`reminders` AS `Reminder` WHERE `Reminder`.`model` = 'Application' AND `Reminder`.`foreign_key` = (125)	0	0	0
SELECT `ParticipantFlow`.`id`, `ParticipantFlow`.`application_id`, `ParticipantFlow`.`year`, `ParticipantFlow`.`original_subjects`, `ParticipantFlow`.`consented`, `ParticipantFlow`.`screened`, `ParticipantFlow`.`enrolled`, `ParticipantFlow`.`lost`, `ParticipantFlow`.`lost_reason`, `ParticipantFlow`.`withdrawn`, `ParticipantFlow`.`withdrawal_reason`, `ParticipantFlow`.`self_withdrawal`, `ParticipantFlow`.`self_withdrawal_reasons`, `ParticipantFlow`.`active_subjects`, `ParticipantFlow`.`completed_number`, `ParticipantFlow`.`created`, `ParticipantFlow`.`modified` FROM `ctr`.`participant_flows` AS `ParticipantFlow` WHERE `ParticipantFlow`.`application_id` = (125)	0	0	0
SELECT `Budget`.`id`, `Budget`.`application_id`, `Budget`.`year`, `Budget`.`budget_period`, `Budget`.`personnel_currency`, `Budget`.`personnel`, `Budget`.`transport_currency`, `Budget`.`transport`, `Budget`.`field_currency`, `Budget`.`field`, `Budget`.`supplies_currency`, `Budget`.`supplies`, `Budget`.`pharmacy_currency`, `Budget`.`pharmacy`, `Budget`.`travel_currency`, `Budget`.`travel`, `Budget`.`regulatory_currency`, `Budget`.`regulatory`, `Budget`.`it_currency`, `Budget`.`it`, `Budget`.`lab_currency`, `Budget`.`lab`, `Budget`.`others_currency`, `Budget`.`others`, `Budget`.`kemri_currency`, `Budget`.`kemri`, `Budget`.`wrair_currency`, `Budget`.`wrair`, `Budget`.`subject_currency`, `Budget`.`subject`, `Budget`.`grand_currency`, `Budget`.`grand_total`, `Budget`.`study_information`, `Budget`.`personnel_kshs`, `Budget`.`transport_kshs`, `Budget`.`field_kshs`, `Budget`.`supplies_kshs`, `Budget`.`pharmacy_kshs`, `Budget`.`travel_kshs`, `Budget`.`regulatory_kshs`, `Budget`.`it_kshs`, `Budget`.`lab_kshs`, `Budget`.`others_kshs`, `Budget`.`grand_total_kshs`, `Budget`.`subject_kshs`, `Budget`.`created`, `Budget`.`modified` FROM `ctr`.`budgets` AS `Budget` WHERE `Budget`.`application_id` = (125)	1	1	0
SELECT `Deviation`.`id`, `Deviation`.`application_id`, `Deviation`.`user_id`, `Deviation`.`reference_no`, `Deviation`.`study_title`, `Deviation`.`deviation_type`, `Deviation`.`deviation_type_dev`, `Deviation`.`pi_name`, `Deviation`.`deviation_date`, `Deviation`.`participant_number`, `Deviation`.`treating_physician`, `Deviation`.`deviation_description`, `Deviation`.`deviation_explanation`, `Deviation`.`deviation_measures`, `Deviation`.`deviation_preclude`, `Deviation`.`sponsor_notified`, `Deviation`.`sponsor_explanation`, `Deviation`.`study_impact`, `Deviation`.`status`, `Deviation`.`deleted`, `Deviation`.`deleted_date`, `Deviation`.`created`, `Deviation`.`modified` FROM `ctr`.`deviations` AS `Deviation` WHERE `Deviation`.`application_id` = (125)	0	0	0
SELECT `Document`.`id`, `Document`.`model`, `Document`.`file`, `Document`.`foreign_key`, `Document`.`dirname`, `Document`.`basename`, `Document`.`checksum`, `Document`.`alternative`, `Document`.`group`, `Document`.`description`, `Document`.`year`, `Document`.`file_date`, `Document`.`pocket_name`, `Document`.`version_no`, `Document`.`created`, `Document`.`modified`, (CONCAT_WS('/', dirname, basename)) AS `Document__path` FROM `ctr`.`attachments` AS `Document` WHERE `Document`.`model` = 'Application' AND `Document`.`group` = 'document' AND `Document`.`foreign_key` = (125)	0	0	2	maybe slow
SELECT `CoverLetter`.`id`, `CoverLetter`.`model`, `CoverLetter`.`file`, `CoverLetter`.`foreign_key`, `CoverLetter`.`dirname`, `CoverLetter`.`basename`, `CoverLetter`.`checksum`, `CoverLetter`.`alternative`, `CoverLetter`.`group`, `CoverLetter`.`description`, `CoverLetter`.`year`, `CoverLetter`.`file_date`, `CoverLetter`.`pocket_name`, `CoverLetter`.`version_no`, `CoverLetter`.`created`, `CoverLetter`.`modified`, (CONCAT_WS('/', dirname, basename)) AS `CoverLetter__path` FROM `ctr`.`attachments` AS `CoverLetter` WHERE `CoverLetter`.`model` = 'Application' AND `CoverLetter`.`group` = 'cover_letter' AND `CoverLetter`.`foreign_key` = (125)	0	0	2	maybe slow
SELECT `Protocol`.`id`, `Protocol`.`model`, `Protocol`.`file`, `Protocol`.`foreign_key`, `Protocol`.`dirname`, `Protocol`.`basename`, `Protocol`.`checksum`, `Protocol`.`alternative`, `Protocol`.`group`, `Protocol`.`description`, `Protocol`.`year`, `Protocol`.`file_date`, `Protocol`.`pocket_name`, `Protocol`.`version_no`, `Protocol`.`created`, `Protocol`.`modified`, (CONCAT_WS('/', dirname, basename)) AS `Protocol__path` FROM `ctr`.`attachments` AS `Protocol` WHERE `Protocol`.`model` = 'Application' AND `Protocol`.`group` = 'protocol' AND `Protocol`.`foreign_key` = (125)	0	0	2	maybe slow
SELECT `PatientLeaflet`.`id`, `PatientLeaflet`.`model`, `PatientLeaflet`.`file`, `PatientLeaflet`.`foreign_key`, `PatientLeaflet`.`dirname`, `PatientLeaflet`.`basename`, `PatientLeaflet`.`checksum`, `PatientLeaflet`.`alternative`, `PatientLeaflet`.`group`, `PatientLeaflet`.`description`, `PatientLeaflet`.`year`, `PatientLeaflet`.`file_date`, `PatientLeaflet`.`pocket_name`, `PatientLeaflet`.`version_no`, `PatientLeaflet`.`created`, `PatientLeaflet`.`modified`, (CONCAT_WS('/', dirname, basename)) AS `PatientLeaflet__path` FROM `ctr`.`attachments` AS `PatientLeaflet` WHERE `PatientLeaflet`.`model` = 'Application' AND `PatientLeaflet`.`group` = 'patient_leaflet' AND `PatientLeaflet`.`foreign_key` = (125)	0	0	2	maybe slow
SELECT `Brochure`.`id`, `Brochure`.`model`, `Brochure`.`file`, `Brochure`.`foreign_key`, `Brochure`.`dirname`, `Brochure`.`basename`, `Brochure`.`checksum`, `Brochure`.`alternative`, `Brochure`.`group`, `Brochure`.`description`, `Brochure`.`year`, `Brochure`.`file_date`, `Brochure`.`pocket_name`, `Brochure`.`version_no`, `Brochure`.`created`, `Brochure`.`modified`, (CONCAT_WS('/', dirname, basename)) AS `Brochure__path` FROM `ctr`.`attachments` AS `Brochure` WHERE `Brochure`.`model` = 'Application' AND `Brochure`.`group` = 'brochure' AND `Brochure`.`foreign_key` = (125)	0	0	2	maybe slow
SELECT `GmpCertificate`.`id`, `GmpCertificate`.`model`, `GmpCertificate`.`file`, `GmpCertificate`.`foreign_key`, `GmpCertificate`.`dirname`, `GmpCertificate`.`basename`, `GmpCertificate`.`checksum`, `GmpCertificate`.`alternative`, `GmpCertificate`.`group`, `GmpCertificate`.`description`, `GmpCertificate`.`year`, `GmpCertificate`.`file_date`, `GmpCertificate`.`pocket_name`, `GmpCertificate`.`version_no`, `GmpCertificate`.`created`, `GmpCertificate`.`modified`, (CONCAT_WS('/', dirname, basename)) AS `GmpCertificate__path` FROM `ctr`.`attachments` AS `GmpCertificate` WHERE `GmpCertificate`.`model` = 'Application' AND `GmpCertificate`.`group` = 'gmp_certificate' AND `GmpCertificate`.`foreign_key` = (125)	0	0	2	maybe slow
SELECT `Cv`.`id`, `Cv`.`model`, `Cv`.`file`, `Cv`.`foreign_key`, `Cv`.`dirname`, `Cv`.`basename`, `Cv`.`checksum`, `Cv`.`alternative`, `Cv`.`group`, `Cv`.`description`, `Cv`.`year`, `Cv`.`file_date`, `Cv`.`pocket_name`, `Cv`.`version_no`, `Cv`.`created`, `Cv`.`modified`, (CONCAT_WS('/', dirname, basename)) AS `Cv__path` FROM `ctr`.`attachments` AS `Cv` WHERE `Cv`.`model` = 'Application' AND `Cv`.`group` = 'cv' AND `Cv`.`foreign_key` = (125)	0	0	2	maybe slow
SELECT `Finance`.`id`, `Finance`.`model`, `Finance`.`file`, `Finance`.`foreign_key`, `Finance`.`dirname`, `Finance`.`basename`, `Finance`.`checksum`, `Finance`.`alternative`, `Finance`.`group`, `Finance`.`description`, `Finance`.`year`, `Finance`.`file_date`, `Finance`.`pocket_name`, `Finance`.`version_no`, `Finance`.`created`, `Finance`.`modified`, (CONCAT_WS('/', dirname, basename)) AS `Finance__path` FROM `ctr`.`attachments` AS `Finance` WHERE `Finance`.`model` = 'Application' AND `Finance`.`group` = 'finance' AND `Finance`.`foreign_key` = (125)	0	0	2	maybe slow
SELECT `Declaration`.`id`, `Declaration`.`model`, `Declaration`.`file`, `Declaration`.`foreign_key`, `Declaration`.`dirname`, `Declaration`.`basename`, `Declaration`.`checksum`, `Declaration`.`alternative`, `Declaration`.`group`, `Declaration`.`description`, `Declaration`.`year`, `Declaration`.`file_date`, `Declaration`.`pocket_name`, `Declaration`.`version_no`, `Declaration`.`created`, `Declaration`.`modified`, (CONCAT_WS('/', dirname, basename)) AS `Declaration__path` FROM `ctr`.`attachments` AS `Declaration` WHERE `Declaration`.`model` = 'Application' AND `Declaration`.`group` = 'declaration' AND `Declaration`.`foreign_key` = (125)	0	0	2	maybe slow
SELECT `IndemnityCover`.`id`, `IndemnityCover`.`model`, `IndemnityCover`.`file`, `IndemnityCover`.`foreign_key`, `IndemnityCover`.`dirname`, `IndemnityCover`.`basename`, `IndemnityCover`.`checksum`, `IndemnityCover`.`alternative`, `IndemnityCover`.`group`, `IndemnityCover`.`description`, `IndemnityCover`.`year`, `IndemnityCover`.`file_date`, `IndemnityCover`.`pocket_name`, `IndemnityCover`.`version_no`, `IndemnityCover`.`created`, `IndemnityCover`.`modified`, (CONCAT_WS('/', dirname, basename)) AS `IndemnityCover__path` FROM `ctr`.`attachments` AS `IndemnityCover` WHERE `IndemnityCover`.`model` = 'Application' AND `IndemnityCover`.`group` = 'indemnity_cover' AND `IndemnityCover`.`foreign_key` = (125)	0	0	2	maybe slow
SELECT `OpinionLetter`.`id`, `OpinionLetter`.`model`, `OpinionLetter`.`file`, `OpinionLetter`.`foreign_key`, `OpinionLetter`.`dirname`, `OpinionLetter`.`basename`, `OpinionLetter`.`checksum`, `OpinionLetter`.`alternative`, `OpinionLetter`.`group`, `OpinionLetter`.`description`, `OpinionLetter`.`year`, `OpinionLetter`.`file_date`, `OpinionLetter`.`pocket_name`, `OpinionLetter`.`version_no`, `OpinionLetter`.`created`, `OpinionLetter`.`modified`, (CONCAT_WS('/', dirname, basename)) AS `OpinionLetter__path` FROM `ctr`.`attachments` AS `OpinionLetter` WHERE `OpinionLetter`.`model` = 'Application' AND `OpinionLetter`.`group` = 'opinion_letter' AND `OpinionLetter`.`foreign_key` = (125)	0	0	2	maybe slow
SELECT `ApprovalLetter`.`id`, `ApprovalLetter`.`model`, `ApprovalLetter`.`file`, `ApprovalLetter`.`foreign_key`, `ApprovalLetter`.`dirname`, `ApprovalLetter`.`basename`, `ApprovalLetter`.`checksum`, `ApprovalLetter`.`alternative`, `ApprovalLetter`.`group`, `ApprovalLetter`.`description`, `ApprovalLetter`.`year`, `ApprovalLetter`.`file_date`, `ApprovalLetter`.`pocket_name`, `ApprovalLetter`.`version_no`, `ApprovalLetter`.`created`, `ApprovalLetter`.`modified`, (CONCAT_WS('/', dirname, basename)) AS `ApprovalLetter__path` FROM `ctr`.`attachments` AS `ApprovalLetter` WHERE `ApprovalLetter`.`model` = 'Application' AND `ApprovalLetter`.`group` = 'approval_letter' AND `ApprovalLetter`.`foreign_key` = (125)	0	0	2	maybe slow
SELECT `Statement`.`id`, `Statement`.`model`, `Statement`.`file`, `Statement`.`foreign_key`, `Statement`.`dirname`, `Statement`.`basename`, `Statement`.`checksum`, `Statement`.`alternative`, `Statement`.`group`, `Statement`.`description`, `Statement`.`year`, `Statement`.`file_date`, `Statement`.`pocket_name`, `Statement`.`version_no`, `Statement`.`created`, `Statement`.`modified`, (CONCAT_WS('/', dirname, basename)) AS `Statement__path` FROM `ctr`.`attachments` AS `Statement` WHERE `Statement`.`model` = 'Application' AND `Statement`.`group` = 'statement' AND `Statement`.`foreign_key` = (125)	0	0	2	maybe slow
SELECT `ParticipatingStudy`.`id`, `ParticipatingStudy`.`model`, `ParticipatingStudy`.`file`, `ParticipatingStudy`.`foreign_key`, `ParticipatingStudy`.`dirname`, `ParticipatingStudy`.`basename`, `ParticipatingStudy`.`checksum`, `ParticipatingStudy`.`alternative`, `ParticipatingStudy`.`group`, `ParticipatingStudy`.`description`, `ParticipatingStudy`.`year`, `ParticipatingStudy`.`file_date`, `ParticipatingStudy`.`pocket_name`, `ParticipatingStudy`.`version_no`, `ParticipatingStudy`.`created`, `ParticipatingStudy`.`modified`, (CONCAT_WS('/', dirname, basename)) AS `ParticipatingStudy__path` FROM `ctr`.`attachments` AS `ParticipatingStudy` WHERE `ParticipatingStudy`.`model` = 'Application' AND `ParticipatingStudy`.`group` = 'participating_study' AND `ParticipatingStudy`.`foreign_key` = (125)	0	0	2	maybe slow
SELECT `Addendum`.`id`, `Addendum`.`model`, `Addendum`.`file`, `Addendum`.`foreign_key`, `Addendum`.`dirname`, `Addendum`.`basename`, `Addendum`.`checksum`, `Addendum`.`alternative`, `Addendum`.`group`, `Addendum`.`description`, `Addendum`.`year`, `Addendum`.`file_date`, `Addendum`.`pocket_name`, `Addendum`.`version_no`, `Addendum`.`created`, `Addendum`.`modified`, (CONCAT_WS('/', dirname, basename)) AS `Addendum__path` FROM `ctr`.`attachments` AS `Addendum` WHERE `Addendum`.`model` = 'Application' AND `Addendum`.`group` = 'addendum' AND `Addendum`.`foreign_key` = (125)	0	0	2	maybe slow
SELECT `Registration`.`id`, `Registration`.`model`, `Registration`.`file`, `Registration`.`foreign_key`, `Registration`.`dirname`, `Registration`.`basename`, `Registration`.`checksum`, `Registration`.`alternative`, `Registration`.`group`, `Registration`.`description`, `Registration`.`year`, `Registration`.`file_date`, `Registration`.`pocket_name`, `Registration`.`version_no`, `Registration`.`created`, `Registration`.`modified`, (CONCAT_WS('/', dirname, basename)) AS `Registration__path` FROM `ctr`.`attachments` AS `Registration` WHERE `Registration`.`model` = 'Application' AND `Registration`.`group` = 'registration' AND `Registration`.`foreign_key` = (125)	0	0	2	maybe slow
SELECT `Fee`.`id`, `Fee`.`model`, `Fee`.`file`, `Fee`.`foreign_key`, `Fee`.`dirname`, `Fee`.`basename`, `Fee`.`checksum`, `Fee`.`alternative`, `Fee`.`group`, `Fee`.`description`, `Fee`.`year`, `Fee`.`file_date`, `Fee`.`pocket_name`, `Fee`.`version_no`, `Fee`.`created`, `Fee`.`modified`, (CONCAT_WS('/', dirname, basename)) AS `Fee__path` FROM `ctr`.`attachments` AS `Fee` WHERE `Fee`.`model` = 'Application' AND `Fee`.`group` = 'fee' AND `Fee`.`foreign_key` = (125)	0	0	2	maybe slow
SELECT `Checklist`.`id`, `Checklist`.`model`, `Checklist`.`file`, `Checklist`.`foreign_key`, `Checklist`.`dirname`, `Checklist`.`basename`, `Checklist`.`checksum`, `Checklist`.`alternative`, `Checklist`.`group`, `Checklist`.`description`, `Checklist`.`year`, `Checklist`.`file_date`, `Checklist`.`pocket_name`, `Checklist`.`version_no`, `Checklist`.`created`, `Checklist`.`modified`, (CONCAT_WS('/', dirname, basename)) AS `Checklist__path` FROM `ctr`.`attachments` AS `Checklist` WHERE `Checklist`.`model` = 'Checklist' AND `Checklist`.`foreign_key` = (125)	28	28	2	maybe slow
SELECT `StudyMonitor`.`id`, `StudyMonitor`.`user_id`, `StudyMonitor`.`application_id`, `StudyMonitor`.`amendment_id`, `StudyMonitor`.`owner_id`, `StudyMonitor`.`created`, `StudyMonitor`.`modified` FROM `ctr`.`study_monitors` AS `StudyMonitor` WHERE `StudyMonitor`.`user_id` = (125)	0	0	0
SELECT `ProtocolOutsource`.`id`, `ProtocolOutsource`.`user_id`, `ProtocolOutsource`.`application_id`, `ProtocolOutsource`.`outsource_id`, `ProtocolOutsource`.`owner_id`, `ProtocolOutsource`.`created`, `ProtocolOutsource`.`modified` FROM `ctr`.`protocol_outsources` AS `ProtocolOutsource` WHERE `ProtocolOutsource`.`user_id` = (125)	0	0	0
SELECT `Outsource`.`id`, `Outsource`.`application_id`, `Outsource`.`user_id`, `Outsource`.`model`, `Outsource`.`username`, `Outsource`.`name`, `Outsource`.`email`, `Outsource`.`phone_no`, `Outsource`.`institution_physical`, `Outsource`.`name_of_institution`, `Outsource`.`institution_address`, `Outsource`.`institution_contact`, `Outsource`.`county_id`, `Outsource`.`country_id`, `Outsource`.`approved`, `Outsource`.`created`, `Outsource`.`modified`, `Outsource`.`accepted`, `Outsource`.`model_sae`, `Outsource`.`model_ciom`, `Outsource`.`model_dev` FROM `ctr`.`outsources` AS `Outsource` WHERE `Outsource`.`application_id` = (125)	0	0	0

Query Explain:

Click an "Explain" link above, to see the query explanation.

====

Timer

Memory

Peak Memory Use 18.25 MB

Message	Memory use
Component initialization	2.40 MB
Controller action start	3.58 MB
Controller render start	8.64 MB
View render complete	9.08 MB

Timers

Total Request Time: 241 (ms)

Message	Time in ms	Graph
Core Processing (Derived from $_SERVER["REQUEST_TIME"])	12.05
Event: Controller.initialize	0.34
Event: Controller.startup	0.62
Controller action	103.58
Event: Controller.beforeRender	50.14
» Processing toolbar data	49.98
Rendering View	3.40
» Event: View.beforeRender	0.03
» Rendering APP/View/Applications/view.ctp	0.47
» Event: View.afterRender	0.02
» Event: View.beforeLayout	0.02
» Rendering APP/View/Layouts/default.ctp	2.30
» » Rendering APP/View/Elements/google-analytics.ctp	0.23
Event: View.afterLayout	0.00

====

Log
+

Logs

There were no log entries made this request

====
Variables
+
View Variables
- application(array)
 Application(array)
 id125
 user_id29
 application_id(null)
 is_child0
 trial_status_id10
 total_sites5
 abstract_of_study sample
 study_title sample
 laymans_summary sample
 short_titleEt eius sit aut et fugiat adi
 protocol_noECCT/24/12/01
 reference_no(null)
 version_noDolorem veniam pariatur Consequat Numquam et digniss
 date_of_protocol01-12-2024
 study_drugId debitis rerum natus molestiae reprehenderit doloremque recusandae Ratione perspiciatis velit minim delectus similique suscipit fugiat
 disease_conditionTempor numquam voluptas amet aut tempore repellendus Magni pariatur
 product_type_biologicals0
 product_type_proteins0
 product_type_immunologicals1
 product_type_vaccines0
 product_type_hormones1
 product_type_toxoid0
 product_type_chemical0
 product_type_medical_device1
 product_type_chemical_nameStone Atkins
 product_type_medical_device_nameAnthony Lawrence
 comparatorNo
 comparator_nameSydnee Woods
 comparator_registeredEt sint officia eos asperiore
 comparator_countriesVel anim voluptatem
 ecct_not_applicable0
 ecct_ref_number
 email_addressjkiprotich@intellisoftkenya.com
 applicant_covering_letter1
 applicant_protocol1
 applicant_patient_information1
 applicant_investigators_brochure1
 applicant_investigators_cv1
 applicant_signed_declaration1
 applicant_financial_declaration1
 applicant_gmp_certificate1
 applicant_indemnity_cover1
 applicant_opinion_letter1
 applicant_approval_letter1
 applicant_statement1
 applicant_participating_countries(null)
 applicant_addendum1
 applicant_fees1
 applicant_complete_form(null)
 applicant_impd1
 applicant_prev_data1
 applicant_stability_data1
 applicant_analysis_cert1
 applicant_pictorial_sample1
 applicant_gcp_training1
 applicant_dsmb_charter1
 applicant_detailed_budget1
 applicant_indemnity_pi1
 applicant_practice_license1
 applicant_registration_ctr(null)
 applicant_pan_african1
 applicant_hard_copies(null)
 applicant_signed_checklist1
 statistical_analysis_plan1
 applicant_contractual_agreement1
 declaration_applicantQuo tenetur ex ut tempora consequatur rerum qui amet officiis sed molestiae fuga Quibusdam velit eu soluta voluptates amet
 declaration_date117-12-2024
 declaration_principal_investigatorSint explicabo Sint quos omnis quia aliquid non ullamco ipsum quia dignissimos qui et consequat Voluptatum cupidatat aut
 declaration_date217-12-2024
 placebo_presentYes
 study_objectives sample
 principal_inclusion_criteria sample
 principal_exclusion_criteria sample
 primary_end_points sample
 scope_diagnosis1
 scope_prophylaxis0
 scope_therapy0
 scope_safety1
 scope_efficacy0
 scope_pharmacokinetic0
 scope_pharmacodynamic1
 scope_bioequivalence0
 scope_dose_response0
 scope_pharmacogenetic0
 scope_pharmacogenomic1
 scope_pharmacoecomomic0
 scope_others0
 scope_others_specify
 trial_human_pharmacology0
 trial_administration_humans0
 trial_bioequivalence_study1
 trial_other0
 trial_other_specify
 trial_therapeutic_exploratory1
 trial_therapeutic_confirmatory0
 trial_therapeutic_use0
 design_controlledYes
 site_capacity(null)
 staff_numbers sample
 other_details_explanation sample
 other_details_regulatory_notapproved sample
 other_details_regulatory_approved sample
 other_details_regulatory_rejected sample
 other_details_regulatory_halted sample
 estimated_duration4
 design_controlled_randomisedNo
 design_controlled_openYes
 design_controlled_single_blindNo
 design_controlled_double_blindNo
 design_controlled_parallel_groupYes
 design_controlled_cross_overYes
 design_controlled_otherNo
 design_controlled_specify
 design_controlled_comparatorRecusandae Fuga Ut est
 design_controlled_other_medicinalYes
 design_controlled_placeboYes
 design_controlled_medicinal_otherNo
 design_controlled_medicinal_specify
 single_site_member_stateNo
 location_of_area
 single_site_physical_address
 single_site_contact_person
 single_site_telephone
 multiple_sites_member_stateYes
 multiple_countriesNo
 multiple_member_states
 number_of_sites543
 multi_country_list
 data_monitoring_committeeYes
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 content<h3 style="text-align: center;"> <img height="86" src="https://lh7-us.googleusercontent.com/eOWVvo3AHW74GguHveDaqdgy3YwNZqOqOO0QtscRoV4hJfcvt8Q6v4oLN3beVNvClvoD1ncu1RhB5D4iuAY-5R9h1aD2lEGqUorBVcQ0azfxsdvIz-WhbF3rA9-VQomtusnP2bNZTuYLFTC6vQ46nQ" style="background-color: transparent; color: rgb(0, 0, 0); font-family: "Bookman Old Style", serif; font-size: 11pt; white-space-collapse: preserve; margin-left: 0px; margin-top: 0px;" width="116" /></h3> MINISTRY OF HEALTH PHARMACY AND POISONS BOARD <table style="width: 100%; border:0px"> <tbody> <tr> <td style="width: 33.33%; border:0px"> <div id="left-editor"> Telegram: "MINHEALTH", Nairobi Cell phone: 0709 770 100 Email: info@pharmacyboardkenya.org Website: web.pharmacyboardkenya.org </div> </td> <td style="width: 33.33%;border:0px"> </td> <td style="width: 33.33%;border:0px"> <div id="right-editor"> Pharmacy and Poisons Board House Along Lenana Road P.O. Box 27663-00506 NAIROBI </div> </td> </tr> </tbody> </table> <address> </address> <address> When replying please quote</address> Ref. No. ECCT/24/12/01/2024(11) 17th December 2024 Lawrence Jennings Aladdin Powers Elton Delgado, Principal Investigator ECCT/24/12/01, Ut facere ea aliquam eveniet, Dear Sir/Madam, Re: ECCT/24/12/01 : Initial Approval; sample Et eius sit aut et fugiat adi. Reference is made to the above study. We acknowledge receipt of the following documents; <div style="margin-left: 15px;"> 1. GMP certificate of the investigational product from the site of manufacture <a href="http://45.79.161.190:8080/attachments/download/1071">screenshot_from_2024_11_28_11_17_15.png</a> dated 28th November 2024 Version 5 2. Cover Letter (Should list all the submitted documents, their version numbers and dates) <a href="http://45.79.161.190:8080/attachments/download/1118">logo_46.png</a> dated 1st December 2024 Version 1 3. The Study Protocol <a href="http://45.79.161.190:8080/attachments/download/1119">logo_47.png</a> dated 2nd December 2024 Version 3 4. Registration of the study at Pan African Clinical Trials Registry https://pactr.samrc.ac.za <a href="http://45.79.161.190:8080/attachments/download/1120">logo_48.png</a> dated 10th December 2024 Version 4 5. Patient Information leaflet and Informed consent form <a href="http://45.79.161.190:8080/attachments/download/1121">logo_49.png</a> dated 1st December 2024 Version 4 6. Investigators Brochure/Package inserts <a href="http://45.79.161.190:8080/attachments/download/1122">logo_50.png</a> dated 3rd December 2024 Version 3 7. Investigational Medicinal Product Dossier (IMPD) <a href="http://45.79.161.190:8080/attachments/download/1123">logo_51.png</a> dated 2nd December 2024 Version 3 8. Adequate data and information from previous studies and Phases to support carrying out of the current study <a href="http://45.79.161.190:8080/attachments/download/1124">logo_52.png</a> dated 2nd December 2024 Version 3 9. Stability data of the investigational product <a href="http://45.79.161.190:8080/attachments/download/1125">logo_53.png</a> dated 3rd December 2024 Version 3 10. Certificate of Analysis of the investigational product <a href="http://45.79.161.190:8080/attachments/download/1126">logo_54.png</a> dated 2nd December 2024 Version 4 11. Pictorial Sample of the investigational products. This sample should include the text of the labeling to be used <a href="http://45.79.161.190:8080/attachments/download/1127">logo_55.png</a> dated 3rd December 2024 Version 4 12. Signed investigator(s) CV(s) including that of study Pharmacist (NB: The CV should include the current workload of the Principal Investigator ) <a href="http://45.79.161.190:8080/attachments/download/1128">logo_56.png</a> dated 3rd December 2024 Version 4 13. Evidence of contractual agreement between sponsor and Principal Investigator. <a href="http://45.79.161.190:8080/attachments/download/1129">logo_57.png</a> dated 2nd December 2024 Version 4 14. DSMB Charter including the composition and meeting schedule <a href="http://45.79.161.190:8080/attachments/download/1130">logo_58.png</a> dated 2nd December 2024 Version 2 15. Evidence of recent GCP training of the core study staff <a href="http://45.79.161.190:8080/attachments/download/1131">logo_59.png</a> dated 4th December 2024 Version 6 16. Detailed budget of the study <a href="http://45.79.161.190:8080/attachments/download/1132">logo_60.png</a> dated 3rd December 2024 Version 4 17. Financial declaration by Sponsor and/or PI <a href="http://45.79.161.190:8080/attachments/download/1133">logo_61.png</a> dated 10th December 2024 Version 5 18. Signed Declaration by Sponsor or Principal investigator that the study will be carried out according to the protocol and applicable laws, regulations and GCP requirements. <a href="http://45.79.161.190:8080/attachments/download/1134">logo_62.png</a> dated 3rd December 2024 Version 3 19. Indemnity cover for PI, investigators and study Pharmacist. <a href="http://45.79.161.190:8080/attachments/download/1135">logo_63.png</a> dated 3rd December 2024 Version 5 20. Clinical Trials Insurance cover for study participants <a href="http://45.79.161.190:8080/attachments/download/1136">logo_64.png</a> dated 3rd December 2024 Version 2 21. Copy of current Practice Licenses for the Investigators and study Pharmacist <a href="http://45.79.161.190:8080/attachments/download/1137">logo_65.png</a> dated 2nd December 2024 Version 2 22. Copy of favorable opinion letter from the local Ethics Review Committee (ERC). <a href="http://45.79.161.190:8080/attachments/download/1138">logo_66.png</a> dated 3rd December 2024 Version 1 23. Copy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable <a href="http://45.79.161.190:8080/attachments/download/1139">logo_67.png</a> dated 2nd December 2024 Version 1 24. For multicentre/multi-site studies, a site specific addendum for each of the proposed sites including among other things the sites’ capacity to carry out the study i.e personnel, equipment, laboratory etc <a href="http://45.79.161.190:8080/attachments/download/1140">logo_68.png</a> dated 12th December 2024 Version 5 25. Statistical Analysis Plan <a href="http://45.79.161.190:8080/attachments/download/1141">logo_69.png</a> dated 2nd December 2024 Version 1 26. Signed Checklist <a href="http://45.79.161.190:8080/attachments/download/1142">logo_70.png</a> dated 2nd December 2024 Version 2 27. Payment of fees <a href="http://45.79.161.190:8080/attachments/download/1143">logo_71.png</a> dated 2nd December 2024 Version 9 28. A signed statement by the applicant indicating that all information contained in, or referenced by, the application is complete and accurate and is not false or misleading. <a href="http://45.79.161.190:8080/attachments/download/1144">logo_72.png</a> dated 13th December 2024 Version 2</div> After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials notes the following: :reviewer_summary_comments The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study: sample ECCT/24/12/01. This approval is valid for one year and in case the study extends beyond one year from the date of this letter, you are required to seek approval before proceeding with the study. The expiry date is 17th December 2025 <ol> <li> You should ensure compliance with Kenya Legal, regulatory and GCP requirements</li> <li> All safety reports should be submitted to ECCT as per the current PPB clinical trials guidelines</li> <li> It is your responsibility to inform the PPB of any changes to the protocol, research design and procedures that could introduce new or more than minimum risk to human subjects</li> <li> You are also reminded that upon conclusion of the study, you shall be required to submit the executive summary report of the study within 30 days while a copy of the clinical study report in ICH E3 format should be submitted to us within 180 days of the study closure</li> </ol> <div> Yours Sincerely, </div> :signature :approver For Chief Executive Officer 
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
 approvermanager
 approval_date17-12-2024
 expiry_date17-12-2025
 statusapproved
 deleted0
 deleted_date(null)
 created2024-12-17 09:52:14
 modified2025-01-06 10:28:11
 2(array)
 id12
 application_id125
 approval_noECCT/3/2024-ECCT/24/12/01
 type0
 content<h3 style="text-align: center;"> <img height="86" src="https://lh7-us.googleusercontent.com/eOWVvo3AHW74GguHveDaqdgy3YwNZqOqOO0QtscRoV4hJfcvt8Q6v4oLN3beVNvClvoD1ncu1RhB5D4iuAY-5R9h1aD2lEGqUorBVcQ0azfxsdvIz-WhbF3rA9-VQomtusnP2bNZTuYLFTC6vQ46nQ" style="background-color: transparent; color: rgb(0, 0, 0); font-family: "Bookman Old Style", serif; font-size: 11pt; white-space-collapse: preserve; margin-left: 0px; margin-top: 0px;" width="116" /></h3> MINISTRY OF HEALTH PHARMACY AND POISONS BOARD <table style="width: 100%; border:0px"> <tbody> <tr> <td style="width: 33.33%; border:0px"> <div id="left-editor"> Telegram: "MINHEALTH", Nairobi Cell phone: 0709 770 100 Email: info@pharmacyboardkenya.org Website: web.pharmacyboardkenya.org </div> </td> <td style="width: 33.33%;border:0px"> </td> <td style="width: 33.33%;border:0px"> <div id="right-editor"> Pharmacy and Poisons Board House Along Lenana Road P.O. Box 27663-00506 NAIROBI </div> </td> </tr> </tbody> </table> <address> </address> <address> When replying please quote</address> Ref. No. ECCT/3/2024-ECCT/24/12/01 17 Dec 2024 Lawrence Jennings Aladdin Powers Elton Delgado, Principal Investigator ECCT/24/12/01, Ut facere ea aliquam eveniet, Dear Sir/Madam, Re: ECCT/24/12/01 : Initial Approval; sample Et eius sit aut et fugiat adi. Reference is made to the above study. We acknowledge receipt of the following documents; <div style="margin-left: 15px;"> 1. GMP certificate of the investigational product from the site of manufacture <a href="/attachments/download/1071">screenshot_from_2024_11_28_11_17_15.png</a> dated 28th November 2024 Version 5 2. Cover Letter (Should list all the submitted documents, their version numbers and dates) <a href="/attachments/download/1118">logo_46.png</a> dated 1st December 2024 Version 1 3. The Study Protocol <a href="/attachments/download/1119">logo_47.png</a> dated 2nd December 2024 Version 3 4. Registration of the study at Pan African Clinical Trials Registry https://pactr.samrc.ac.za <a href="/attachments/download/1120">logo_48.png</a> dated 10th December 2024 Version 4 5. Patient Information leaflet and Informed consent form <a href="/attachments/download/1121">logo_49.png</a> dated 1st December 2024 Version 4 6. Investigators Brochure/Package inserts <a href="/attachments/download/1122">logo_50.png</a> dated 3rd December 2024 Version 3 7. Investigational Medicinal Product Dossier (IMPD) <a href="/attachments/download/1123">logo_51.png</a> dated 2nd December 2024 Version 3 8. Adequate data and information from previous studies and Phases to support carrying out of the current study <a href="/attachments/download/1124">logo_52.png</a> dated 2nd December 2024 Version 3 9. Stability data of the investigational product <a href="/attachments/download/1125">logo_53.png</a> dated 3rd December 2024 Version 3 10. Certificate of Analysis of the investigational product <a href="/attachments/download/1126">logo_54.png</a> dated 2nd December 2024 Version 4 11. Pictorial Sample of the investigational products. This sample should include the text of the labeling to be used <a href="/attachments/download/1127">logo_55.png</a> dated 3rd December 2024 Version 4 12. Signed investigator(s) CV(s) including that of study Pharmacist (NB: The CV should include the current workload of the Principal Investigator ) <a href="/attachments/download/1128">logo_56.png</a> dated 3rd December 2024 Version 4 13. Evidence of contractual agreement between sponsor and Principal Investigator. <a href="/attachments/download/1129">logo_57.png</a> dated 2nd December 2024 Version 4 14. DSMB Charter including the composition and meeting schedule <a href="/attachments/download/1130">logo_58.png</a> dated 2nd December 2024 Version 2 15. Evidence of recent GCP training of the core study staff <a href="/attachments/download/1131">logo_59.png</a> dated 4th December 2024 Version 6 16. Detailed budget of the study <a href="/attachments/download/1132">logo_60.png</a> dated 3rd December 2024 Version 4 17. Financial declaration by Sponsor and/or PI <a href="/attachments/download/1133">logo_61.png</a> dated 10th December 2024 Version 5 18. Signed Declaration by Sponsor or Principal investigator that the study will be carried out according to the protocol and applicable laws, regulations and GCP requirements. <a href="/attachments/download/1134">logo_62.png</a> dated 3rd December 2024 Version 3 19. Indemnity cover for PI, investigators and study Pharmacist. <a href="/attachments/download/1135">logo_63.png</a> dated 3rd December 2024 Version 5 20. Clinical Trials Insurance cover for study participants <a href="/attachments/download/1136">logo_64.png</a> dated 3rd December 2024 Version 2 21. Copy of current Practice Licenses for the Investigators and study Pharmacist <a href="/attachments/download/1137">logo_65.png</a> dated 2nd December 2024 Version 2 22. Copy of favorable opinion letter from the local Ethics Review Committee (ERC). <a href="/attachments/download/1138">logo_66.png</a> dated 3rd December 2024 Version 1 23. Copy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable <a href="/attachments/download/1139">logo_67.png</a> dated 2nd December 2024 Version 1 24. For multicentre/multi-site studies, a site specific addendum for each of the proposed sites including among other things the sites’ capacity to carry out the study i.e personnel, equipment, laboratory etc <a href="/attachments/download/1140">logo_68.png</a> dated 12th December 2024 Version 5 25. Statistical Analysis Plan <a href="/attachments/download/1141">logo_69.png</a> dated 2nd December 2024 Version 1 26. Signed Checklist <a href="/attachments/download/1142">logo_70.png</a> dated 2nd December 2024 Version 2 27. Payment of fees <a href="/attachments/download/1143">logo_71.png</a> dated 2nd December 2024 Version 9 28. A signed statement by the applicant indicating that all information contained in, or referenced by, the application is complete and accurate and is not false or misleading. <a href="/attachments/download/1144">logo_72.png</a> dated 13th December 2024 Version 2</div> After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials notes the following: The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study: sample ECCT/24/12/01. This approval is valid for one year and in case the study extends beyond one year from the date of this letter, you are required to seek approval before proceeding with the study. The expiry date is 17th December 2025 <ol> <li> You should ensure compliance with Kenya Legal, regulatory and GCP requirements</li> <li> All safety reports should be submitted to ECCT as per the current PPB clinical trials guidelines</li> <li> It is your responsibility to inform the PPB of any changes to the protocol, research design and procedures that could introduce new or more than minimum risk to human subjects</li> <li> You are also reminded that upon conclusion of the study, you shall be required to submit the executive summary report of the study within 30 days while a copy of the clinical study report in ICH E3 format should be submitted to us within 180 days of the study closure</li> </ol> <div> Yours Sincerely, </div> :signature :approver For Chief Executive Officer 
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 approvermanager
 approval_date17-12-2024
 expiry_date17-12-2025
 statusapproved
 deleted0
 deleted_date(null)
 created2024-12-17 09:52:27
 modified2024-12-17 09:53:09
 3(array)
 id16
 application_id125
 approval_noECCT/4/2024-ECCT/24/12/01
 type0
 content test test
 qrcode(null)
 approver(null)
 approval_date06-01-2025
 expiry_date06-01-2026
 statusapproved
 deleted0
 deleted_date(null)
 created2025-01-06 10:19:48
 modified2025-01-06 10:19:48
 4(array)
 id17
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 type0
 content<h3 style="text-align: center;"> <img height="86" src="https://lh7-us.googleusercontent.com/eOWVvo3AHW74GguHveDaqdgy3YwNZqOqOO0QtscRoV4hJfcvt8Q6v4oLN3beVNvClvoD1ncu1RhB5D4iuAY-5R9h1aD2lEGqUorBVcQ0azfxsdvIz-WhbF3rA9-VQomtusnP2bNZTuYLFTC6vQ46nQ" style="background-color: transparent; color: rgb(0, 0, 0); font-family: "Bookman Old Style", serif; font-size: 11pt; white-space-collapse: preserve; margin-left: 0px; margin-top: 0px;" width="116" /></h3> MINISTRY OF HEALTH PHARMACY AND POISONS BOARD <table style="width: 100%; border:0px"> <tbody> <tr> <td style="width: 33.33%; border:0px"> <div id="left-editor"> Telegram: "MINHEALTH", Nairobi Cell phone: 0709 770 100 Email: info@pharmacyboardkenya.org Website: web.pharmacyboardkenya.org </div> </td> <td style="width: 33.33%;border:0px"> </td> <td style="width: 33.33%;border:0px"> <div id="right-editor"> Pharmacy and Poisons Board House Along Lenana Road P.O. Box 27663-00506 NAIROBI </div> </td> </tr> </tbody> </table> <address> </address> <address> When replying please quote</address> Ref. No. ECCT/5/2024-ECCT/24/12/01 6 Jan 2025 Lawrence Jennings Aladdin Powers Elton Delgado, Principal Investigator ECCT/24/12/01, Ut facere ea aliquam eveniet, Dear Sir/Madam, Re: ECCT/24/12/01 : Initial Approval; sample Et eius sit aut et fugiat adi. Reference is made to the above study. We acknowledge receipt of the following documents; <div style="margin-left: 15px;"> 1. GMP certificate of the investigational product from the site of manufacture <a href="/attachments/download/1071">screenshot_from_2024_11_28_11_17_15.png</a> dated 28th November 2024 Version 5 2. Cover Letter (Should list all the submitted documents, their version numbers and dates) <a href="/attachments/download/1118">logo_46.png</a> dated 1st December 2024 Version 1 3. The Study Protocol <a href="/attachments/download/1119">logo_47.png</a> dated 2nd December 2024 Version 3 4. Registration of the study at Pan African Clinical Trials Registry https://pactr.samrc.ac.za <a href="/attachments/download/1120">logo_48.png</a> dated 10th December 2024 Version 4 5. Patient Information leaflet and Informed consent form <a href="/attachments/download/1121">logo_49.png</a> dated 1st December 2024 Version 4 6. Investigators Brochure/Package inserts <a href="/attachments/download/1122">logo_50.png</a> dated 3rd December 2024 Version 3 7. Investigational Medicinal Product Dossier (IMPD) <a href="/attachments/download/1123">logo_51.png</a> dated 2nd December 2024 Version 3 8. Adequate data and information from previous studies and Phases to support carrying out of the current study <a href="/attachments/download/1124">logo_52.png</a> dated 2nd December 2024 Version 3 9. Stability data of the investigational product <a href="/attachments/download/1125">logo_53.png</a> dated 3rd December 2024 Version 3 10. Certificate of Analysis of the investigational product <a href="/attachments/download/1126">logo_54.png</a> dated 2nd December 2024 Version 4 11. Pictorial Sample of the investigational products. This sample should include the text of the labeling to be used <a href="/attachments/download/1127">logo_55.png</a> dated 3rd December 2024 Version 4 12. Signed investigator(s) CV(s) including that of study Pharmacist (NB: The CV should include the current workload of the Principal Investigator ) <a href="/attachments/download/1128">logo_56.png</a> dated 3rd December 2024 Version 4 13. Evidence of contractual agreement between sponsor and Principal Investigator. <a href="/attachments/download/1129">logo_57.png</a> dated 2nd December 2024 Version 4 14. DSMB Charter including the composition and meeting schedule <a href="/attachments/download/1130">logo_58.png</a> dated 2nd December 2024 Version 2 15. Evidence of recent GCP training of the core study staff <a href="/attachments/download/1131">logo_59.png</a> dated 4th December 2024 Version 6 16. Detailed budget of the study <a href="/attachments/download/1132">logo_60.png</a> dated 3rd December 2024 Version 4 17. Financial declaration by Sponsor and/or PI <a href="/attachments/download/1133">logo_61.png</a> dated 10th December 2024 Version 5 18. Signed Declaration by Sponsor or Principal investigator that the study will be carried out according to the protocol and applicable laws, regulations and GCP requirements. <a href="/attachments/download/1134">logo_62.png</a> dated 3rd December 2024 Version 3 19. Indemnity cover for PI, investigators and study Pharmacist. <a href="/attachments/download/1135">logo_63.png</a> dated 3rd December 2024 Version 5 20. Clinical Trials Insurance cover for study participants <a href="/attachments/download/1136">logo_64.png</a> dated 3rd December 2024 Version 2 21. Copy of current Practice Licenses for the Investigators and study Pharmacist <a href="/attachments/download/1137">logo_65.png</a> dated 2nd December 2024 Version 2 22. Copy of favorable opinion letter from the local Ethics Review Committee (ERC). <a href="/attachments/download/1138">logo_66.png</a> dated 3rd December 2024 Version 1 23. Copy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable <a href="/attachments/download/1139">logo_67.png</a> dated 2nd December 2024 Version 1 24. For multicentre/multi-site studies, a site specific addendum for each of the proposed sites including among other things the sites’ capacity to carry out the study i.e personnel, equipment, laboratory etc <a href="/attachments/download/1140">logo_68.png</a> dated 12th December 2024 Version 5 25. Statistical Analysis Plan <a href="/attachments/download/1141">logo_69.png</a> dated 2nd December 2024 Version 1 26. Signed Checklist <a href="/attachments/download/1142">logo_70.png</a> dated 2nd December 2024 Version 2 27. Payment of fees <a href="/attachments/download/1143">logo_71.png</a> dated 2nd December 2024 Version 9 28. A signed statement by the applicant indicating that all information contained in, or referenced by, the application is complete and accurate and is not false or misleading. <a href="/attachments/download/1144">logo_72.png</a> dated 13th December 2024 Version 2</div> After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials notes the following: 1.1 Introduction Maiores porro natus Primary pharmacodynamics comments Voluptatibus non cup Secondary pharmacodynamics comments Tenetur cillum ut nu Pharmacodynamic drug interactions comments Magni perferendis iu Pharmacokinetics comments Dolorum amet assume Absorption, Distribution, Metabolism & Excretion comments Qui eaque occaecat m Other pharmacokinetic studies comments Quaerat laboris dign Animal species selection/Study design comments Minim amet ea offic Single dose toxicity comments Voluptatem deleniti Repeat-dose toxicity comments Magnam omnis est des Genotoxicity comments Possimus sint tempo Carcinogenicity comments Repellendus Dolor i Reproductive and developmental toxicity - comments Officia dolore sit Juvenile toxicity studies comments Et aliqua Do eum qu Other studies (including enhanced PPND studies) comments Aut natus quibusdam Local tolerance comments Atque nostrum laboru Other toxicity studies comments Nostrud itaque volup Additional Considerations comments Quam eius rerum quia GLP aspects comments Voluptatibus in ex f Overall comment/ conclusion on the non-clinical assessment Eius sint ut debitis The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study: sample ECCT/24/12/01. This approval is valid for one year and in case the study extends beyond one year from the date of this letter, you are required to seek approval before proceeding with the study. The expiry date is 17th December 2025 <ol> <li> You should ensure compliance with Kenya Legal, regulatory and GCP requirements</li> <li> All safety reports should be submitted to ECCT as per the current PPB clinical trials guidelines</li> <li> It is your responsibility to inform the PPB of any changes to the protocol, research design and procedures that could introduce new or more than minimum risk to human subjects</li> <li> You are also reminded that upon conclusion of the study, you shall be required to submit the executive summary report of the study within 30 days while a copy of the clinical study report in ICH E3 format should be submitted to us within 180 days of the study closure</li> </ol> <div> Yours Sincerely, </div> :signature :approver For Chief Executive Officer 
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 approvermanager
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 expiry_date06-01-2026
 statusapproved
 deleted0
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 created2025-01-06 10:24:02
 modified2025-01-06 10:24:21
 5(array)
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 application_id125
 approval_noECCT/6/2024-ECCT/24/12/01
 type0
 content<h3 style="text-align: center;"> <img height="86" src="https://lh7-us.googleusercontent.com/eOWVvo3AHW74GguHveDaqdgy3YwNZqOqOO0QtscRoV4hJfcvt8Q6v4oLN3beVNvClvoD1ncu1RhB5D4iuAY-5R9h1aD2lEGqUorBVcQ0azfxsdvIz-WhbF3rA9-VQomtusnP2bNZTuYLFTC6vQ46nQ" style="background-color: transparent; color: rgb(0, 0, 0); font-family: "Bookman Old Style", serif; font-size: 11pt; white-space-collapse: preserve; margin-left: 0px; margin-top: 0px;" width="116" /></h3> MINISTRY OF HEALTH PHARMACY AND POISONS BOARD <table style="width: 100%; border:0px"> <tbody> <tr> <td style="width: 33.33%; border:0px"> <div id="left-editor"> Telegram: "MINHEALTH", Nairobi Cell phone: 0709 770 100 Email: info@pharmacyboardkenya.org Website: web.pharmacyboardkenya.org </div> </td> <td style="width: 33.33%;border:0px"> </td> <td style="width: 33.33%;border:0px"> <div id="right-editor"> Pharmacy and Poisons Board House Along Lenana Road P.O. Box 27663-00506 NAIROBI </div> </td> </tr> </tbody> </table> <address> </address> <address> When replying please quote</address> Ref. No. ECCT/6/2024-ECCT/24/12/01 6 Jan 2025 Lawrence Jennings Aladdin Powers Elton Delgado, Principal Investigator ECCT/24/12/01, Ut facere ea aliquam eveniet, Dear Sir/Madam, Re: ECCT/24/12/01 : Annual Approval; sample Et eius sit aut et fugiat adi. Reference is made to the above study. We acknowledge receipt of the following documents; <div style="margin-left: 15px;"> </div> After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials notes the following: 1.1 Introduction Maiores porro natus Primary pharmacodynamics comments Voluptatibus non cup Secondary pharmacodynamics comments Tenetur cillum ut nu Pharmacodynamic drug interactions comments Magni perferendis iu Pharmacokinetics comments Dolorum amet assume Absorption, Distribution, Metabolism & Excretion comments Qui eaque occaecat m Other pharmacokinetic studies comments Quaerat laboris dign Animal species selection/Study design comments Minim amet ea offic Single dose toxicity comments Voluptatem deleniti Repeat-dose toxicity comments Magnam omnis est des Genotoxicity comments Possimus sint tempo Carcinogenicity comments Repellendus Dolor i Reproductive and developmental toxicity - comments Officia dolore sit Juvenile toxicity studies comments Et aliqua Do eum qu Other studies (including enhanced PPND studies) comments Aut natus quibusdam Local tolerance comments Atque nostrum laboru Other toxicity studies comments Nostrud itaque volup Additional Considerations comments Quam eius rerum quia GLP aspects comments Voluptatibus in ex f Overall comment/ conclusion on the non-clinical assessment Eius sint ut debitis The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study: sample ECCT/24/12/01. This approval is valid for one year and in case the study extends beyond one year from the date of this letter, you are required to seek approval before proceeding with the study. The expiry date is 6th January 2026 <ol> <li> You should ensure compliance with Kenya Legal, regulatory and GCP requirements</li> <li> All safety reports should be submitted to ECCT as per the current PPB clinical trials guidelines</li> <li> It is your responsibility to inform the PPB of any changes to the protocol, research design and procedures that could introduce new or more than minimum risk to human subjects</li> <li> You are also reminded that upon conclusion of the study, you shall be required to submit the executive summary report of the study within 30 days while a copy of the clinical study report in ICH E3 format should be submitted to us within 180 days of the study closure</li> </ol> <div> Yours Sincerely, </div> :signature :approver For Chief Executive Officer 
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 content<h3 style="text-align: center;"> <img height="86" src="https://lh7-us.googleusercontent.com/eOWVvo3AHW74GguHveDaqdgy3YwNZqOqOO0QtscRoV4hJfcvt8Q6v4oLN3beVNvClvoD1ncu1RhB5D4iuAY-5R9h1aD2lEGqUorBVcQ0azfxsdvIz-WhbF3rA9-VQomtusnP2bNZTuYLFTC6vQ46nQ" style="background-color: transparent; color: rgb(0, 0, 0); font-family: "Bookman Old Style", serif; font-size: 11pt; white-space-collapse: preserve; margin-left: 0px; margin-top: 0px;" width="116" /></h3> MINISTRY OF HEALTH PHARMACY AND POISONS BOARD <table style="width: 100%; border:0px"> <tbody> <tr> <td style="width: 33.33%; border:0px"> <div id="left-editor"> Telegram: "MINHEALTH", Nairobi Cell phone: 0709 770 100 Email: info@pharmacyboardkenya.org Website: web.pharmacyboardkenya.org </div> </td> <td style="width: 33.33%;border:0px"> </td> <td style="width: 33.33%;border:0px"> <div id="right-editor"> Pharmacy and Poisons Board House Along Lenana Road P.O. Box 27663-00506 NAIROBI </div> </td> </tr> </tbody> </table> <address> </address> <address> When replying please quote</address> Ref. No. ECCT/7/2024-ECCT/24/12/01 7 Jan 2025 Lawrence Jennings Aladdin Powers Elton Delgado, Principal Investigator ECCT/24/12/01, Ut facere ea aliquam eveniet, Dear Sir/Madam, Re: ECCT/24/12/01 : Annual Approval; sample Et eius sit aut et fugiat adi. Reference is made to the above study. We acknowledge receipt of the following documents; <div style="margin-left: 15px;"> 1. Cover Letter (Should list all the submitted documents, their version numbers and dates) <a href="/attachments/download/1185">logo_is_b.jpg</a> dated 9th January 2025 Version 2. Annual progress report <a href="/attachments/download/1186">logo_is_b_2.jpg</a> dated 1st January 2025 Version 3. SAE and SUSAR cumulative logs <a href="/attachments/download/1187">logo_is_b_3.jpg</a> dated 8th January 2025 Version 5 4. Latest Data Safety Monitoring Board (DSMB) report <a href="/attachments/download/1188">logo_is_b_4.jpg</a> dated 6th January 2025 Version 6 5. Protocol Violations and Protocol Deviations logs <a href="/attachments/download/1189">logo_is_b_5.jpg</a> dated 1st January 1970 Version 6. Updated Investigators Brochure/Package inserts or Investigational Medicinal Product Dossier (IMPD) <a href="/attachments/download/1190">logo_is_b_6.jpg</a> dated 30th December 2024 Version 6 7. The Development Safety Update Report (DSUR) <a href="/attachments/download/1191">logo_is_b_7.jpg</a> dated 1st January 1970 Version 8. Copy of current favourable opinion letter from the local Ethics Review Committee (ERC). <a href="/attachments/download/1192">logo_is_b_8.jpg</a> dated 1st January 1970 Version 9. Copy of the Annual Practice License of the Investigators <a href="/attachments/download/1193">logo_is_b_9.jpg</a> dated 1st January 1970 Version 10. Copy of the Annual Practice License for the Pharmacist <a href="/attachments/download/1194">logo_is_b_10.jpg</a> dated 1st January 1970 Version 11. Copy of the valid professional indemnity insurance cover for the investigators <a href="/attachments/download/1195">logo_is_b_11.jpg</a> dated 1st January 1970 Version 12. Copy of the valid professional indemnity insurance cover for the study pharmacist <a href="/attachments/download/1196">logo_is_b_12.jpg</a> dated 1st January 1970 Version 13. Copy of valid participants’ clinical trials insurance cover <a href="/attachments/download/1197">logo_is_b_13.jpg</a> dated 1st January 1970 Version 14. Evidence of registration of the study at Pan African Clinical Trials Registry https://pactr.samrc.ac.za <a href="/attachments/download/1198">logo_is_b_14.jpg</a> dated 1st January 1970 Version 15. A signed checklist confirming the submission of the document <a href="/attachments/download/1199">logo_is_b_15.jpg</a> dated 1st January 1970 Version </div> After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials notes the following: 1.1 Introduction Maiores porro natus Primary pharmacodynamics comments Voluptatibus non cup Secondary pharmacodynamics comments Tenetur cillum ut nu Pharmacodynamic drug interactions comments Magni perferendis iu Pharmacokinetics comments Dolorum amet assume Absorption, Distribution, Metabolism & Excretion comments Qui eaque occaecat m Other pharmacokinetic studies comments Quaerat laboris dign Animal species selection/Study design comments Minim amet ea offic Single dose toxicity comments Voluptatem deleniti Repeat-dose toxicity comments Magnam omnis est des Genotoxicity comments Possimus sint tempo Carcinogenicity comments Repellendus Dolor i Reproductive and developmental toxicity - comments Officia dolore sit Juvenile toxicity studies comments Et aliqua Do eum qu Other studies (including enhanced PPND studies) comments Aut natus quibusdam Local tolerance comments Atque nostrum laboru Other toxicity studies comments Nostrud itaque volup Additional Considerations comments Quam eius rerum quia GLP aspects comments Voluptatibus in ex f Overall comment/ conclusion on the non-clinical assessment Eius sint ut debitis The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study: sample ECCT/24/12/01. This approval is valid for one year and in case the study extends beyond one year from the date of this letter, you are required to seek approval before proceeding with the study. The expiry date is 7th January 2026 <ol> <li> You should ensure compliance with Kenya Legal, regulatory and GCP requirements</li> <li> All safety reports should be submitted to ECCT as per the current PPB clinical trials guidelines</li> <li> It is your responsibility to inform the PPB of any changes to the protocol, research design and procedures that could introduce new or more than minimum risk to human subjects</li> <li> You are also reminded that upon conclusion of the study, you shall be required to submit the executive summary report of the study within 30 days while a copy of the clinical study report in ICH E3 format should be submitted to us within 180 days of the study closure</li> </ol> <div> Yours Sincerely, </div> :signature :approver For Chief Executive Officer 
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 content<h3 style="text-align: center;"> <img height="86" src="https://lh7-us.googleusercontent.com/eOWVvo3AHW74GguHveDaqdgy3YwNZqOqOO0QtscRoV4hJfcvt8Q6v4oLN3beVNvClvoD1ncu1RhB5D4iuAY-5R9h1aD2lEGqUorBVcQ0azfxsdvIz-WhbF3rA9-VQomtusnP2bNZTuYLFTC6vQ46nQ" style="background-color: transparent; color: rgb(0, 0, 0); font-family: "Bookman Old Style", serif; font-size: 11pt; white-space-collapse: preserve; margin-left: 0px; margin-top: 0px;" width="116" /></h3> MINISTRY OF HEALTH PHARMACY AND POISONS BOARD <table style="width: 100%; border:0px"> <tbody> <tr> <td style="width: 33.33%; border:0px"> <div id="left-editor"> Telegram: "MINHEALTH", Nairobi Cell phone: 0709 770 100 Email: info@pharmacyboardkenya.org Website: web.pharmacyboardkenya.org </div> </td> <td style="width: 33.33%;border:0px"> </td> <td style="width: 33.33%;border:0px"> <div id="right-editor"> Pharmacy and Poisons Board House Along Lenana Road P.O. Box 27663-00506 NAIROBI </div> </td> </tr> </tbody> </table> <address> </address> <address> When replying please quote</address> Ref. No. ECCT/8/2024-ECCT/24/12/01 7 Jan 2025 Lawrence Jennings Aladdin Powers Elton Delgado, Principal Investigator ECCT/24/12/01, Ut facere ea aliquam eveniet, Dear Sir/Madam, Re: ECCT/24/12/01 : Annual Approval; sample Et eius sit aut et fugiat adi. Reference is made to the above study. We acknowledge receipt of the following documents; <div style="margin-left: 15px;"> 1. Cover Letter (Should list all the submitted documents, their version numbers and dates) <a href="/attachments/download/1185">logo_is_b.jpg</a> dated 9th January 2025 Version 2. Annual progress report <a href="/attachments/download/1186">logo_is_b_2.jpg</a> dated 1st January 2025 Version 3. SAE and SUSAR cumulative logs <a href="/attachments/download/1187">logo_is_b_3.jpg</a> dated 8th January 2025 Version 5 4. Latest Data Safety Monitoring Board (DSMB) report <a href="/attachments/download/1188">logo_is_b_4.jpg</a> dated 6th January 2025 Version 6 5. Protocol Violations and Protocol Deviations logs <a href="/attachments/download/1189">logo_is_b_5.jpg</a> dated 1st January 1970 Version 6. Updated Investigators Brochure/Package inserts or Investigational Medicinal Product Dossier (IMPD) <a href="/attachments/download/1190">logo_is_b_6.jpg</a> dated 30th December 2024 Version 6 7. The Development Safety Update Report (DSUR) <a href="/attachments/download/1191">logo_is_b_7.jpg</a> dated 1st January 1970 Version 8. Copy of current favourable opinion letter from the local Ethics Review Committee (ERC). <a href="/attachments/download/1192">logo_is_b_8.jpg</a> dated 1st January 1970 Version 9. Copy of the Annual Practice License of the Investigators <a href="/attachments/download/1193">logo_is_b_9.jpg</a> dated 1st January 1970 Version 10. Copy of the Annual Practice License for the Pharmacist <a href="/attachments/download/1194">logo_is_b_10.jpg</a> dated 1st January 1970 Version 11. Copy of the valid professional indemnity insurance cover for the investigators <a href="/attachments/download/1195">logo_is_b_11.jpg</a> dated 1st January 1970 Version 12. Copy of the valid professional indemnity insurance cover for the study pharmacist <a href="/attachments/download/1196">logo_is_b_12.jpg</a> dated 1st January 1970 Version 13. Copy of valid participants’ clinical trials insurance cover <a href="/attachments/download/1197">logo_is_b_13.jpg</a> dated 1st January 1970 Version 14. Evidence of registration of the study at Pan African Clinical Trials Registry https://pactr.samrc.ac.za <a href="/attachments/download/1198">logo_is_b_14.jpg</a> dated 1st January 1970 Version 15. A signed checklist confirming the submission of the document <a href="/attachments/download/1199">logo_is_b_15.jpg</a> dated 1st January 1970 Version </div> After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials notes the following: 1.1 Introduction Maiores porro natus Primary pharmacodynamics comments Voluptatibus non cup Secondary pharmacodynamics comments Tenetur cillum ut nu Pharmacodynamic drug interactions comments Magni perferendis iu Pharmacokinetics comments Dolorum amet assume Absorption, Distribution, Metabolism & Excretion comments Qui eaque occaecat m Other pharmacokinetic studies comments Quaerat laboris dign Animal species selection/Study design comments Minim amet ea offic Single dose toxicity comments Voluptatem deleniti Repeat-dose toxicity comments Magnam omnis est des Genotoxicity comments Possimus sint tempo Carcinogenicity comments Repellendus Dolor i Reproductive and developmental toxicity - comments Officia dolore sit Juvenile toxicity studies comments Et aliqua Do eum qu Other studies (including enhanced PPND studies) comments Aut natus quibusdam Local tolerance comments Atque nostrum laboru Other toxicity studies comments Nostrud itaque volup Additional Considerations comments Quam eius rerum quia GLP aspects comments Voluptatibus in ex f Overall comment/ conclusion on the non-clinical assessment Eius sint ut debitis Trial category workspace Fugit obcaecati et Trial category comments Enim consequatur con Trial phase workspace Dolor dolore fuga S Trial phase comments (if in disagreement with the study phase proposed): Et debitis earum dol Therapeutic condition workspace A praesentium aut od Brief description of the disease Molestias ut aut non Brief discussion of clinical pharmacokinetic data, efficacy and safety data described in the IB from previous trials /previously investigated indications(s) for the IMP(s). Non-clinical studies may also be discussed for early or FIH clinical trials. Consideration should be given to the justification provided based on the non-clinical data, for the proposed starting dose, dose steps, and maximum exposure Anim totam molestiae Assessor’s discussion on the clinical development: Dignissimos ut qui d Consider what is new in this trial, the clinical relevance, and the medical need that the trial aims to address Illo cumque perferen Clinical Trial Rationale comments Qui quo eiusmod volu Consider if there are established primary endpoints for this type of study/indication, do they match the goals, are they validated? Consectetur et maxi Primary objectives comments Debitis sunt qui nis Secondary objectives workspace Atque nihil ea et re Secondary objectives comments Recusandae Magnam f Study population workspace Aut perferendis et q Study population comments A molestiae fugit i Take also into consideration the gender and age allocation of participants, and determine whether a specific group is excluded or underrepresented Incididunt Nam numqu Inclusion criteria comments Ea qui velit sint e Check if a justification is provided in the event that a specific group is excluded or underrepresented Applicable for registered products, consider the contraindications included in the SmPC for the investigational medical product, comparator, and auxiliary medical products Architecto molestias Exclusion criteria comments Voluptatem est id The inclusion of vulnerable population is justifiable only if this information cannot be obtained from non‑vulnerable populations For incapacitated or minor participants, the trial should offer some direct benefit to the tem or to the population that they represent Ducimus ducimus mo Vulnerable populations comments Ad velit autem aut l Brief description of the study plan and design, and whenever possible, include a diagram/flow chart Discuss the expected duration of the participants' participation and a description of the sequence and duration of all the clinical trial periods, including the follow up Harum ut alias repre Study plan and design comments Sed illo qui ea quo Consider the dose(s)/dose steps, dose rationale, route of administration, schedule, treatment duration, and dose modifications Aspernatur iste quia Study treatment comments Eum dolor consequatu Comparator IMP(s) workspace Quas sint voluptatem Comparator IMP(s) comments Do aliquip quidem qu Placebo workspace Expedita et laborios Placebo comments Voluptate cupiditate Auxilliary medicinal product(s) workspace Eu sit corporis et a Auxilliary medicinal product(s) comments In sunt asperiores d Additional considerations workspace Perferendis sint qui Additional considerations comments Ea doloremque duis e Brief description of the important safety risks associated with trial treatments identified in any previous clinical trials, and as outlined in the IB or SmPC, or from another source Nesciunt velit anim Safety comments Fugiat sunt occaeca Blinding and unblinding workspace Et ab quia id proide Blinding and unblinding comments Eum suscipit omnis r Contraception measures workspace Ea consequatur Nobi Contraception measures comments Tempor id id facere Discontinuation criteria workspace Natus incidunt qui Discontinuation criteria comments Facilis eos earum q Other concomitant workspace Quo libero est tene Other concomitant comments Delectus minima qua Safety and Monitoring workspace Sunt provident eum Safety and Monitoring comments Velit numquam dolore Reference Safety Information workspace Ratione dignissimos Reference Safety Information comments Quasi cum dolores po Data Safety Monitoring Committee workspace Aliquid adipisci mai Data Safety Monitoring Committee comments Velit nemo dolor odi Definition of the end of the trial workspace Odio minima neque ap Definition of the end of the trial comments Sed quia adipisci do Biological samples used in the study workspace Enim esse ex est e Biological samples used in the study comments Officiis et delectus Data protection workspace Autem repellendus E Data protection comments Consequat Rem sit s Recruitment and informed consent procedures workspace Tempor incidunt fac Recruitment and informed consent procedures comment Rerum tenetur expedi Benefit/risk assessment workspace Sint iusto facilis Comments on the benefit/risk: Inventore provident Assessor’s overall conclusions workspace Do ducimus necessit Overall comment/ conclusion on the clinical assessment: Doloremque rerum vol 1.5.1 REQUESTS FOR ADDITIONAL INFORMATION Neque minus vel veni Study plan and design workspace Ad in dolor id deser Study plan and design comments Mollit et aspernatur Randomization and blinding workspace Nemo quasi elit dol Randomization and blinding comments Expedita maiores vit Sample size, trial power and level of significance used workspace Optio nobis nostrum Sample size, trial power and level of significance used comments Exercitation deserun Planned analysis workspace Eum odio sint iure v Planned analysis comments Iusto esse ut repre Interim analysis workspace Enim dolor deleniti Interim analysis comments Iusto qui fugiat qui Assessor’s Overall Conclusion on the Statistical Part workspace Consectetur magni ve Assessor’s Overall Conclusion on the Statistical Part comments Laboris magna id es The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study: sample ECCT/24/12/01. This approval is valid for one year and in case the study extends beyond one year from the date of this letter, you are required to seek approval before proceeding with the study. The expiry date is 7th January 2026 <ol> <li> You should ensure compliance with Kenya Legal, regulatory and GCP requirements</li> <li> All safety reports should be submitted to ECCT as per the current PPB clinical trials guidelines</li> <li> It is your responsibility to inform the PPB of any changes to the protocol, research design and procedures that could introduce new or more than minimum risk to human subjects</li> <li> You are also reminded that upon conclusion of the study, you shall be required to submit the executive summary report of the study within 30 days while a copy of the clinical study report in ICH E3 format should be submitted to us within 180 days of the study closure</li> </ol> <div> Yours Sincerely, </div> :signature :approver For Chief Executive Officer 
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 content<h3 style="text-align: center;"> <img height="86" src="https://lh7-us.googleusercontent.com/eOWVvo3AHW74GguHveDaqdgy3YwNZqOqOO0QtscRoV4hJfcvt8Q6v4oLN3beVNvClvoD1ncu1RhB5D4iuAY-5R9h1aD2lEGqUorBVcQ0azfxsdvIz-WhbF3rA9-VQomtusnP2bNZTuYLFTC6vQ46nQ" style="background-color: transparent; color: rgb(0, 0, 0); font-family: "Bookman Old Style", serif; font-size: 11pt; white-space-collapse: preserve; margin-left: 0px; margin-top: 0px;" width="116" /></h3> MINISTRY OF HEALTH PHARMACY AND POISONS BOARD <table style="width: 100%; border:0px"> <tbody> <tr> <td style="width: 33.33%; border:0px"> <div id="left-editor"> Telegram: "MINHEALTH", Nairobi Cell phone: 0709 770 100 Email: info@pharmacyboardkenya.org Website: web.pharmacyboardkenya.org </div> </td> <td style="width: 33.33%;border:0px"> </td> <td style="width: 33.33%;border:0px"> <div id="right-editor"> Pharmacy and Poisons Board House Along Lenana Road P.O. Box 27663-00506 NAIROBI </div> </td> </tr> </tbody> </table> <address> </address> <address> When replying please quote</address> Ref. No. ECCT/9/2024-ECCT/24/12/01 7 Jan 2025 Lawrence Jennings Aladdin Powers Elton Delgado, Principal Investigator ECCT/24/12/01, Ut facere ea aliquam eveniet, Dear Sir/Madam, Re: ECCT/24/12/01 : Initial Approval; sample Et eius sit aut et fugiat adi. Reference is made to the above study. We acknowledge receipt of the following documents; <div style="margin-left: 15px;"> 1. GMP certificate of the investigational product from the site of manufacture <a href="/attachments/download/1071">screenshot_from_2024_11_28_11_17_15.png</a> dated 28th November 2024 Version 5 2. Cover Letter (Should list all the submitted documents, their version numbers and dates) <a href="/attachments/download/1118">logo_46.png</a> dated 1st December 2024 Version 1 3. The Study Protocol <a href="/attachments/download/1119">logo_47.png</a> dated 2nd December 2024 Version 3 4. Registration of the study at Pan African Clinical Trials Registry https://pactr.samrc.ac.za <a href="/attachments/download/1120">logo_48.png</a> dated 10th December 2024 Version 4 5. Patient Information leaflet and Informed consent form <a href="/attachments/download/1121">logo_49.png</a> dated 1st December 2024 Version 4 6. Investigators Brochure/Package inserts <a href="/attachments/download/1122">logo_50.png</a> dated 3rd December 2024 Version 3 7. Investigational Medicinal Product Dossier (IMPD) <a href="/attachments/download/1123">logo_51.png</a> dated 2nd December 2024 Version 3 8. Adequate data and information from previous studies and Phases to support carrying out of the current study <a href="/attachments/download/1124">logo_52.png</a> dated 2nd December 2024 Version 3 9. Stability data of the investigational product <a href="/attachments/download/1125">logo_53.png</a> dated 3rd December 2024 Version 3 10. Certificate of Analysis of the investigational product <a href="/attachments/download/1126">logo_54.png</a> dated 2nd December 2024 Version 4 11. Pictorial Sample of the investigational products. This sample should include the text of the labeling to be used <a href="/attachments/download/1127">logo_55.png</a> dated 3rd December 2024 Version 4 12. Signed investigator(s) CV(s) including that of study Pharmacist (NB: The CV should include the current workload of the Principal Investigator ) <a href="/attachments/download/1128">logo_56.png</a> dated 3rd December 2024 Version 4 13. Evidence of contractual agreement between sponsor and Principal Investigator. <a href="/attachments/download/1129">logo_57.png</a> dated 2nd December 2024 Version 4 14. DSMB Charter including the composition and meeting schedule <a href="/attachments/download/1130">logo_58.png</a> dated 2nd December 2024 Version 2 15. Evidence of recent GCP training of the core study staff <a href="/attachments/download/1131">logo_59.png</a> dated 4th December 2024 Version 6 16. Detailed budget of the study <a href="/attachments/download/1132">logo_60.png</a> dated 3rd December 2024 Version 4 17. Financial declaration by Sponsor and/or PI <a href="/attachments/download/1133">logo_61.png</a> dated 10th December 2024 Version 5 18. Signed Declaration by Sponsor or Principal investigator that the study will be carried out according to the protocol and applicable laws, regulations and GCP requirements. <a href="/attachments/download/1134">logo_62.png</a> dated 3rd December 2024 Version 3 19. Indemnity cover for PI, investigators and study Pharmacist. <a href="/attachments/download/1135">logo_63.png</a> dated 3rd December 2024 Version 5 20. Clinical Trials Insurance cover for study participants <a href="/attachments/download/1136">logo_64.png</a> dated 3rd December 2024 Version 2 21. Copy of current Practice Licenses for the Investigators and study Pharmacist <a href="/attachments/download/1137">logo_65.png</a> dated 2nd December 2024 Version 2 22. Copy of favorable opinion letter from the local Ethics Review Committee (ERC). <a href="/attachments/download/1138">logo_66.png</a> dated 3rd December 2024 Version 1 23. Copy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable <a href="/attachments/download/1139">logo_67.png</a> dated 2nd December 2024 Version 1 24. For multicentre/multi-site studies, a site specific addendum for each of the proposed sites including among other things the sites’ capacity to carry out the study i.e personnel, equipment, laboratory etc <a href="/attachments/download/1140">logo_68.png</a> dated 12th December 2024 Version 5 25. Statistical Analysis Plan <a href="/attachments/download/1141">logo_69.png</a> dated 2nd December 2024 Version 1 26. Signed Checklist <a href="/attachments/download/1142">logo_70.png</a> dated 2nd December 2024 Version 2 27. Payment of fees <a href="/attachments/download/1143">logo_71.png</a> dated 2nd December 2024 Version 9 28. A signed statement by the applicant indicating that all information contained in, or referenced by, the application is complete and accurate and is not false or misleading. <a href="/attachments/download/1144">logo_72.png</a> dated 13th December 2024 Version 2 </div> After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials notes the following: 1.1 Introduction Maiores porro natus Primary pharmacodynamics comments Voluptatibus non cup Secondary pharmacodynamics comments Tenetur cillum ut nu Pharmacodynamic drug interactions comments Magni perferendis iu Pharmacokinetics comments Dolorum amet assume Absorption, Distribution, Metabolism & Excretion comments Qui eaque occaecat m Other pharmacokinetic studies comments Quaerat laboris dign Animal species selection/Study design comments Minim amet ea offic Single dose toxicity comments Voluptatem deleniti Repeat-dose toxicity comments Magnam omnis est des Genotoxicity comments Possimus sint tempo Carcinogenicity comments Repellendus Dolor i Reproductive and developmental toxicity - comments Officia dolore sit Juvenile toxicity studies comments Et aliqua Do eum qu Other studies (including enhanced PPND studies) comments Aut natus quibusdam Local tolerance comments Atque nostrum laboru Other toxicity studies comments Nostrud itaque volup Additional Considerations comments Quam eius rerum quia GLP aspects comments Voluptatibus in ex f Overall comment/ conclusion on the non-clinical assessment Eius sint ut debitis Trial category workspace Fugit obcaecati et Trial category comments Enim consequatur con Trial phase workspace Dolor dolore fuga S Trial phase comments (if in disagreement with the study phase proposed): Et debitis earum dol Therapeutic condition workspace A praesentium aut od Brief description of the disease Molestias ut aut non Brief discussion of clinical pharmacokinetic data, efficacy and safety data described in the IB from previous trials /previously investigated indications(s) for the IMP(s). Non-clinical studies may also be discussed for early or FIH clinical trials. Consideration should be given to the justification provided based on the non-clinical data, for the proposed starting dose, dose steps, and maximum exposure Anim totam molestiae Assessor’s discussion on the clinical development: Dignissimos ut qui d Consider what is new in this trial, the clinical relevance, and the medical need that the trial aims to address Illo cumque perferen Clinical Trial Rationale comments Qui quo eiusmod volu Consider if there are established primary endpoints for this type of study/indication, do they match the goals, are they validated? Consectetur et maxi Primary objectives comments Debitis sunt qui nis Secondary objectives workspace Atque nihil ea et re Secondary objectives comments Recusandae Magnam f Study population workspace Aut perferendis et q Study population comments A molestiae fugit i Take also into consideration the gender and age allocation of participants, and determine whether a specific group is excluded or underrepresented Incididunt Nam numqu Inclusion criteria comments Ea qui velit sint e Check if a justification is provided in the event that a specific group is excluded or underrepresented Applicable for registered products, consider the contraindications included in the SmPC for the investigational medical product, comparator, and auxiliary medical products Architecto molestias Exclusion criteria comments Voluptatem est id The inclusion of vulnerable population is justifiable only if this information cannot be obtained from non‑vulnerable populations For incapacitated or minor participants, the trial should offer some direct benefit to the tem or to the population that they represent Ducimus ducimus mo Vulnerable populations comments Ad velit autem aut l Brief description of the study plan and design, and whenever possible, include a diagram/flow chart Discuss the expected duration of the participants' participation and a description of the sequence and duration of all the clinical trial periods, including the follow up Harum ut alias repre Study plan and design comments Sed illo qui ea quo Consider the dose(s)/dose steps, dose rationale, route of administration, schedule, treatment duration, and dose modifications Aspernatur iste quia Study treatment comments Eum dolor consequatu Comparator IMP(s) workspace Quas sint voluptatem Comparator IMP(s) comments Do aliquip quidem qu Placebo workspace Expedita et laborios Placebo comments Voluptate cupiditate Auxilliary medicinal product(s) workspace Eu sit corporis et a Auxilliary medicinal product(s) comments In sunt asperiores d Additional considerations workspace Perferendis sint qui Additional considerations comments Ea doloremque duis e Brief description of the important safety risks associated with trial treatments identified in any previous clinical trials, and as outlined in the IB or SmPC, or from another source Nesciunt velit anim Safety comments Fugiat sunt occaeca Blinding and unblinding workspace Et ab quia id proide Blinding and unblinding comments Eum suscipit omnis r Contraception measures workspace Ea consequatur Nobi Contraception measures comments Tempor id id facere Discontinuation criteria workspace Natus incidunt qui Discontinuation criteria comments Facilis eos earum q Other concomitant workspace Quo libero est tene Other concomitant comments Delectus minima qua Safety and Monitoring workspace Sunt provident eum Safety and Monitoring comments Velit numquam dolore Reference Safety Information workspace Ratione dignissimos Reference Safety Information comments Quasi cum dolores po Data Safety Monitoring Committee workspace Aliquid adipisci mai Data Safety Monitoring Committee comments Velit nemo dolor odi Definition of the end of the trial workspace Odio minima neque ap Definition of the end of the trial comments Sed quia adipisci do Biological samples used in the study workspace Enim esse ex est e Biological samples used in the study comments Officiis et delectus Data protection workspace Autem repellendus E Data protection comments Consequat Rem sit s Recruitment and informed consent procedures workspace Tempor incidunt fac Recruitment and informed consent procedures comment Rerum tenetur expedi Benefit/risk assessment workspace Sint iusto facilis Comments on the benefit/risk: Inventore provident Assessor’s overall conclusions workspace Do ducimus necessit Overall comment/ conclusion on the clinical assessment: Doloremque rerum vol 1.5.1 REQUESTS FOR ADDITIONAL INFORMATION Neque minus vel veni Study plan and design workspace Ad in dolor id deser Study plan and design comments Mollit et aspernatur Randomization and blinding workspace Nemo quasi elit dol Randomization and blinding comments Expedita maiores vit Sample size, trial power and level of significance used workspace Optio nobis nostrum Sample size, trial power and level of significance used comments Exercitation deserun Planned analysis workspace Eum odio sint iure v Planned analysis comments Iusto esse ut repre Interim analysis workspace Enim dolor deleniti Interim analysis comments Iusto qui fugiat qui Assessor’s Overall Conclusion on the Statistical Part workspace Consectetur magni ve Assessor’s Overall Conclusion on the Statistical Part comments Laboris magna id es The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study: sample ECCT/24/12/01. This approval is valid for one year and in case the study extends beyond one year from the date of this letter, you are required to seek approval before proceeding with the study. The expiry date is 17th December 2025 <ol> <li> You should ensure compliance with Kenya Legal, regulatory and GCP requirements</li> <li> All safety reports should be submitted to ECCT as per the current PPB clinical trials guidelines</li> <li> It is your responsibility to inform the PPB of any changes to the protocol, research design and procedures that could introduce new or more than minimum risk to human subjects</li> <li> You are also reminded that upon conclusion of the study, you shall be required to submit the executive summary report of the study within 30 days while a copy of the clinical study report in ICH E3 format should be submitted to us within 180 days of the study closure</li> </ol> <div> Yours Sincerely, </div> :signature :approver For Chief Executive Officer 
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 content<h3 style="text-align: center;"> <img height="86" src="https://lh7-us.googleusercontent.com/eOWVvo3AHW74GguHveDaqdgy3YwNZqOqOO0QtscRoV4hJfcvt8Q6v4oLN3beVNvClvoD1ncu1RhB5D4iuAY-5R9h1aD2lEGqUorBVcQ0azfxsdvIz-WhbF3rA9-VQomtusnP2bNZTuYLFTC6vQ46nQ" style="background-color: transparent; color: rgb(0, 0, 0); font-family: "Bookman Old Style", serif; font-size: 11pt; white-space-collapse: preserve; margin-left: 0px; margin-top: 0px;" width="116" /></h3> MINISTRY OF HEALTH PHARMACY AND POISONS BOARD <table style="width: 100%; border:0px"> <tbody> <tr> <td style="width: 33.33%; border:0px"> <div id="left-editor"> Telegram: "MINHEALTH", Nairobi Cell phone: 0709 770 100 Email: info@pharmacyboardkenya.org Website: web.pharmacyboardkenya.org </div> </td> <td style="width: 33.33%;border:0px"> </td> <td style="width: 33.33%;border:0px"> <div id="right-editor"> Pharmacy and Poisons Board House Along Lenana Road P.O. Box 27663-00506 NAIROBI </div> </td> </tr> </tbody> </table> <address> </address> <address> When replying please quote</address> Ref. No. ECCT/10/2024-ECCT/24/12/01 7 Jan 2025 Lawrence Jennings Aladdin Powers Elton Delgado, Principal Investigator ECCT/24/12/01, Ut facere ea aliquam eveniet, Dear Sir/Madam, Re: ECCT/24/12/01 : Annual Approval; sample Et eius sit aut et fugiat adi. Reference is made to the above study. We acknowledge receipt of the following documents; <div style="margin-left: 15px;"> 1. Cover Letter (Should list all the submitted documents, their version numbers and dates) <a href="/attachments/download/1185">logo_is_b.jpg</a> dated 9th January 2025 Version 2. Annual progress report <a href="/attachments/download/1186">logo_is_b_2.jpg</a> dated 1st January 2025 Version 3. SAE and SUSAR cumulative logs <a href="/attachments/download/1187">logo_is_b_3.jpg</a> dated 8th January 2025 Version 5 4. Latest Data Safety Monitoring Board (DSMB) report <a href="/attachments/download/1188">logo_is_b_4.jpg</a> dated 6th January 2025 Version 6 5. Protocol Violations and Protocol Deviations logs <a href="/attachments/download/1189">logo_is_b_5.jpg</a> dated Version 6. Updated Investigators Brochure/Package inserts or Investigational Medicinal Product Dossier (IMPD) <a href="/attachments/download/1190">logo_is_b_6.jpg</a> dated 30th December 2024 Version 6 7. The Development Safety Update Report (DSUR) <a href="/attachments/download/1191">logo_is_b_7.jpg</a> dated Version 8. Copy of current favourable opinion letter from the local Ethics Review Committee (ERC). <a href="/attachments/download/1192">logo_is_b_8.jpg</a> dated Version 9. Copy of the Annual Practice License of the Investigators <a href="/attachments/download/1193">logo_is_b_9.jpg</a> dated Version 10. Copy of the Annual Practice License for the Pharmacist <a href="/attachments/download/1194">logo_is_b_10.jpg</a> dated Version 11. Copy of the valid professional indemnity insurance cover for the investigators <a href="/attachments/download/1195">logo_is_b_11.jpg</a> dated Version 12. Copy of the valid professional indemnity insurance cover for the study pharmacist <a href="/attachments/download/1196">logo_is_b_12.jpg</a> dated Version 13. Copy of valid participants’ clinical trials insurance cover <a href="/attachments/download/1197">logo_is_b_13.jpg</a> dated Version 14. Evidence of registration of the study at Pan African Clinical Trials Registry https://pactr.samrc.ac.za <a href="/attachments/download/1198">logo_is_b_14.jpg</a> dated Version 15. A signed checklist confirming the submission of the document <a href="/attachments/download/1199">logo_is_b_15.jpg</a> dated Version </div> After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials notes the following: 1.1 Introduction Maiores porro natus Primary pharmacodynamics comments Voluptatibus non cup Secondary pharmacodynamics comments Tenetur cillum ut nu Pharmacodynamic drug interactions comments Magni perferendis iu Pharmacokinetics comments Dolorum amet assume Absorption, Distribution, Metabolism & Excretion comments Qui eaque occaecat m Other pharmacokinetic studies comments Quaerat laboris dign Animal species selection/Study design comments Minim amet ea offic Single dose toxicity comments Voluptatem deleniti Repeat-dose toxicity comments Magnam omnis est des Genotoxicity comments Possimus sint tempo Carcinogenicity comments Repellendus Dolor i Reproductive and developmental toxicity - comments Officia dolore sit Juvenile toxicity studies comments Et aliqua Do eum qu Other studies (including enhanced PPND studies) comments Aut natus quibusdam Local tolerance comments Atque nostrum laboru Other toxicity studies comments Nostrud itaque volup Additional Considerations comments Quam eius rerum quia GLP aspects comments Voluptatibus in ex f Overall comment/ conclusion on the non-clinical assessment Eius sint ut debitis Trial category workspace Fugit obcaecati et Trial category comments Enim consequatur con Trial phase workspace Dolor dolore fuga S Trial phase comments (if in disagreement with the study phase proposed): Et debitis earum dol Therapeutic condition workspace A praesentium aut od Brief description of the disease Molestias ut aut non Brief discussion of clinical pharmacokinetic data, efficacy and safety data described in the IB from previous trials /previously investigated indications(s) for the IMP(s). Non-clinical studies may also be discussed for early or FIH clinical trials. Consideration should be given to the justification provided based on the non-clinical data, for the proposed starting dose, dose steps, and maximum exposure Anim totam molestiae Assessor’s discussion on the clinical development: Dignissimos ut qui d Consider what is new in this trial, the clinical relevance, and the medical need that the trial aims to address Illo cumque perferen Clinical Trial Rationale comments Qui quo eiusmod volu Consider if there are established primary endpoints for this type of study/indication, do they match the goals, are they validated? Consectetur et maxi Primary objectives comments Debitis sunt qui nis Secondary objectives workspace Atque nihil ea et re Secondary objectives comments Recusandae Magnam f Study population workspace Aut perferendis et q Study population comments A molestiae fugit i Take also into consideration the gender and age allocation of participants, and determine whether a specific group is excluded or underrepresented Incididunt Nam numqu Inclusion criteria comments Ea qui velit sint e Check if a justification is provided in the event that a specific group is excluded or underrepresented Applicable for registered products, consider the contraindications included in the SmPC for the investigational medical product, comparator, and auxiliary medical products Architecto molestias Exclusion criteria comments Voluptatem est id The inclusion of vulnerable population is justifiable only if this information cannot be obtained from non‑vulnerable populations For incapacitated or minor participants, the trial should offer some direct benefit to the tem or to the population that they represent Ducimus ducimus mo Vulnerable populations comments Ad velit autem aut l Brief description of the study plan and design, and whenever possible, include a diagram/flow chart Discuss the expected duration of the participants' participation and a description of the sequence and duration of all the clinical trial periods, including the follow up Harum ut alias repre Study plan and design comments Sed illo qui ea quo Consider the dose(s)/dose steps, dose rationale, route of administration, schedule, treatment duration, and dose modifications Aspernatur iste quia Study treatment comments Eum dolor consequatu Comparator IMP(s) workspace Quas sint voluptatem Comparator IMP(s) comments Do aliquip quidem qu Placebo workspace Expedita et laborios Placebo comments Voluptate cupiditate Auxilliary medicinal product(s) workspace Eu sit corporis et a Auxilliary medicinal product(s) comments In sunt asperiores d Additional considerations workspace Perferendis sint qui Additional considerations comments Ea doloremque duis e Brief description of the important safety risks associated with trial treatments identified in any previous clinical trials, and as outlined in the IB or SmPC, or from another source Nesciunt velit anim Safety comments Fugiat sunt occaeca Blinding and unblinding workspace Et ab quia id proide Blinding and unblinding comments Eum suscipit omnis r Contraception measures workspace Ea consequatur Nobi Contraception measures comments Tempor id id facere Discontinuation criteria workspace Natus incidunt qui Discontinuation criteria comments Facilis eos earum q Other concomitant workspace Quo libero est tene Other concomitant comments Delectus minima qua Safety and Monitoring workspace Sunt provident eum Safety and Monitoring comments Velit numquam dolore Reference Safety Information workspace Ratione dignissimos Reference Safety Information comments Quasi cum dolores po Data Safety Monitoring Committee workspace Aliquid adipisci mai Data Safety Monitoring Committee comments Velit nemo dolor odi Definition of the end of the trial workspace Odio minima neque ap Definition of the end of the trial comments Sed quia adipisci do Biological samples used in the study workspace Enim esse ex est e Biological samples used in the study comments Officiis et delectus Data protection workspace Autem repellendus E Data protection comments Consequat Rem sit s Recruitment and informed consent procedures workspace Tempor incidunt fac Recruitment and informed consent procedures comment Rerum tenetur expedi Benefit/risk assessment workspace Sint iusto facilis Comments on the benefit/risk: Inventore provident Assessor’s overall conclusions workspace Do ducimus necessit Overall comment/ conclusion on the clinical assessment: Doloremque rerum vol 1.5.1 REQUESTS FOR ADDITIONAL INFORMATION Neque minus vel veni Study plan and design workspace Ad in dolor id deser Study plan and design comments Mollit et aspernatur Randomization and blinding workspace Nemo quasi elit dol Randomization and blinding comments Expedita maiores vit Sample size, trial power and level of significance used workspace Optio nobis nostrum Sample size, trial power and level of significance used comments Exercitation deserun Planned analysis workspace Eum odio sint iure v Planned analysis comments Iusto esse ut repre Interim analysis workspace Enim dolor deleniti Interim analysis comments Iusto qui fugiat qui Assessor’s Overall Conclusion on the Statistical Part workspace Consectetur magni ve Assessor’s Overall Conclusion on the Statistical Part comments Laboris magna id es The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study: sample ECCT/24/12/01. This approval is valid for one year and in case the study extends beyond one year from the date of this letter, you are required to seek approval before proceeding with the study. The expiry date is 7th January 2026 <ol> <li> You should ensure compliance with Kenya Legal, regulatory and GCP requirements</li> <li> All safety reports should be submitted to ECCT as per the current PPB clinical trials guidelines</li> <li> It is your responsibility to inform the PPB of any changes to the protocol, research design and procedures that could introduce new or more than minimum risk to human subjects</li> <li> You are also reminded that upon conclusion of the study, you shall be required to submit the executive summary report of the study within 30 days while a copy of the clinical study report in ICH E3 format should be submitted to us within 180 days of the study closure</li> </ol> <div> Yours Sincerely, </div> :signature :approver For Chief Executive Officer 
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 content<h3 style="text-align: center;"> <img height="86" src="https://lh7-us.googleusercontent.com/eOWVvo3AHW74GguHveDaqdgy3YwNZqOqOO0QtscRoV4hJfcvt8Q6v4oLN3beVNvClvoD1ncu1RhB5D4iuAY-5R9h1aD2lEGqUorBVcQ0azfxsdvIz-WhbF3rA9-VQomtusnP2bNZTuYLFTC6vQ46nQ" style="background-color: transparent; color: rgb(0, 0, 0); font-family: "Bookman Old Style", serif; font-size: 11pt; white-space-collapse: preserve; margin-left: 0px; margin-top: 0px;" width="116" /></h3> MINISTRY OF HEALTH PHARMACY AND POISONS BOARD <table style="width: 100%; border:0px"> <tbody> <tr> <td style="width: 33.33%; border:0px"> <div id="left-editor"> Telegram: "MINHEALTH", Nairobi Cell phone: 0709 770 100 Email: info@pharmacyboardkenya.org Website: web.pharmacyboardkenya.org </div> </td> <td style="width: 33.33%;border:0px"> </td> <td style="width: 33.33%;border:0px"> <div id="right-editor"> Pharmacy and Poisons Board House Along Lenana Road P.O. Box 27663-00506 NAIROBI </div> </td> </tr> </tbody> </table> <address> </address> <address> When replying please quote</address> Ref. No. ECCT/11/2024-ECCT/24/12/01 7 Jan 2025 Lawrence Jennings Aladdin Powers Elton Delgado, Principal Investigator ECCT/24/12/01, Ut facere ea aliquam eveniet, Dear Sir/Madam, Re: ECCT/24/12/01 : Initial Approval; sample Et eius sit aut et fugiat adi. Reference is made to the above study. We acknowledge receipt of the following documents; <div style="margin-left: 15px;"> 1. GMP certificate of the investigational product from the site of manufacture <a href="/attachments/download/1071">screenshot_from_2024_11_28_11_17_15.png</a> dated 28th November 2024 Version 5 2. Cover Letter (Should list all the submitted documents, their version numbers and dates) <a href="/attachments/download/1118">logo_46.png</a> dated 1st December 2024 Version 1 3. The Study Protocol <a href="/attachments/download/1119">logo_47.png</a> dated 2nd December 2024 Version 3 4. Registration of the study at Pan African Clinical Trials Registry https://pactr.samrc.ac.za <a href="/attachments/download/1120">logo_48.png</a> dated 10th December 2024 Version 4 5. Patient Information leaflet and Informed consent form <a href="/attachments/download/1121">logo_49.png</a> dated 1st December 2024 Version 4 6. Investigators Brochure/Package inserts <a href="/attachments/download/1122">logo_50.png</a> dated 3rd December 2024 Version 3 7. Investigational Medicinal Product Dossier (IMPD) <a href="/attachments/download/1123">logo_51.png</a> dated 2nd December 2024 Version 3 8. Adequate data and information from previous studies and Phases to support carrying out of the current study <a href="/attachments/download/1124">logo_52.png</a> dated 2nd December 2024 Version 3 9. Stability data of the investigational product <a href="/attachments/download/1125">logo_53.png</a> dated 3rd December 2024 Version 3 10. Certificate of Analysis of the investigational product <a href="/attachments/download/1126">logo_54.png</a> dated 2nd December 2024 Version 4 11. Pictorial Sample of the investigational products. This sample should include the text of the labeling to be used <a href="/attachments/download/1127">logo_55.png</a> dated 3rd December 2024 Version 4 12. Signed investigator(s) CV(s) including that of study Pharmacist (NB: The CV should include the current workload of the Principal Investigator ) <a href="/attachments/download/1128">logo_56.png</a> dated 3rd December 2024 Version 4 13. Evidence of contractual agreement between sponsor and Principal Investigator. <a href="/attachments/download/1129">logo_57.png</a> dated 2nd December 2024 Version 4 14. DSMB Charter including the composition and meeting schedule <a href="/attachments/download/1130">logo_58.png</a> dated 2nd December 2024 Version 2 15. Evidence of recent GCP training of the core study staff <a href="/attachments/download/1131">logo_59.png</a> dated 4th December 2024 Version 6 16. Detailed budget of the study <a href="/attachments/download/1132">logo_60.png</a> dated 3rd December 2024 Version 4 17. Financial declaration by Sponsor and/or PI <a href="/attachments/download/1133">logo_61.png</a> dated 10th December 2024 Version 5 18. Signed Declaration by Sponsor or Principal investigator that the study will be carried out according to the protocol and applicable laws, regulations and GCP requirements. <a href="/attachments/download/1134">logo_62.png</a> dated 3rd December 2024 Version 3 19. Indemnity cover for PI, investigators and study Pharmacist. <a href="/attachments/download/1135">logo_63.png</a> dated 3rd December 2024 Version 5 20. Clinical Trials Insurance cover for study participants <a href="/attachments/download/1136">logo_64.png</a> dated 3rd December 2024 Version 2 21. Copy of current Practice Licenses for the Investigators and study Pharmacist <a href="/attachments/download/1137">logo_65.png</a> dated 2nd December 2024 Version 2 22. Copy of favorable opinion letter from the local Ethics Review Committee (ERC). <a href="/attachments/download/1138">logo_66.png</a> dated 3rd December 2024 Version 1 23. Copy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable <a href="/attachments/download/1139">logo_67.png</a> dated 2nd December 2024 Version 1 24. For multicentre/multi-site studies, a site specific addendum for each of the proposed sites including among other things the sites’ capacity to carry out the study i.e personnel, equipment, laboratory etc <a href="/attachments/download/1140">logo_68.png</a> dated 12th December 2024 Version 5 25. Statistical Analysis Plan <a href="/attachments/download/1141">logo_69.png</a> dated 2nd December 2024 Version 1 26. Signed Checklist <a href="/attachments/download/1142">logo_70.png</a> dated 2nd December 2024 Version 2 27. Payment of fees <a href="/attachments/download/1143">logo_71.png</a> dated 2nd December 2024 Version 9 28. A signed statement by the applicant indicating that all information contained in, or referenced by, the application is complete and accurate and is not false or misleading. <a href="/attachments/download/1144">logo_72.png</a> dated 13th December 2024 Version 2 </div> After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials notes the following: 1.1 Introduction Maiores porro natus Primary pharmacodynamics comments Voluptatibus non cup Secondary pharmacodynamics comments Tenetur cillum ut nu Pharmacodynamic drug interactions comments Magni perferendis iu Pharmacokinetics comments Dolorum amet assume Absorption, Distribution, Metabolism & Excretion comments Qui eaque occaecat m Other pharmacokinetic studies comments Quaerat laboris dign Animal species selection/Study design comments Minim amet ea offic Single dose toxicity comments Voluptatem deleniti Repeat-dose toxicity comments Magnam omnis est des Genotoxicity comments Possimus sint tempo Carcinogenicity comments Repellendus Dolor i Reproductive and developmental toxicity - comments Officia dolore sit Juvenile toxicity studies comments Et aliqua Do eum qu Other studies (including enhanced PPND studies) comments Aut natus quibusdam Local tolerance comments Atque nostrum laboru Other toxicity studies comments Nostrud itaque volup Additional Considerations comments Quam eius rerum quia GLP aspects comments Voluptatibus in ex f Overall comment/ conclusion on the non-clinical assessment Eius sint ut debitis Trial category workspace Fugit obcaecati et Trial category comments Enim consequatur con Trial phase workspace Dolor dolore fuga S Trial phase comments (if in disagreement with the study phase proposed): Et debitis earum dol Therapeutic condition workspace A praesentium aut od Brief description of the disease Molestias ut aut non Brief discussion of clinical pharmacokinetic data, efficacy and safety data described in the IB from previous trials /previously investigated indications(s) for the IMP(s). Non-clinical studies may also be discussed for early or FIH clinical trials. Consideration should be given to the justification provided based on the non-clinical data, for the proposed starting dose, dose steps, and maximum exposure Anim totam molestiae Assessor’s discussion on the clinical development: Dignissimos ut qui d Consider what is new in this trial, the clinical relevance, and the medical need that the trial aims to address Illo cumque perferen Clinical Trial Rationale comments Qui quo eiusmod volu Consider if there are established primary endpoints for this type of study/indication, do they match the goals, are they validated? Consectetur et maxi Primary objectives comments Debitis sunt qui nis Secondary objectives workspace Atque nihil ea et re Secondary objectives comments Recusandae Magnam f Study population workspace Aut perferendis et q Study population comments A molestiae fugit i Take also into consideration the gender and age allocation of participants, and determine whether a specific group is excluded or underrepresented Incididunt Nam numqu Inclusion criteria comments Ea qui velit sint e Check if a justification is provided in the event that a specific group is excluded or underrepresented Applicable for registered products, consider the contraindications included in the SmPC for the investigational medical product, comparator, and auxiliary medical products Architecto molestias Exclusion criteria comments Voluptatem est id The inclusion of vulnerable population is justifiable only if this information cannot be obtained from non‑vulnerable populations For incapacitated or minor participants, the trial should offer some direct benefit to the tem or to the population that they represent Ducimus ducimus mo Vulnerable populations comments Ad velit autem aut l Brief description of the study plan and design, and whenever possible, include a diagram/flow chart Discuss the expected duration of the participants' participation and a description of the sequence and duration of all the clinical trial periods, including the follow up Harum ut alias repre Study plan and design comments Sed illo qui ea quo Consider the dose(s)/dose steps, dose rationale, route of administration, schedule, treatment duration, and dose modifications Aspernatur iste quia Study treatment comments Eum dolor consequatu Comparator IMP(s) workspace Quas sint voluptatem Comparator IMP(s) comments Do aliquip quidem qu Placebo workspace Expedita et laborios Placebo comments Voluptate cupiditate Auxilliary medicinal product(s) workspace Eu sit corporis et a Auxilliary medicinal product(s) comments In sunt asperiores d Additional considerations workspace Perferendis sint qui Additional considerations comments Ea doloremque duis e Brief description of the important safety risks associated with trial treatments identified in any previous clinical trials, and as outlined in the IB or SmPC, or from another source Nesciunt velit anim Safety comments Fugiat sunt occaeca Blinding and unblinding workspace Et ab quia id proide Blinding and unblinding comments Eum suscipit omnis r Contraception measures workspace Ea consequatur Nobi Contraception measures comments Tempor id id facere Discontinuation criteria workspace Natus incidunt qui Discontinuation criteria comments Facilis eos earum q Other concomitant workspace Quo libero est tene Other concomitant comments Delectus minima qua Safety and Monitoring workspace Sunt provident eum Safety and Monitoring comments Velit numquam dolore Reference Safety Information workspace Ratione dignissimos Reference Safety Information comments Quasi cum dolores po Data Safety Monitoring Committee workspace Aliquid adipisci mai Data Safety Monitoring Committee comments Velit nemo dolor odi Definition of the end of the trial workspace Odio minima neque ap Definition of the end of the trial comments Sed quia adipisci do Biological samples used in the study workspace Enim esse ex est e Biological samples used in the study comments Officiis et delectus Data protection workspace Autem repellendus E Data protection comments Consequat Rem sit s Recruitment and informed consent procedures workspace Tempor incidunt fac Recruitment and informed consent procedures comment Rerum tenetur expedi Benefit/risk assessment workspace Sint iusto facilis Comments on the benefit/risk: Inventore provident Assessor’s overall conclusions workspace Do ducimus necessit Overall comment/ conclusion on the clinical assessment: Doloremque rerum vol 1.5.1 REQUESTS FOR ADDITIONAL INFORMATION Neque minus vel veni Study plan and design workspace Ad in dolor id deser Study plan and design comments Mollit et aspernatur Randomization and blinding workspace Nemo quasi elit dol Randomization and blinding comments Expedita maiores vit Sample size, trial power and level of significance used workspace Optio nobis nostrum Sample size, trial power and level of significance used comments Exercitation deserun Planned analysis workspace Eum odio sint iure v Planned analysis comments Iusto esse ut repre Interim analysis workspace Enim dolor deleniti Interim analysis comments Iusto qui fugiat qui Assessor’s Overall Conclusion on the Statistical Part workspace Consectetur magni ve Assessor’s Overall Conclusion on the Statistical Part comments Laboris magna id es The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study: sample ECCT/24/12/01. This approval is valid for one year and in case the study extends beyond one year from the date of this letter, you are required to seek approval before proceeding with the study. The expiry date is 17th December 2025 <ol> <li> You should ensure compliance with Kenya Legal, regulatory and GCP requirements</li> <li> All safety reports should be submitted to ECCT as per the current PPB clinical trials guidelines</li> <li> It is your responsibility to inform the PPB of any changes to the protocol, research design and procedures that could introduce new or more than minimum risk to human subjects</li> <li> You are also reminded that upon conclusion of the study, you shall be required to submit the executive summary report of the study within 30 days while a copy of the clinical study report in ICH E3 format should be submitted to us within 180 days of the study closure</li> </ol> <div> Yours Sincerely, </div> :signature :approver For Chief Executive Officer 
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 content<h3 style="text-align: center;"> <img height="86" src="https://lh7-us.googleusercontent.com/eOWVvo3AHW74GguHveDaqdgy3YwNZqOqOO0QtscRoV4hJfcvt8Q6v4oLN3beVNvClvoD1ncu1RhB5D4iuAY-5R9h1aD2lEGqUorBVcQ0azfxsdvIz-WhbF3rA9-VQomtusnP2bNZTuYLFTC6vQ46nQ" style="background-color: transparent; color: rgb(0, 0, 0); font-family: "Bookman Old Style", serif; font-size: 11pt; white-space-collapse: preserve; margin-left: 0px; margin-top: 0px;" width="116" /></h3> MINISTRY OF HEALTH PHARMACY AND POISONS BOARD <table style="width: 100%; border:0px"> <tbody> <tr> <td style="width: 33.33%; border:0px"> <div id="left-editor"> Telegram: "MINHEALTH", Nairobi Cell phone: 0709 770 100 Email: info@pharmacyboardkenya.org Website: web.pharmacyboardkenya.org </div> </td> <td style="width: 33.33%;border:0px"> </td> <td style="width: 33.33%;border:0px"> <div id="right-editor"> Pharmacy and Poisons Board House Along Lenana Road P.O. Box 27663-00506 NAIROBI </div> </td> </tr> </tbody> </table> <address> </address> <address> When replying please quote</address> Ref. No. ECCT/12/2024-ECCT/24/12/01 7 Jan 2025 Lawrence Jennings Aladdin Powers Elton Delgado, Principal Investigator ECCT/24/12/01, Ut facere ea aliquam eveniet, Dear Sir/Madam, Re: ECCT/24/12/01 : Initial Approval; sample Et eius sit aut et fugiat adi. Reference is made to the above study. We acknowledge receipt of the following documents; <div style="margin-left: 15px;"> 1. GMP certificate of the investigational product from the site of manufacture <a href="/attachments/download/1071">screenshot_from_2024_11_28_11_17_15.png</a> dated 28th November 2024 Version 5 2. Cover Letter (Should list all the submitted documents, their version numbers and dates) <a href="/attachments/download/1118">logo_46.png</a> dated 1st December 2024 Version 1 3. The Study Protocol <a href="/attachments/download/1119">logo_47.png</a> dated 2nd December 2024 Version 3 4. Registration of the study at Pan African Clinical Trials Registry https://pactr.samrc.ac.za <a href="/attachments/download/1120">logo_48.png</a> dated 10th December 2024 Version 4 5. Patient Information leaflet and Informed consent form <a href="/attachments/download/1121">logo_49.png</a> dated 1st December 2024 Version 4 6. Investigators Brochure/Package inserts <a href="/attachments/download/1122">logo_50.png</a> dated 3rd December 2024 Version 3 7. Investigational Medicinal Product Dossier (IMPD) <a href="/attachments/download/1123">logo_51.png</a> dated 2nd December 2024 Version 3 8. Adequate data and information from previous studies and Phases to support carrying out of the current study <a href="/attachments/download/1124">logo_52.png</a> dated 2nd December 2024 Version 3 9. Stability data of the investigational product <a href="/attachments/download/1125">logo_53.png</a> dated 3rd December 2024 Version 3 10. Certificate of Analysis of the investigational product <a href="/attachments/download/1126">logo_54.png</a> dated 2nd December 2024 Version 4 11. Pictorial Sample of the investigational products. This sample should include the text of the labeling to be used <a href="/attachments/download/1127">logo_55.png</a> dated 3rd December 2024 Version 4 12. Signed investigator(s) CV(s) including that of study Pharmacist (NB: The CV should include the current workload of the Principal Investigator ) <a href="/attachments/download/1128">logo_56.png</a> dated 3rd December 2024 Version 4 13. Evidence of contractual agreement between sponsor and Principal Investigator. <a href="/attachments/download/1129">logo_57.png</a> dated 2nd December 2024 Version 4 14. DSMB Charter including the composition and meeting schedule <a href="/attachments/download/1130">logo_58.png</a> dated 2nd December 2024 Version 2 15. Evidence of recent GCP training of the core study staff <a href="/attachments/download/1131">logo_59.png</a> dated 4th December 2024 Version 6 16. Detailed budget of the study <a href="/attachments/download/1132">logo_60.png</a> dated 3rd December 2024 Version 4 17. Financial declaration by Sponsor and/or PI <a href="/attachments/download/1133">logo_61.png</a> dated 10th December 2024 Version 5 18. Signed Declaration by Sponsor or Principal investigator that the study will be carried out according to the protocol and applicable laws, regulations and GCP requirements. <a href="/attachments/download/1134">logo_62.png</a> dated 3rd December 2024 Version 3 19. Indemnity cover for PI, investigators and study Pharmacist. <a href="/attachments/download/1135">logo_63.png</a> dated 3rd December 2024 Version 5 20. Clinical Trials Insurance cover for study participants <a href="/attachments/download/1136">logo_64.png</a> dated 3rd December 2024 Version 2 21. Copy of current Practice Licenses for the Investigators and study Pharmacist <a href="/attachments/download/1137">logo_65.png</a> dated 2nd December 2024 Version 2 22. Copy of favorable opinion letter from the local Ethics Review Committee (ERC). <a href="/attachments/download/1138">logo_66.png</a> dated 3rd December 2024 Version 1 23. Copy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable <a href="/attachments/download/1139">logo_67.png</a> dated 2nd December 2024 Version 1 24. For multicentre/multi-site studies, a site specific addendum for each of the proposed sites including among other things the sites’ capacity to carry out the study i.e personnel, equipment, laboratory etc <a href="/attachments/download/1140">logo_68.png</a> dated 12th December 2024 Version 5 25. Statistical Analysis Plan <a href="/attachments/download/1141">logo_69.png</a> dated 2nd December 2024 Version 1 26. Signed Checklist <a href="/attachments/download/1142">logo_70.png</a> dated 2nd December 2024 Version 2 27. Payment of fees <a href="/attachments/download/1143">logo_71.png</a> dated 2nd December 2024 Version 9 28. A signed statement by the applicant indicating that all information contained in, or referenced by, the application is complete and accurate and is not false or misleading. <a href="/attachments/download/1144">logo_72.png</a> dated 13th December 2024 Version 2 </div> After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials notes the following: 1.1 Introduction Maiores porro natus Primary pharmacodynamics comments Voluptatibus non cup Secondary pharmacodynamics comments Tenetur cillum ut nu Pharmacodynamic drug interactions comments Magni perferendis iu Pharmacokinetics comments Dolorum amet assume Absorption, Distribution, Metabolism & Excretion comments Qui eaque occaecat m Other pharmacokinetic studies comments Quaerat laboris dign Animal species selection/Study design comments Minim amet ea offic Single dose toxicity comments Voluptatem deleniti Repeat-dose toxicity comments Magnam omnis est des Genotoxicity comments Possimus sint tempo Carcinogenicity comments Repellendus Dolor i Reproductive and developmental toxicity - comments Officia dolore sit Juvenile toxicity studies comments Et aliqua Do eum qu Other studies (including enhanced PPND studies) comments Aut natus quibusdam Local tolerance comments Atque nostrum laboru Other toxicity studies comments Nostrud itaque volup Additional Considerations comments Quam eius rerum quia GLP aspects comments Voluptatibus in ex f Overall comment/ conclusion on the non-clinical assessment Eius sint ut debitis Trial category workspace Fugit obcaecati et Trial category comments Enim consequatur con Trial phase workspace Dolor dolore fuga S Trial phase comments (if in disagreement with the study phase proposed): Et debitis earum dol Therapeutic condition workspace A praesentium aut od Brief description of the disease Molestias ut aut non Brief discussion of clinical pharmacokinetic data, efficacy and safety data described in the IB from previous trials /previously investigated indications(s) for the IMP(s). Non-clinical studies may also be discussed for early or FIH clinical trials. Consideration should be given to the justification provided based on the non-clinical data, for the proposed starting dose, dose steps, and maximum exposure Anim totam molestiae Assessor’s discussion on the clinical development: Dignissimos ut qui d Consider what is new in this trial, the clinical relevance, and the medical need that the trial aims to address Illo cumque perferen Clinical Trial Rationale comments Qui quo eiusmod volu Consider if there are established primary endpoints for this type of study/indication, do they match the goals, are they validated? Consectetur et maxi Primary objectives comments Debitis sunt qui nis Secondary objectives workspace Atque nihil ea et re Secondary objectives comments Recusandae Magnam f Study population workspace Aut perferendis et q Study population comments A molestiae fugit i Take also into consideration the gender and age allocation of participants, and determine whether a specific group is excluded or underrepresented Incididunt Nam numqu Inclusion criteria comments Ea qui velit sint e Check if a justification is provided in the event that a specific group is excluded or underrepresented Applicable for registered products, consider the contraindications included in the SmPC for the investigational medical product, comparator, and auxiliary medical products Architecto molestias Exclusion criteria comments Voluptatem est id The inclusion of vulnerable population is justifiable only if this information cannot be obtained from non‑vulnerable populations For incapacitated or minor participants, the trial should offer some direct benefit to the tem or to the population that they represent Ducimus ducimus mo Vulnerable populations comments Ad velit autem aut l Brief description of the study plan and design, and whenever possible, include a diagram/flow chart Discuss the expected duration of the participants' participation and a description of the sequence and duration of all the clinical trial periods, including the follow up Harum ut alias repre Study plan and design comments Sed illo qui ea quo Consider the dose(s)/dose steps, dose rationale, route of administration, schedule, treatment duration, and dose modifications Aspernatur iste quia Study treatment comments Eum dolor consequatu Comparator IMP(s) workspace Quas sint voluptatem Comparator IMP(s) comments Do aliquip quidem qu Placebo workspace Expedita et laborios Placebo comments Voluptate cupiditate Auxilliary medicinal product(s) workspace Eu sit corporis et a Auxilliary medicinal product(s) comments In sunt asperiores d Additional considerations workspace Perferendis sint qui Additional considerations comments Ea doloremque duis e Brief description of the important safety risks associated with trial treatments identified in any previous clinical trials, and as outlined in the IB or SmPC, or from another source Nesciunt velit anim Safety comments Fugiat sunt occaeca Blinding and unblinding workspace Et ab quia id proide Blinding and unblinding comments Eum suscipit omnis r Contraception measures workspace Ea consequatur Nobi Contraception measures comments Tempor id id facere Discontinuation criteria workspace Natus incidunt qui Discontinuation criteria comments Facilis eos earum q Other concomitant workspace Quo libero est tene Other concomitant comments Delectus minima qua Safety and Monitoring workspace Sunt provident eum Safety and Monitoring comments Velit numquam dolore Reference Safety Information workspace Ratione dignissimos Reference Safety Information comments Quasi cum dolores po Data Safety Monitoring Committee workspace Aliquid adipisci mai Data Safety Monitoring Committee comments Velit nemo dolor odi Definition of the end of the trial workspace Odio minima neque ap Definition of the end of the trial comments Sed quia adipisci do Biological samples used in the study workspace Enim esse ex est e Biological samples used in the study comments Officiis et delectus Data protection workspace Autem repellendus E Data protection comments Consequat Rem sit s Recruitment and informed consent procedures workspace Tempor incidunt fac Recruitment and informed consent procedures comment Rerum tenetur expedi Benefit/risk assessment workspace Sint iusto facilis Comments on the benefit/risk: Inventore provident Assessor’s overall conclusions workspace Do ducimus necessit Overall comment/ conclusion on the clinical assessment: Doloremque rerum vol 1.5.1 REQUESTS FOR ADDITIONAL INFORMATION Neque minus vel veni Study plan and design workspace Ad in dolor id deser Study plan and design comments Mollit et aspernatur Randomization and blinding workspace Nemo quasi elit dol Randomization and blinding comments Expedita maiores vit Sample size, trial power and level of significance used workspace Optio nobis nostrum Sample size, trial power and level of significance used comments Exercitation deserun Planned analysis workspace Eum odio sint iure v Planned analysis comments Iusto esse ut repre Interim analysis workspace Enim dolor deleniti Interim analysis comments Iusto qui fugiat qui Assessor’s Overall Conclusion on the Statistical Part workspace Consectetur magni ve Assessor’s Overall Conclusion on the Statistical Part comments Laboris magna id es The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study: sample ECCT/24/12/01. This approval is valid for one year and in case the study extends beyond one year from the date of this letter, you are required to seek approval before proceeding with the study. The expiry date is 17th December 2025 <ol> <li> You should ensure compliance with Kenya Legal, regulatory and GCP requirements</li> <li> All safety reports should be submitted to ECCT as per the current PPB clinical trials guidelines</li> <li> It is your responsibility to inform the PPB of any changes to the protocol, research design and procedures that could introduce new or more than minimum risk to human subjects</li> <li> You are also reminded that upon conclusion of the study, you shall be required to submit the executive summary report of the study within 30 days while a copy of the clinical study report in ICH E3 format should be submitted to us within 180 days of the study closure</li> </ol> <div> Yours Sincerely, </div> :signature :approver For Chief Executive Officer 
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 approvermanager
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 statussubmitted
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 deleted_date(null)
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 content<h3 style="text-align: center;"> <img height="86" src="https://lh7-us.googleusercontent.com/eOWVvo3AHW74GguHveDaqdgy3YwNZqOqOO0QtscRoV4hJfcvt8Q6v4oLN3beVNvClvoD1ncu1RhB5D4iuAY-5R9h1aD2lEGqUorBVcQ0azfxsdvIz-WhbF3rA9-VQomtusnP2bNZTuYLFTC6vQ46nQ" style="background-color: transparent; color: rgb(0, 0, 0); font-family: "Bookman Old Style", serif; font-size: 11pt; white-space-collapse: preserve; margin-left: 0px; margin-top: 0px;" width="116" /></h3> MINISTRY OF HEALTH PHARMACY AND POISONS BOARD <table style="width: 100%; border:0px"> <tbody> <tr> <td style="width: 33.33%; border:0px"> <div id="left-editor"> Telegram: "MINHEALTH", Nairobi Cell phone: 0709 770 100 Email: info@pharmacyboardkenya.org Website: web.pharmacyboardkenya.org </div> </td> <td style="width: 33.33%;border:0px"> </td> <td style="width: 33.33%;border:0px"> <div id="right-editor"> Pharmacy and Poisons Board House Along Lenana Road P.O. Box 27663-00506 NAIROBI </div> </td> </tr> </tbody> </table> <address> </address> <address> When replying please quote</address> Ref. No. ECCT/13/2024-ECCT/24/12/01 7 Jan 2025 Lawrence Jennings Aladdin Powers Elton Delgado, Principal Investigator ECCT/24/12/01, Ut facere ea aliquam eveniet, Dear Sir/Madam, Re: ECCT/24/12/01 : Annual Approval; sample Et eius sit aut et fugiat adi. Reference is made to the above study. We acknowledge receipt of the following documents; <div style="margin-left: 15px;"> 1. Cover Letter (Should list all the submitted documents, their version numbers and dates) <a href="/attachments/download/1185">logo_is_b.jpg</a> dated 9th January 2025 Version 2. Annual progress report <a href="/attachments/download/1186">logo_is_b_2.jpg</a> dated 1st January 2025 Version 3. SAE and SUSAR cumulative logs <a href="/attachments/download/1187">logo_is_b_3.jpg</a> dated 8th January 2025 Version 5 4. Latest Data Safety Monitoring Board (DSMB) report <a href="/attachments/download/1188">logo_is_b_4.jpg</a> dated 6th January 2025 Version 6 5. Protocol Violations and Protocol Deviations logs <a href="/attachments/download/1189">logo_is_b_5.jpg</a> dated Version 6. Updated Investigators Brochure/Package inserts or Investigational Medicinal Product Dossier (IMPD) <a href="/attachments/download/1190">logo_is_b_6.jpg</a> dated 30th December 2024 Version 6 7. The Development Safety Update Report (DSUR) <a href="/attachments/download/1191">logo_is_b_7.jpg</a> dated Version 8. Copy of current favourable opinion letter from the local Ethics Review Committee (ERC). <a href="/attachments/download/1192">logo_is_b_8.jpg</a> dated Version 9. Copy of the Annual Practice License of the Investigators <a href="/attachments/download/1193">logo_is_b_9.jpg</a> dated Version 10. Copy of the Annual Practice License for the Pharmacist <a href="/attachments/download/1194">logo_is_b_10.jpg</a> dated Version 11. Copy of the valid professional indemnity insurance cover for the investigators <a href="/attachments/download/1195">logo_is_b_11.jpg</a> dated Version 12. Copy of the valid professional indemnity insurance cover for the study pharmacist <a href="/attachments/download/1196">logo_is_b_12.jpg</a> dated Version 13. Copy of valid participants’ clinical trials insurance cover <a href="/attachments/download/1197">logo_is_b_13.jpg</a> dated Version 14. Evidence of registration of the study at Pan African Clinical Trials Registry https://pactr.samrc.ac.za <a href="/attachments/download/1198">logo_is_b_14.jpg</a> dated Version 15. A signed checklist confirming the submission of the document <a href="/attachments/download/1199">logo_is_b_15.jpg</a> dated Version </div> After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials notes the following: 1.1 Introduction Maiores porro natus Primary pharmacodynamics comments Voluptatibus non cup Secondary pharmacodynamics comments Tenetur cillum ut nu Pharmacodynamic drug interactions comments Magni perferendis iu Pharmacokinetics comments Dolorum amet assume Absorption, Distribution, Metabolism & Excretion comments Qui eaque occaecat m Other pharmacokinetic studies comments Quaerat laboris dign Animal species selection/Study design comments Minim amet ea offic Single dose toxicity comments Voluptatem deleniti Repeat-dose toxicity comments Magnam omnis est des Genotoxicity comments Possimus sint tempo Carcinogenicity comments Repellendus Dolor i Reproductive and developmental toxicity - comments Officia dolore sit Juvenile toxicity studies comments Et aliqua Do eum qu Other studies (including enhanced PPND studies) comments Aut natus quibusdam Local tolerance comments Atque nostrum laboru Other toxicity studies comments Nostrud itaque volup Additional Considerations comments Quam eius rerum quia GLP aspects comments Voluptatibus in ex f Overall comment/ conclusion on the non-clinical assessment Eius sint ut debitis Trial category workspace Fugit obcaecati et Trial category comments Enim consequatur con Trial phase workspace Dolor dolore fuga S Trial phase comments (if in disagreement with the study phase proposed): Et debitis earum dol Therapeutic condition workspace A praesentium aut od Brief description of the disease Molestias ut aut non Brief discussion of clinical pharmacokinetic data, efficacy and safety data described in the IB from previous trials /previously investigated indications(s) for the IMP(s). Non-clinical studies may also be discussed for early or FIH clinical trials. Consideration should be given to the justification provided based on the non-clinical data, for the proposed starting dose, dose steps, and maximum exposure Anim totam molestiae Assessor’s discussion on the clinical development: Dignissimos ut qui d Consider what is new in this trial, the clinical relevance, and the medical need that the trial aims to address Illo cumque perferen Clinical Trial Rationale comments Qui quo eiusmod volu Consider if there are established primary endpoints for this type of study/indication, do they match the goals, are they validated? Consectetur et maxi Primary objectives comments Debitis sunt qui nis Secondary objectives workspace Atque nihil ea et re Secondary objectives comments Recusandae Magnam f Study population workspace Aut perferendis et q Study population comments A molestiae fugit i Take also into consideration the gender and age allocation of participants, and determine whether a specific group is excluded or underrepresented Incididunt Nam numqu Inclusion criteria comments Ea qui velit sint e Check if a justification is provided in the event that a specific group is excluded or underrepresented Applicable for registered products, consider the contraindications included in the SmPC for the investigational medical product, comparator, and auxiliary medical products Architecto molestias Exclusion criteria comments Voluptatem est id The inclusion of vulnerable population is justifiable only if this information cannot be obtained from non‑vulnerable populations For incapacitated or minor participants, the trial should offer some direct benefit to the tem or to the population that they represent Ducimus ducimus mo Vulnerable populations comments Ad velit autem aut l Brief description of the study plan and design, and whenever possible, include a diagram/flow chart Discuss the expected duration of the participants' participation and a description of the sequence and duration of all the clinical trial periods, including the follow up Harum ut alias repre Study plan and design comments Sed illo qui ea quo Consider the dose(s)/dose steps, dose rationale, route of administration, schedule, treatment duration, and dose modifications Aspernatur iste quia Study treatment comments Eum dolor consequatu Comparator IMP(s) workspace Quas sint voluptatem Comparator IMP(s) comments Do aliquip quidem qu Placebo workspace Expedita et laborios Placebo comments Voluptate cupiditate Auxilliary medicinal product(s) workspace Eu sit corporis et a Auxilliary medicinal product(s) comments In sunt asperiores d Additional considerations workspace Perferendis sint qui Additional considerations comments Ea doloremque duis e Brief description of the important safety risks associated with trial treatments identified in any previous clinical trials, and as outlined in the IB or SmPC, or from another source Nesciunt velit anim Safety comments Fugiat sunt occaeca Blinding and unblinding workspace Et ab quia id proide Blinding and unblinding comments Eum suscipit omnis r Contraception measures workspace Ea consequatur Nobi Contraception measures comments Tempor id id facere Discontinuation criteria workspace Natus incidunt qui Discontinuation criteria comments Facilis eos earum q Other concomitant workspace Quo libero est tene Other concomitant comments Delectus minima qua Safety and Monitoring workspace Sunt provident eum Safety and Monitoring comments Velit numquam dolore Reference Safety Information workspace Ratione dignissimos Reference Safety Information comments Quasi cum dolores po Data Safety Monitoring Committee workspace Aliquid adipisci mai Data Safety Monitoring Committee comments Velit nemo dolor odi Definition of the end of the trial workspace Odio minima neque ap Definition of the end of the trial comments Sed quia adipisci do Biological samples used in the study workspace Enim esse ex est e Biological samples used in the study comments Officiis et delectus Data protection workspace Autem repellendus E Data protection comments Consequat Rem sit s Recruitment and informed consent procedures workspace Tempor incidunt fac Recruitment and informed consent procedures comment Rerum tenetur expedi Benefit/risk assessment workspace Sint iusto facilis Comments on the benefit/risk: Inventore provident Assessor’s overall conclusions workspace Do ducimus necessit Overall comment/ conclusion on the clinical assessment: Doloremque rerum vol 1.5.1 REQUESTS FOR ADDITIONAL INFORMATION Neque minus vel veni Study plan and design workspace Ad in dolor id deser Study plan and design comments Mollit et aspernatur Randomization and blinding workspace Nemo quasi elit dol Randomization and blinding comments Expedita maiores vit Sample size, trial power and level of significance used workspace Optio nobis nostrum Sample size, trial power and level of significance used comments Exercitation deserun Planned analysis workspace Eum odio sint iure v Planned analysis comments Iusto esse ut repre Interim analysis workspace Enim dolor deleniti Interim analysis comments Iusto qui fugiat qui Assessor’s Overall Conclusion on the Statistical Part workspace Consectetur magni ve Assessor’s Overall Conclusion on the Statistical Part comments Laboris magna id es The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study: sample ECCT/24/12/01. This approval is valid for one year and in case the study extends beyond one year from the date of this letter, you are required to seek approval before proceeding with the study. The expiry date is 7th January 2026 <ol> <li> You should ensure compliance with Kenya Legal, regulatory and GCP requirements</li> <li> All safety reports should be submitted to ECCT as per the current PPB clinical trials guidelines</li> <li> It is your responsibility to inform the PPB of any changes to the protocol, research design and procedures that could introduce new or more than minimum risk to human subjects</li> <li> You are also reminded that upon conclusion of the study, you shall be required to submit the executive summary report of the study within 30 days while a copy of the clinical study report in ICH E3 format should be submitted to us within 180 days of the study closure</li> </ol> <div> Yours Sincerely, </div> :signature :approver For Chief Executive Officer 
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 content<h3 style="text-align: center;"> <img height="86" src="https://lh7-us.googleusercontent.com/eOWVvo3AHW74GguHveDaqdgy3YwNZqOqOO0QtscRoV4hJfcvt8Q6v4oLN3beVNvClvoD1ncu1RhB5D4iuAY-5R9h1aD2lEGqUorBVcQ0azfxsdvIz-WhbF3rA9-VQomtusnP2bNZTuYLFTC6vQ46nQ" style="background-color: transparent; color: rgb(0, 0, 0); font-family: "Bookman Old Style", serif; font-size: 11pt; white-space-collapse: preserve; margin-left: 0px; margin-top: 0px;" width="116" /></h3> MINISTRY OF HEALTH PHARMACY AND POISONS BOARD <table style="width: 100%; border:0px"> <tbody> <tr> <td style="width: 33.33%; border:0px"> <div id="left-editor"> Telegram: "MINHEALTH", Nairobi Cell phone: 0709 770 100 Email: info@pharmacyboardkenya.org Website: web.pharmacyboardkenya.org </div> </td> <td style="width: 33.33%;border:0px"> </td> <td style="width: 33.33%;border:0px"> <div id="right-editor"> Pharmacy and Poisons Board House Along Lenana Road P.O. Box 27663-00506 NAIROBI </div> </td> </tr> </tbody> </table> <address> </address> <address> When replying please quote</address> Ref. No. ECCT/14/2024-ECCT/24/12/01 7 Jan 2025 Lawrence Jennings Aladdin Powers Elton Delgado, Principal Investigator ECCT/24/12/01, Ut facere ea aliquam eveniet, Dear Sir/Madam, Re: ECCT/24/12/01 : Initial Approval; sample Et eius sit aut et fugiat adi. Reference is made to the above study. We acknowledge receipt of the following documents; <div style="margin-left: 15px;"> 1. GMP certificate of the investigational product from the site of manufacture <a href="/attachments/download/1071">screenshot_from_2024_11_28_11_17_15.png</a> dated 28th November 2024 Version 5 2. Cover Letter (Should list all the submitted documents, their version numbers and dates) <a href="/attachments/download/1118">logo_46.png</a> dated 1st December 2024 Version 1 3. The Study Protocol <a href="/attachments/download/1119">logo_47.png</a> dated 2nd December 2024 Version 3 4. Registration of the study at Pan African Clinical Trials Registry https://pactr.samrc.ac.za <a href="/attachments/download/1120">logo_48.png</a> dated 10th December 2024 Version 4 5. Patient Information leaflet and Informed consent form <a href="/attachments/download/1121">logo_49.png</a> dated 1st December 2024 Version 4 6. Investigators Brochure/Package inserts <a href="/attachments/download/1122">logo_50.png</a> dated 3rd December 2024 Version 3 7. Investigational Medicinal Product Dossier (IMPD) <a href="/attachments/download/1123">logo_51.png</a> dated 2nd December 2024 Version 3 8. Adequate data and information from previous studies and Phases to support carrying out of the current study <a href="/attachments/download/1124">logo_52.png</a> dated 2nd December 2024 Version 3 9. Stability data of the investigational product <a href="/attachments/download/1125">logo_53.png</a> dated 3rd December 2024 Version 3 10. Certificate of Analysis of the investigational product <a href="/attachments/download/1126">logo_54.png</a> dated 2nd December 2024 Version 4 11. Pictorial Sample of the investigational products. This sample should include the text of the labeling to be used <a href="/attachments/download/1127">logo_55.png</a> dated 3rd December 2024 Version 4 12. Signed investigator(s) CV(s) including that of study Pharmacist (NB: The CV should include the current workload of the Principal Investigator ) <a href="/attachments/download/1128">logo_56.png</a> dated 3rd December 2024 Version 4 13. Evidence of contractual agreement between sponsor and Principal Investigator. <a href="/attachments/download/1129">logo_57.png</a> dated 2nd December 2024 Version 4 14. DSMB Charter including the composition and meeting schedule <a href="/attachments/download/1130">logo_58.png</a> dated 2nd December 2024 Version 2 15. Evidence of recent GCP training of the core study staff <a href="/attachments/download/1131">logo_59.png</a> dated 4th December 2024 Version 6 16. Detailed budget of the study <a href="/attachments/download/1132">logo_60.png</a> dated 3rd December 2024 Version 4 17. Financial declaration by Sponsor and/or PI <a href="/attachments/download/1133">logo_61.png</a> dated 10th December 2024 Version 5 18. Signed Declaration by Sponsor or Principal investigator that the study will be carried out according to the protocol and applicable laws, regulations and GCP requirements. <a href="/attachments/download/1134">logo_62.png</a> dated 3rd December 2024 Version 3 19. Indemnity cover for PI, investigators and study Pharmacist. <a href="/attachments/download/1135">logo_63.png</a> dated 3rd December 2024 Version 5 20. Clinical Trials Insurance cover for study participants <a href="/attachments/download/1136">logo_64.png</a> dated 3rd December 2024 Version 2 21. Copy of current Practice Licenses for the Investigators and study Pharmacist <a href="/attachments/download/1137">logo_65.png</a> dated 2nd December 2024 Version 2 22. Copy of favorable opinion letter from the local Ethics Review Committee (ERC). <a href="/attachments/download/1138">logo_66.png</a> dated 3rd December 2024 Version 1 23. Copy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable <a href="/attachments/download/1139">logo_67.png</a> dated 2nd December 2024 Version 1 24. For multicentre/multi-site studies, a site specific addendum for each of the proposed sites including among other things the sites’ capacity to carry out the study i.e personnel, equipment, laboratory etc <a href="/attachments/download/1140">logo_68.png</a> dated 12th December 2024 Version 5 25. Statistical Analysis Plan <a href="/attachments/download/1141">logo_69.png</a> dated 2nd December 2024 Version 1 26. Signed Checklist <a href="/attachments/download/1142">logo_70.png</a> dated 2nd December 2024 Version 2 27. Payment of fees <a href="/attachments/download/1143">logo_71.png</a> dated 2nd December 2024 Version 9 28. A signed statement by the applicant indicating that all information contained in, or referenced by, the application is complete and accurate and is not false or misleading. <a href="/attachments/download/1144">logo_72.png</a> dated 13th December 2024 Version 2 </div> After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials notes the following: 1.1 Introduction Maiores porro natus Primary pharmacodynamics comments Voluptatibus non cup Secondary pharmacodynamics comments Tenetur cillum ut nu Pharmacodynamic drug interactions comments Magni perferendis iu Pharmacokinetics comments Dolorum amet assume Absorption, Distribution, Metabolism & Excretion comments Qui eaque occaecat m Other pharmacokinetic studies comments Quaerat laboris dign Animal species selection/Study design comments Minim amet ea offic Single dose toxicity comments Voluptatem deleniti Repeat-dose toxicity comments Magnam omnis est des Genotoxicity comments Possimus sint tempo Carcinogenicity comments Repellendus Dolor i Reproductive and developmental toxicity - comments Officia dolore sit Juvenile toxicity studies comments Et aliqua Do eum qu Other studies (including enhanced PPND studies) comments Aut natus quibusdam Local tolerance comments Atque nostrum laboru Other toxicity studies comments Nostrud itaque volup Additional Considerations comments Quam eius rerum quia GLP aspects comments Voluptatibus in ex f Overall comment/ conclusion on the non-clinical assessment Eius sint ut debitis Trial category workspace Fugit obcaecati et Trial category comments Enim consequatur con Trial phase workspace Dolor dolore fuga S Trial phase comments (if in disagreement with the study phase proposed): Et debitis earum dol Therapeutic condition workspace A praesentium aut od Brief description of the disease Molestias ut aut non Brief discussion of clinical pharmacokinetic data, efficacy and safety data described in the IB from previous trials /previously investigated indications(s) for the IMP(s). Non-clinical studies may also be discussed for early or FIH clinical trials. Consideration should be given to the justification provided based on the non-clinical data, for the proposed starting dose, dose steps, and maximum exposure Anim totam molestiae Assessor’s discussion on the clinical development: Dignissimos ut qui d Consider what is new in this trial, the clinical relevance, and the medical need that the trial aims to address Illo cumque perferen Clinical Trial Rationale comments Qui quo eiusmod volu Consider if there are established primary endpoints for this type of study/indication, do they match the goals, are they validated? Consectetur et maxi Primary objectives comments Debitis sunt qui nis Secondary objectives workspace Atque nihil ea et re Secondary objectives comments Recusandae Magnam f Study population workspace Aut perferendis et q Study population comments A molestiae fugit i Take also into consideration the gender and age allocation of participants, and determine whether a specific group is excluded or underrepresented Incididunt Nam numqu Inclusion criteria comments Ea qui velit sint e Check if a justification is provided in the event that a specific group is excluded or underrepresented Applicable for registered products, consider the contraindications included in the SmPC for the investigational medical product, comparator, and auxiliary medical products Architecto molestias Exclusion criteria comments Voluptatem est id The inclusion of vulnerable population is justifiable only if this information cannot be obtained from non‑vulnerable populations For incapacitated or minor participants, the trial should offer some direct benefit to the tem or to the population that they represent Ducimus ducimus mo Vulnerable populations comments Ad velit autem aut l Brief description of the study plan and design, and whenever possible, include a diagram/flow chart Discuss the expected duration of the participants' participation and a description of the sequence and duration of all the clinical trial periods, including the follow up Harum ut alias repre Study plan and design comments Sed illo qui ea quo Consider the dose(s)/dose steps, dose rationale, route of administration, schedule, treatment duration, and dose modifications Aspernatur iste quia Study treatment comments Eum dolor consequatu Comparator IMP(s) workspace Quas sint voluptatem Comparator IMP(s) comments Do aliquip quidem qu Placebo workspace Expedita et laborios Placebo comments Voluptate cupiditate Auxilliary medicinal product(s) workspace Eu sit corporis et a Auxilliary medicinal product(s) comments In sunt asperiores d Additional considerations workspace Perferendis sint qui Additional considerations comments Ea doloremque duis e Brief description of the important safety risks associated with trial treatments identified in any previous clinical trials, and as outlined in the IB or SmPC, or from another source Nesciunt velit anim Safety comments Fugiat sunt occaeca Blinding and unblinding workspace Et ab quia id proide Blinding and unblinding comments Eum suscipit omnis r Contraception measures workspace Ea consequatur Nobi Contraception measures comments Tempor id id facere Discontinuation criteria workspace Natus incidunt qui Discontinuation criteria comments Facilis eos earum q Other concomitant workspace Quo libero est tene Other concomitant comments Delectus minima qua Safety and Monitoring workspace Sunt provident eum Safety and Monitoring comments Velit numquam dolore Reference Safety Information workspace Ratione dignissimos Reference Safety Information comments Quasi cum dolores po Data Safety Monitoring Committee workspace Aliquid adipisci mai Data Safety Monitoring Committee comments Velit nemo dolor odi Definition of the end of the trial workspace Odio minima neque ap Definition of the end of the trial comments Sed quia adipisci do Biological samples used in the study workspace Enim esse ex est e Biological samples used in the study comments Officiis et delectus Data protection workspace Autem repellendus E Data protection comments Consequat Rem sit s Recruitment and informed consent procedures workspace Tempor incidunt fac Recruitment and informed consent procedures comment Rerum tenetur expedi Benefit/risk assessment workspace Sint iusto facilis Comments on the benefit/risk: Inventore provident Assessor’s overall conclusions workspace Do ducimus necessit Overall comment/ conclusion on the clinical assessment: Doloremque rerum vol 1.5.1 REQUESTS FOR ADDITIONAL INFORMATION Neque minus vel veni Study plan and design workspace Ad in dolor id deser Study plan and design comments Mollit et aspernatur Randomization and blinding workspace Nemo quasi elit dol Randomization and blinding comments Expedita maiores vit Sample size, trial power and level of significance used workspace Optio nobis nostrum Sample size, trial power and level of significance used comments Exercitation deserun Planned analysis workspace Eum odio sint iure v Planned analysis comments Iusto esse ut repre Interim analysis workspace Enim dolor deleniti Interim analysis comments Iusto qui fugiat qui Assessor’s Overall Conclusion on the Statistical Part workspace Consectetur magni ve Assessor’s Overall Conclusion on the Statistical Part comments Laboris magna id es The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study: sample ECCT/24/12/01. This approval is valid for one year and in case the study extends beyond one year from the date of this letter, you are required to seek approval before proceeding with the study. The expiry date is 17th December 2025 <ol> <li> You should ensure compliance with Kenya Legal, regulatory and GCP requirements</li> <li> All safety reports should be submitted to ECCT as per the current PPB clinical trials guidelines</li> <li> It is your responsibility to inform the PPB of any changes to the protocol, research design and procedures that could introduce new or more than minimum risk to human subjects</li> <li> You are also reminded that upon conclusion of the study, you shall be required to submit the executive summary report of the study within 30 days while a copy of the clinical study report in ICH E3 format should be submitted to us within 180 days of the study closure</li> </ol> <div> Yours Sincerely, </div> :signature :approver For Chief Executive Officer 
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 approvermanager
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 statussubmitted
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 content<h3 style="text-align: center;"> <img height="86" src="https://lh7-us.googleusercontent.com/eOWVvo3AHW74GguHveDaqdgy3YwNZqOqOO0QtscRoV4hJfcvt8Q6v4oLN3beVNvClvoD1ncu1RhB5D4iuAY-5R9h1aD2lEGqUorBVcQ0azfxsdvIz-WhbF3rA9-VQomtusnP2bNZTuYLFTC6vQ46nQ" style="background-color: transparent; color: rgb(0, 0, 0); font-family: "Bookman Old Style", serif; font-size: 11pt; white-space-collapse: preserve; margin-left: 0px; margin-top: 0px;" width="116" /></h3> MINISTRY OF HEALTH PHARMACY AND POISONS BOARD <table style="width: 100%; border:0px"> <tbody> <tr> <td style="width: 33.33%; border:0px"> <div id="left-editor"> Telegram: "MINHEALTH", Nairobi Cell phone: 0709 770 100 Email: info@pharmacyboardkenya.org Website: web.pharmacyboardkenya.org </div> </td> <td style="width: 33.33%;border:0px"> </td> <td style="width: 33.33%;border:0px"> <div id="right-editor"> Pharmacy and Poisons Board House Along Lenana Road P.O. Box 27663-00506 NAIROBI </div> </td> </tr> </tbody> </table> <address> </address> <address> When replying please quote</address> Ref. No. ECCT/15/2024-ECCT/24/12/01 7 Jan 2025 Lawrence Jennings Aladdin Powers Elton Delgado, Principal Investigator ECCT/24/12/01, Ut facere ea aliquam eveniet, Dear Sir/Madam, Re: ECCT/24/12/01 : Initial Approval; sample Et eius sit aut et fugiat adi. Reference is made to the above study. We acknowledge receipt of the following documents; <div style="margin-left: 15px;"> 1. GMP certificate of the investigational product from the site of manufacture <a href="/attachments/download/1071">screenshot_from_2024_11_28_11_17_15.png</a> dated 28th November 2024 Version 5 2. Cover Letter (Should list all the submitted documents, their version numbers and dates) <a href="/attachments/download/1118">logo_46.png</a> dated 1st December 2024 Version 1 3. The Study Protocol <a href="/attachments/download/1119">logo_47.png</a> dated 2nd December 2024 Version 3 4. Registration of the study at Pan African Clinical Trials Registry https://pactr.samrc.ac.za <a href="/attachments/download/1120">logo_48.png</a> dated 10th December 2024 Version 4 5. Patient Information leaflet and Informed consent form <a href="/attachments/download/1121">logo_49.png</a> dated 1st December 2024 Version 4 6. Investigators Brochure/Package inserts <a href="/attachments/download/1122">logo_50.png</a> dated 3rd December 2024 Version 3 7. Investigational Medicinal Product Dossier (IMPD) <a href="/attachments/download/1123">logo_51.png</a> dated 2nd December 2024 Version 3 8. Adequate data and information from previous studies and Phases to support carrying out of the current study <a href="/attachments/download/1124">logo_52.png</a> dated 2nd December 2024 Version 3 9. Stability data of the investigational product <a href="/attachments/download/1125">logo_53.png</a> dated 3rd December 2024 Version 3 10. Certificate of Analysis of the investigational product <a href="/attachments/download/1126">logo_54.png</a> dated 2nd December 2024 Version 4 11. Pictorial Sample of the investigational products. This sample should include the text of the labeling to be used <a href="/attachments/download/1127">logo_55.png</a> dated 3rd December 2024 Version 4 12. Signed investigator(s) CV(s) including that of study Pharmacist (NB: The CV should include the current workload of the Principal Investigator ) <a href="/attachments/download/1128">logo_56.png</a> dated 3rd December 2024 Version 4 13. Evidence of contractual agreement between sponsor and Principal Investigator. <a href="/attachments/download/1129">logo_57.png</a> dated 2nd December 2024 Version 4 14. DSMB Charter including the composition and meeting schedule <a href="/attachments/download/1130">logo_58.png</a> dated 2nd December 2024 Version 2 15. Evidence of recent GCP training of the core study staff <a href="/attachments/download/1131">logo_59.png</a> dated 4th December 2024 Version 6 16. Detailed budget of the study <a href="/attachments/download/1132">logo_60.png</a> dated 3rd December 2024 Version 4 17. Financial declaration by Sponsor and/or PI <a href="/attachments/download/1133">logo_61.png</a> dated 10th December 2024 Version 5 18. Signed Declaration by Sponsor or Principal investigator that the study will be carried out according to the protocol and applicable laws, regulations and GCP requirements. <a href="/attachments/download/1134">logo_62.png</a> dated 3rd December 2024 Version 3 19. Indemnity cover for PI, investigators and study Pharmacist. <a href="/attachments/download/1135">logo_63.png</a> dated 3rd December 2024 Version 5 20. Clinical Trials Insurance cover for study participants <a href="/attachments/download/1136">logo_64.png</a> dated 3rd December 2024 Version 2 21. Copy of current Practice Licenses for the Investigators and study Pharmacist <a href="/attachments/download/1137">logo_65.png</a> dated 2nd December 2024 Version 2 22. Copy of favorable opinion letter from the local Ethics Review Committee (ERC). <a href="/attachments/download/1138">logo_66.png</a> dated 3rd December 2024 Version 1 23. Copy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable <a href="/attachments/download/1139">logo_67.png</a> dated 2nd December 2024 Version 1 24. For multicentre/multi-site studies, a site specific addendum for each of the proposed sites including among other things the sites’ capacity to carry out the study i.e personnel, equipment, laboratory etc <a href="/attachments/download/1140">logo_68.png</a> dated 12th December 2024 Version 5 25. Statistical Analysis Plan <a href="/attachments/download/1141">logo_69.png</a> dated 2nd December 2024 Version 1 26. Signed Checklist <a href="/attachments/download/1142">logo_70.png</a> dated 2nd December 2024 Version 2 27. Payment of fees <a href="/attachments/download/1143">logo_71.png</a> dated 2nd December 2024 Version 9 28. A signed statement by the applicant indicating that all information contained in, or referenced by, the application is complete and accurate and is not false or misleading. <a href="/attachments/download/1144">logo_72.png</a> dated 13th December 2024 Version 2 </div> After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials notes the following: 1.1 Introduction Maiores porro natus Primary pharmacodynamics comments Voluptatibus non cup Secondary pharmacodynamics comments Tenetur cillum ut nu Pharmacodynamic drug interactions comments Magni perferendis iu Pharmacokinetics comments Dolorum amet assume Absorption, Distribution, Metabolism & Excretion comments Qui eaque occaecat m Other pharmacokinetic studies comments Quaerat laboris dign Animal species selection/Study design comments Minim amet ea offic Single dose toxicity comments Voluptatem deleniti Repeat-dose toxicity comments Magnam omnis est des Genotoxicity comments Possimus sint tempo Carcinogenicity comments Repellendus Dolor i Reproductive and developmental toxicity - comments Officia dolore sit Juvenile toxicity studies comments Et aliqua Do eum qu Other studies (including enhanced PPND studies) comments Aut natus quibusdam Local tolerance comments Atque nostrum laboru Other toxicity studies comments Nostrud itaque volup Additional Considerations comments Quam eius rerum quia GLP aspects comments Voluptatibus in ex f Overall comment/ conclusion on the non-clinical assessment Eius sint ut debitis Trial category workspace Fugit obcaecati et Trial category comments Enim consequatur con Trial phase workspace Dolor dolore fuga S Trial phase comments (if in disagreement with the study phase proposed): Et debitis earum dol Therapeutic condition workspace A praesentium aut od Brief description of the disease Molestias ut aut non Brief discussion of clinical pharmacokinetic data, efficacy and safety data described in the IB from previous trials /previously investigated indications(s) for the IMP(s). Non-clinical studies may also be discussed for early or FIH clinical trials. Consideration should be given to the justification provided based on the non-clinical data, for the proposed starting dose, dose steps, and maximum exposure Anim totam molestiae Assessor’s discussion on the clinical development: Dignissimos ut qui d Consider what is new in this trial, the clinical relevance, and the medical need that the trial aims to address Illo cumque perferen Clinical Trial Rationale comments Qui quo eiusmod volu Consider if there are established primary endpoints for this type of study/indication, do they match the goals, are they validated? Consectetur et maxi Primary objectives comments Debitis sunt qui nis Secondary objectives workspace Atque nihil ea et re Secondary objectives comments Recusandae Magnam f Study population workspace Aut perferendis et q Study population comments A molestiae fugit i Take also into consideration the gender and age allocation of participants, and determine whether a specific group is excluded or underrepresented Incididunt Nam numqu Inclusion criteria comments Ea qui velit sint e Check if a justification is provided in the event that a specific group is excluded or underrepresented Applicable for registered products, consider the contraindications included in the SmPC for the investigational medical product, comparator, and auxiliary medical products Architecto molestias Exclusion criteria comments Voluptatem est id The inclusion of vulnerable population is justifiable only if this information cannot be obtained from non‑vulnerable populations For incapacitated or minor participants, the trial should offer some direct benefit to the tem or to the population that they represent Ducimus ducimus mo Vulnerable populations comments Ad velit autem aut l Brief description of the study plan and design, and whenever possible, include a diagram/flow chart Discuss the expected duration of the participants' participation and a description of the sequence and duration of all the clinical trial periods, including the follow up Harum ut alias repre Study plan and design comments Sed illo qui ea quo Consider the dose(s)/dose steps, dose rationale, route of administration, schedule, treatment duration, and dose modifications Aspernatur iste quia Study treatment comments Eum dolor consequatu Comparator IMP(s) workspace Quas sint voluptatem Comparator IMP(s) comments Do aliquip quidem qu Placebo workspace Expedita et laborios Placebo comments Voluptate cupiditate Auxilliary medicinal product(s) workspace Eu sit corporis et a Auxilliary medicinal product(s) comments In sunt asperiores d Additional considerations workspace Perferendis sint qui Additional considerations comments Ea doloremque duis e Brief description of the important safety risks associated with trial treatments identified in any previous clinical trials, and as outlined in the IB or SmPC, or from another source Nesciunt velit anim Safety comments Fugiat sunt occaeca Blinding and unblinding workspace Et ab quia id proide Blinding and unblinding comments Eum suscipit omnis r Contraception measures workspace Ea consequatur Nobi Contraception measures comments Tempor id id facere Discontinuation criteria workspace Natus incidunt qui Discontinuation criteria comments Facilis eos earum q Other concomitant workspace Quo libero est tene Other concomitant comments Delectus minima qua Safety and Monitoring workspace Sunt provident eum Safety and Monitoring comments Velit numquam dolore Reference Safety Information workspace Ratione dignissimos Reference Safety Information comments Quasi cum dolores po Data Safety Monitoring Committee workspace Aliquid adipisci mai Data Safety Monitoring Committee comments Velit nemo dolor odi Definition of the end of the trial workspace Odio minima neque ap Definition of the end of the trial comments Sed quia adipisci do Biological samples used in the study workspace Enim esse ex est e Biological samples used in the study comments Officiis et delectus Data protection workspace Autem repellendus E Data protection comments Consequat Rem sit s Recruitment and informed consent procedures workspace Tempor incidunt fac Recruitment and informed consent procedures comment Rerum tenetur expedi Benefit/risk assessment workspace Sint iusto facilis Comments on the benefit/risk: Inventore provident Assessor’s overall conclusions workspace Do ducimus necessit Overall comment/ conclusion on the clinical assessment: Doloremque rerum vol 1.5.1 REQUESTS FOR ADDITIONAL INFORMATION Neque minus vel veni Study plan and design workspace Ad in dolor id deser Study plan and design comments Mollit et aspernatur Randomization and blinding workspace Nemo quasi elit dol Randomization and blinding comments Expedita maiores vit Sample size, trial power and level of significance used workspace Optio nobis nostrum Sample size, trial power and level of significance used comments Exercitation deserun Planned analysis workspace Eum odio sint iure v Planned analysis comments Iusto esse ut repre Interim analysis workspace Enim dolor deleniti Interim analysis comments Iusto qui fugiat qui Assessor’s Overall Conclusion on the Statistical Part workspace Consectetur magni ve Assessor’s Overall Conclusion on the Statistical Part comments Laboris magna id es The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study: sample ECCT/24/12/01. This approval is valid for one year and in case the study extends beyond one year from the date of this letter, you are required to seek approval before proceeding with the study. The expiry date is 17th December 2025 <ol> <li> You should ensure compliance with Kenya Legal, regulatory and GCP requirements</li> <li> All safety reports should be submitted to ECCT as per the current PPB clinical trials guidelines</li> <li> It is your responsibility to inform the PPB of any changes to the protocol, research design and procedures that could introduce new or more than minimum risk to human subjects</li> <li> You are also reminded that upon conclusion of the study, you shall be required to submit the executive summary report of the study within 30 days while a copy of the clinical study report in ICH E3 format should be submitted to us within 180 days of the study closure</li> </ol> <div> Yours Sincerely, </div> :signature :approver For Chief Executive Officer 
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 content<h3 style="text-align: center;"> <img height="86" src="https://lh7-us.googleusercontent.com/eOWVvo3AHW74GguHveDaqdgy3YwNZqOqOO0QtscRoV4hJfcvt8Q6v4oLN3beVNvClvoD1ncu1RhB5D4iuAY-5R9h1aD2lEGqUorBVcQ0azfxsdvIz-WhbF3rA9-VQomtusnP2bNZTuYLFTC6vQ46nQ" style="background-color: transparent; color: rgb(0, 0, 0); font-family: "Bookman Old Style", serif; font-size: 11pt; white-space-collapse: preserve; margin-left: 0px; margin-top: 0px;" width="116" /></h3> MINISTRY OF HEALTH PHARMACY AND POISONS BOARD <table style="width: 100%; border:0px"> <tbody> <tr> <td style="width: 33.33%; border:0px"> <div id="left-editor"> Telegram: "MINHEALTH", Nairobi Cell phone: 0709 770 100 Email: info@pharmacyboardkenya.org Website: web.pharmacyboardkenya.org </div> </td> <td style="width: 33.33%;border:0px"> </td> <td style="width: 33.33%;border:0px"> <div id="right-editor"> Pharmacy and Poisons Board House Along Lenana Road P.O. Box 27663-00506 NAIROBI </div> </td> </tr> </tbody> </table> <address> </address> <address> When replying please quote</address> Ref. No. ECCT/16/2024-ECCT/24/12/01 7 Jan 2025 Lawrence Jennings Aladdin Powers Elton Delgado, Principal Investigator ECCT/24/12/01, Ut facere ea aliquam eveniet, Dear Sir/Madam, Re: ECCT/24/12/01 : Initial Approval; sample Et eius sit aut et fugiat adi. Reference is made to the above study. We acknowledge receipt of the following documents; <div style="margin-left: 15px;"> 1. GMP certificate of the investigational product from the site of manufacture <a href="/attachments/download/1071">screenshot_from_2024_11_28_11_17_15.png</a> dated 28th November 2024 Version 5 2. Cover Letter (Should list all the submitted documents, their version numbers and dates) <a href="/attachments/download/1118">logo_46.png</a> dated 1st December 2024 Version 1 3. The Study Protocol <a href="/attachments/download/1119">logo_47.png</a> dated 2nd December 2024 Version 3 4. Registration of the study at Pan African Clinical Trials Registry https://pactr.samrc.ac.za <a href="/attachments/download/1120">logo_48.png</a> dated 10th December 2024 Version 4 5. Patient Information leaflet and Informed consent form <a href="/attachments/download/1121">logo_49.png</a> dated 1st December 2024 Version 4 6. Investigators Brochure/Package inserts <a href="/attachments/download/1122">logo_50.png</a> dated 3rd December 2024 Version 3 7. Investigational Medicinal Product Dossier (IMPD) <a href="/attachments/download/1123">logo_51.png</a> dated 2nd December 2024 Version 3 8. Adequate data and information from previous studies and Phases to support carrying out of the current study <a href="/attachments/download/1124">logo_52.png</a> dated 2nd December 2024 Version 3 9. Stability data of the investigational product <a href="/attachments/download/1125">logo_53.png</a> dated 3rd December 2024 Version 3 10. Certificate of Analysis of the investigational product <a href="/attachments/download/1126">logo_54.png</a> dated 2nd December 2024 Version 4 11. Pictorial Sample of the investigational products. This sample should include the text of the labeling to be used <a href="/attachments/download/1127">logo_55.png</a> dated 3rd December 2024 Version 4 12. Signed investigator(s) CV(s) including that of study Pharmacist (NB: The CV should include the current workload of the Principal Investigator ) <a href="/attachments/download/1128">logo_56.png</a> dated 3rd December 2024 Version 4 13. Evidence of contractual agreement between sponsor and Principal Investigator. <a href="/attachments/download/1129">logo_57.png</a> dated 2nd December 2024 Version 4 14. DSMB Charter including the composition and meeting schedule <a href="/attachments/download/1130">logo_58.png</a> dated 2nd December 2024 Version 2 15. Evidence of recent GCP training of the core study staff <a href="/attachments/download/1131">logo_59.png</a> dated 4th December 2024 Version 6 16. Detailed budget of the study <a href="/attachments/download/1132">logo_60.png</a> dated 3rd December 2024 Version 4 17. Financial declaration by Sponsor and/or PI <a href="/attachments/download/1133">logo_61.png</a> dated 10th December 2024 Version 5 18. Signed Declaration by Sponsor or Principal investigator that the study will be carried out according to the protocol and applicable laws, regulations and GCP requirements. <a href="/attachments/download/1134">logo_62.png</a> dated 3rd December 2024 Version 3 19. Indemnity cover for PI, investigators and study Pharmacist. <a href="/attachments/download/1135">logo_63.png</a> dated 3rd December 2024 Version 5 20. Clinical Trials Insurance cover for study participants <a href="/attachments/download/1136">logo_64.png</a> dated 3rd December 2024 Version 2 21. Copy of current Practice Licenses for the Investigators and study Pharmacist <a href="/attachments/download/1137">logo_65.png</a> dated 2nd December 2024 Version 2 22. Copy of favorable opinion letter from the local Ethics Review Committee (ERC). <a href="/attachments/download/1138">logo_66.png</a> dated 3rd December 2024 Version 1 23. Copy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable <a href="/attachments/download/1139">logo_67.png</a> dated 2nd December 2024 Version 1 24. For multicentre/multi-site studies, a site specific addendum for each of the proposed sites including among other things the sites’ capacity to carry out the study i.e personnel, equipment, laboratory etc <a href="/attachments/download/1140">logo_68.png</a> dated 12th December 2024 Version 5 25. Statistical Analysis Plan <a href="/attachments/download/1141">logo_69.png</a> dated 2nd December 2024 Version 1 26. Signed Checklist <a href="/attachments/download/1142">logo_70.png</a> dated 2nd December 2024 Version 2 27. Payment of fees <a href="/attachments/download/1143">logo_71.png</a> dated 2nd December 2024 Version 9 28. A signed statement by the applicant indicating that all information contained in, or referenced by, the application is complete and accurate and is not false or misleading. <a href="/attachments/download/1144">logo_72.png</a> dated 13th December 2024 Version 2 </div> After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials notes the following: 1.1 Introduction Maiores porro natus Primary pharmacodynamics comments Voluptatibus non cup Secondary pharmacodynamics comments Tenetur cillum ut nu Pharmacodynamic drug interactions comments Magni perferendis iu Pharmacokinetics comments Dolorum amet assume Absorption, Distribution, Metabolism & Excretion comments Qui eaque occaecat m Other pharmacokinetic studies comments Quaerat laboris dign Animal species selection/Study design comments Minim amet ea offic Single dose toxicity comments Voluptatem deleniti Repeat-dose toxicity comments Magnam omnis est des Genotoxicity comments Possimus sint tempo Carcinogenicity comments Repellendus Dolor i Reproductive and developmental toxicity - comments Officia dolore sit Juvenile toxicity studies comments Et aliqua Do eum qu Other studies (including enhanced PPND studies) comments Aut natus quibusdam Local tolerance comments Atque nostrum laboru Other toxicity studies comments Nostrud itaque volup Additional Considerations comments Quam eius rerum quia GLP aspects comments Voluptatibus in ex f Overall comment/ conclusion on the non-clinical assessment Eius sint ut debitis Trial category workspace Fugit obcaecati et Trial category comments Enim consequatur con Trial phase workspace Dolor dolore fuga S Trial phase comments (if in disagreement with the study phase proposed): Et debitis earum dol Therapeutic condition workspace A praesentium aut od Brief description of the disease Molestias ut aut non Brief discussion of clinical pharmacokinetic data, efficacy and safety data described in the IB from previous trials /previously investigated indications(s) for the IMP(s). Non-clinical studies may also be discussed for early or FIH clinical trials. Consideration should be given to the justification provided based on the non-clinical data, for the proposed starting dose, dose steps, and maximum exposure Anim totam molestiae Assessor’s discussion on the clinical development: Dignissimos ut qui d Consider what is new in this trial, the clinical relevance, and the medical need that the trial aims to address Illo cumque perferen Clinical Trial Rationale comments Qui quo eiusmod volu Consider if there are established primary endpoints for this type of study/indication, do they match the goals, are they validated? Consectetur et maxi Primary objectives comments Debitis sunt qui nis Secondary objectives workspace Atque nihil ea et re Secondary objectives comments Recusandae Magnam f Study population workspace Aut perferendis et q Study population comments A molestiae fugit i Take also into consideration the gender and age allocation of participants, and determine whether a specific group is excluded or underrepresented Incididunt Nam numqu Inclusion criteria comments Ea qui velit sint e Check if a justification is provided in the event that a specific group is excluded or underrepresented Applicable for registered products, consider the contraindications included in the SmPC for the investigational medical product, comparator, and auxiliary medical products Architecto molestias Exclusion criteria comments Voluptatem est id The inclusion of vulnerable population is justifiable only if this information cannot be obtained from non‑vulnerable populations For incapacitated or minor participants, the trial should offer some direct benefit to the tem or to the population that they represent Ducimus ducimus mo Vulnerable populations comments Ad velit autem aut l Brief description of the study plan and design, and whenever possible, include a diagram/flow chart Discuss the expected duration of the participants' participation and a description of the sequence and duration of all the clinical trial periods, including the follow up Harum ut alias repre Study plan and design comments Sed illo qui ea quo Consider the dose(s)/dose steps, dose rationale, route of administration, schedule, treatment duration, and dose modifications Aspernatur iste quia Study treatment comments Eum dolor consequatu Comparator IMP(s) workspace Quas sint voluptatem Comparator IMP(s) comments Do aliquip quidem qu Placebo workspace Expedita et laborios Placebo comments Voluptate cupiditate Auxilliary medicinal product(s) workspace Eu sit corporis et a Auxilliary medicinal product(s) comments In sunt asperiores d Additional considerations workspace Perferendis sint qui Additional considerations comments Ea doloremque duis e Brief description of the important safety risks associated with trial treatments identified in any previous clinical trials, and as outlined in the IB or SmPC, or from another source Nesciunt velit anim Safety comments Fugiat sunt occaeca Blinding and unblinding workspace Et ab quia id proide Blinding and unblinding comments Eum suscipit omnis r Contraception measures workspace Ea consequatur Nobi Contraception measures comments Tempor id id facere Discontinuation criteria workspace Natus incidunt qui Discontinuation criteria comments Facilis eos earum q Other concomitant workspace Quo libero est tene Other concomitant comments Delectus minima qua Safety and Monitoring workspace Sunt provident eum Safety and Monitoring comments Velit numquam dolore Reference Safety Information workspace Ratione dignissimos Reference Safety Information comments Quasi cum dolores po Data Safety Monitoring Committee workspace Aliquid adipisci mai Data Safety Monitoring Committee comments Velit nemo dolor odi Definition of the end of the trial workspace Odio minima neque ap Definition of the end of the trial comments Sed quia adipisci do Biological samples used in the study workspace Enim esse ex est e Biological samples used in the study comments Officiis et delectus Data protection workspace Autem repellendus E Data protection comments Consequat Rem sit s Recruitment and informed consent procedures workspace Tempor incidunt fac Recruitment and informed consent procedures comment Rerum tenetur expedi Benefit/risk assessment workspace Sint iusto facilis Comments on the benefit/risk: Inventore provident Assessor’s overall conclusions workspace Do ducimus necessit Overall comment/ conclusion on the clinical assessment: Doloremque rerum vol 1.5.1 REQUESTS FOR ADDITIONAL INFORMATION Neque minus vel veni Study plan and design workspace Ad in dolor id deser Study plan and design comments Mollit et aspernatur Randomization and blinding workspace Nemo quasi elit dol Randomization and blinding comments Expedita maiores vit Sample size, trial power and level of significance used workspace Optio nobis nostrum Sample size, trial power and level of significance used comments Exercitation deserun Planned analysis workspace Eum odio sint iure v Planned analysis comments Iusto esse ut repre Interim analysis workspace Enim dolor deleniti Interim analysis comments Iusto qui fugiat qui Assessor’s Overall Conclusion on the Statistical Part workspace Consectetur magni ve Assessor’s Overall Conclusion on the Statistical Part comments Laboris magna id es The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study: sample ECCT/24/12/01. This approval is valid for one year and in case the study extends beyond one year from the date of this letter, you are required to seek approval before proceeding with the study. The expiry date is 17th December 2025 <ol> <li> You should ensure compliance with Kenya Legal, regulatory and GCP requirements</li> <li> All safety reports should be submitted to ECCT as per the current PPB clinical trials guidelines</li> <li> It is your responsibility to inform the PPB of any changes to the protocol, research design and procedures that could introduce new or more than minimum risk to human subjects</li> <li> You are also reminded that upon conclusion of the study, you shall be required to submit the executive summary report of the study within 30 days while a copy of the clinical study report in ICH E3 format should be submitted to us within 180 days of the study closure</li> </ol> <div> Yours Sincerely, </div> :signature :approver For Chief Executive Officer 
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 approvermanager
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 statussubmitted
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 content<h3 style="text-align: center;"> <img height="86" src="https://lh7-us.googleusercontent.com/eOWVvo3AHW74GguHveDaqdgy3YwNZqOqOO0QtscRoV4hJfcvt8Q6v4oLN3beVNvClvoD1ncu1RhB5D4iuAY-5R9h1aD2lEGqUorBVcQ0azfxsdvIz-WhbF3rA9-VQomtusnP2bNZTuYLFTC6vQ46nQ" style="background-color: transparent; color: rgb(0, 0, 0); font-family: "Bookman Old Style", serif; font-size: 11pt; white-space-collapse: preserve; margin-left: 0px; margin-top: 0px;" width="116" /></h3> MINISTRY OF HEALTH PHARMACY AND POISONS BOARD <table style="width: 100%; border:0px"> <tbody> <tr> <td style="width: 33.33%; border:0px"> <div id="left-editor"> Telegram: "MINHEALTH", Nairobi Cell phone: 0709 770 100 Email: info@pharmacyboardkenya.org Website: web.pharmacyboardkenya.org </div> </td> <td style="width: 33.33%;border:0px"> </td> <td style="width: 33.33%;border:0px"> <div id="right-editor"> Pharmacy and Poisons Board House Along Lenana Road P.O. Box 27663-00506 NAIROBI </div> </td> </tr> </tbody> </table> <address> </address> <address> When replying please quote</address> Ref. No. ECCT/17/2024-ECCT/24/12/01 7 Jan 2025 Lawrence Jennings Aladdin Powers Elton Delgado, Principal Investigator ECCT/24/12/01, Ut facere ea aliquam eveniet, Dear Sir/Madam, Re: ECCT/24/12/01 : Initial Approval; sample Et eius sit aut et fugiat adi. Reference is made to the above study. We acknowledge receipt of the following documents; <div style="margin-left: 15px;"> 1. GMP certificate of the investigational product from the site of manufacture <a href="/attachments/download/1071">screenshot_from_2024_11_28_11_17_15.png</a> dated 28th November 2024 Version 5 2. Cover Letter (Should list all the submitted documents, their version numbers and dates) <a href="/attachments/download/1118">logo_46.png</a> dated 1st December 2024 Version 1 3. The Study Protocol <a href="/attachments/download/1119">logo_47.png</a> dated 2nd December 2024 Version 3 4. Registration of the study at Pan African Clinical Trials Registry https://pactr.samrc.ac.za <a href="/attachments/download/1120">logo_48.png</a> dated 10th December 2024 Version 4 5. Patient Information leaflet and Informed consent form <a href="/attachments/download/1121">logo_49.png</a> dated 1st December 2024 Version 4 6. Investigators Brochure/Package inserts <a href="/attachments/download/1122">logo_50.png</a> dated 3rd December 2024 Version 3 7. Investigational Medicinal Product Dossier (IMPD) <a href="/attachments/download/1123">logo_51.png</a> dated 2nd December 2024 Version 3 8. Adequate data and information from previous studies and Phases to support carrying out of the current study <a href="/attachments/download/1124">logo_52.png</a> dated 2nd December 2024 Version 3 9. Stability data of the investigational product <a href="/attachments/download/1125">logo_53.png</a> dated 3rd December 2024 Version 3 10. Certificate of Analysis of the investigational product <a href="/attachments/download/1126">logo_54.png</a> dated 2nd December 2024 Version 4 11. Pictorial Sample of the investigational products. This sample should include the text of the labeling to be used <a href="/attachments/download/1127">logo_55.png</a> dated 3rd December 2024 Version 4 12. Signed investigator(s) CV(s) including that of study Pharmacist (NB: The CV should include the current workload of the Principal Investigator ) <a href="/attachments/download/1128">logo_56.png</a> dated 3rd December 2024 Version 4 13. Evidence of contractual agreement between sponsor and Principal Investigator. <a href="/attachments/download/1129">logo_57.png</a> dated 2nd December 2024 Version 4 14. DSMB Charter including the composition and meeting schedule <a href="/attachments/download/1130">logo_58.png</a> dated 2nd December 2024 Version 2 15. Evidence of recent GCP training of the core study staff <a href="/attachments/download/1131">logo_59.png</a> dated 4th December 2024 Version 6 16. Detailed budget of the study <a href="/attachments/download/1132">logo_60.png</a> dated 3rd December 2024 Version 4 17. Financial declaration by Sponsor and/or PI <a href="/attachments/download/1133">logo_61.png</a> dated 10th December 2024 Version 5 18. Signed Declaration by Sponsor or Principal investigator that the study will be carried out according to the protocol and applicable laws, regulations and GCP requirements. <a href="/attachments/download/1134">logo_62.png</a> dated 3rd December 2024 Version 3 19. Indemnity cover for PI, investigators and study Pharmacist. <a href="/attachments/download/1135">logo_63.png</a> dated 3rd December 2024 Version 5 20. Clinical Trials Insurance cover for study participants <a href="/attachments/download/1136">logo_64.png</a> dated 3rd December 2024 Version 2 21. Copy of current Practice Licenses for the Investigators and study Pharmacist <a href="/attachments/download/1137">logo_65.png</a> dated 2nd December 2024 Version 2 22. Copy of favorable opinion letter from the local Ethics Review Committee (ERC). <a href="/attachments/download/1138">logo_66.png</a> dated 3rd December 2024 Version 1 23. Copy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable <a href="/attachments/download/1139">logo_67.png</a> dated 2nd December 2024 Version 1 24. For multicentre/multi-site studies, a site specific addendum for each of the proposed sites including among other things the sites’ capacity to carry out the study i.e personnel, equipment, laboratory etc <a href="/attachments/download/1140">logo_68.png</a> dated 12th December 2024 Version 5 25. Statistical Analysis Plan <a href="/attachments/download/1141">logo_69.png</a> dated 2nd December 2024 Version 1 26. Signed Checklist <a href="/attachments/download/1142">logo_70.png</a> dated 2nd December 2024 Version 2 27. Payment of fees <a href="/attachments/download/1143">logo_71.png</a> dated 2nd December 2024 Version 9 28. A signed statement by the applicant indicating that all information contained in, or referenced by, the application is complete and accurate and is not false or misleading. <a href="/attachments/download/1144">logo_72.png</a> dated 13th December 2024 Version 2 </div> After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials notes the following: 1.1 Introduction Maiores porro natus Primary pharmacodynamics comments Voluptatibus non cup Secondary pharmacodynamics comments Tenetur cillum ut nu Pharmacodynamic drug interactions comments Magni perferendis iu Pharmacokinetics comments Dolorum amet assume Absorption, Distribution, Metabolism & Excretion comments Qui eaque occaecat m Other pharmacokinetic studies comments Quaerat laboris dign Animal species selection/Study design comments Minim amet ea offic Single dose toxicity comments Voluptatem deleniti Repeat-dose toxicity comments Magnam omnis est des Genotoxicity comments Possimus sint tempo Carcinogenicity comments Repellendus Dolor i Reproductive and developmental toxicity - comments Officia dolore sit Juvenile toxicity studies comments Et aliqua Do eum qu Other studies (including enhanced PPND studies) comments Aut natus quibusdam Local tolerance comments Atque nostrum laboru Other toxicity studies comments Nostrud itaque volup Additional Considerations comments Quam eius rerum quia GLP aspects comments Voluptatibus in ex f Overall comment/ conclusion on the non-clinical assessment Eius sint ut debitis Trial category workspace Fugit obcaecati et Trial category comments Enim consequatur con Trial phase workspace Dolor dolore fuga S Trial phase comments (if in disagreement with the study phase proposed): Et debitis earum dol Therapeutic condition workspace A praesentium aut od Brief description of the disease Molestias ut aut non Brief discussion of clinical pharmacokinetic data, efficacy and safety data described in the IB from previous trials /previously investigated indications(s) for the IMP(s). Non-clinical studies may also be discussed for early or FIH clinical trials. Consideration should be given to the justification provided based on the non-clinical data, for the proposed starting dose, dose steps, and maximum exposure Anim totam molestiae Assessor’s discussion on the clinical development: Dignissimos ut qui d Consider what is new in this trial, the clinical relevance, and the medical need that the trial aims to address Illo cumque perferen Clinical Trial Rationale comments Qui quo eiusmod volu Consider if there are established primary endpoints for this type of study/indication, do they match the goals, are they validated? Consectetur et maxi Primary objectives comments Debitis sunt qui nis Secondary objectives workspace Atque nihil ea et re Secondary objectives comments Recusandae Magnam f Study population workspace Aut perferendis et q Study population comments A molestiae fugit i Take also into consideration the gender and age allocation of participants, and determine whether a specific group is excluded or underrepresented Incididunt Nam numqu Inclusion criteria comments Ea qui velit sint e Check if a justification is provided in the event that a specific group is excluded or underrepresented Applicable for registered products, consider the contraindications included in the SmPC for the investigational medical product, comparator, and auxiliary medical products Architecto molestias Exclusion criteria comments Voluptatem est id The inclusion of vulnerable population is justifiable only if this information cannot be obtained from non‑vulnerable populations For incapacitated or minor participants, the trial should offer some direct benefit to the tem or to the population that they represent Ducimus ducimus mo Vulnerable populations comments Ad velit autem aut l Brief description of the study plan and design, and whenever possible, include a diagram/flow chart Discuss the expected duration of the participants' participation and a description of the sequence and duration of all the clinical trial periods, including the follow up Harum ut alias repre Study plan and design comments Sed illo qui ea quo Consider the dose(s)/dose steps, dose rationale, route of administration, schedule, treatment duration, and dose modifications Aspernatur iste quia Study treatment comments Eum dolor consequatu Comparator IMP(s) workspace Quas sint voluptatem Comparator IMP(s) comments Do aliquip quidem qu Placebo workspace Expedita et laborios Placebo comments Voluptate cupiditate Auxilliary medicinal product(s) workspace Eu sit corporis et a Auxilliary medicinal product(s) comments In sunt asperiores d Additional considerations workspace Perferendis sint qui Additional considerations comments Ea doloremque duis e Brief description of the important safety risks associated with trial treatments identified in any previous clinical trials, and as outlined in the IB or SmPC, or from another source Nesciunt velit anim Safety comments Fugiat sunt occaeca Blinding and unblinding workspace Et ab quia id proide Blinding and unblinding comments Eum suscipit omnis r Contraception measures workspace Ea consequatur Nobi Contraception measures comments Tempor id id facere Discontinuation criteria workspace Natus incidunt qui Discontinuation criteria comments Facilis eos earum q Other concomitant workspace Quo libero est tene Other concomitant comments Delectus minima qua Safety and Monitoring workspace Sunt provident eum Safety and Monitoring comments Velit numquam dolore Reference Safety Information workspace Ratione dignissimos Reference Safety Information comments Quasi cum dolores po Data Safety Monitoring Committee workspace Aliquid adipisci mai Data Safety Monitoring Committee comments Velit nemo dolor odi Definition of the end of the trial workspace Odio minima neque ap Definition of the end of the trial comments Sed quia adipisci do Biological samples used in the study workspace Enim esse ex est e Biological samples used in the study comments Officiis et delectus Data protection workspace Autem repellendus E Data protection comments Consequat Rem sit s Recruitment and informed consent procedures workspace Tempor incidunt fac Recruitment and informed consent procedures comment Rerum tenetur expedi Benefit/risk assessment workspace Sint iusto facilis Comments on the benefit/risk: Inventore provident Assessor’s overall conclusions workspace Do ducimus necessit Overall comment/ conclusion on the clinical assessment: Doloremque rerum vol 1.5.1 REQUESTS FOR ADDITIONAL INFORMATION Neque minus vel veni Study plan and design workspace Ad in dolor id deser Study plan and design comments Mollit et aspernatur Randomization and blinding workspace Nemo quasi elit dol Randomization and blinding comments Expedita maiores vit Sample size, trial power and level of significance used workspace Optio nobis nostrum Sample size, trial power and level of significance used comments Exercitation deserun Planned analysis workspace Eum odio sint iure v Planned analysis comments Iusto esse ut repre Interim analysis workspace Enim dolor deleniti Interim analysis comments Iusto qui fugiat qui Assessor’s Overall Conclusion on the Statistical Part workspace Consectetur magni ve Assessor’s Overall Conclusion on the Statistical Part comments Laboris magna id es The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study: sample ECCT/24/12/01. This approval is valid for one year and in case the study extends beyond one year from the date of this letter, you are required to seek approval before proceeding with the study. The expiry date is 17th December 2025 <ol> <li> You should ensure compliance with Kenya Legal, regulatory and GCP requirements</li> <li> All safety reports should be submitted to ECCT as per the current PPB clinical trials guidelines</li> <li> It is your responsibility to inform the PPB of any changes to the protocol, research design and procedures that could introduce new or more than minimum risk to human subjects</li> <li> You are also reminded that upon conclusion of the study, you shall be required to submit the executive summary report of the study within 30 days while a copy of the clinical study report in ICH E3 format should be submitted to us within 180 days of the study closure</li> </ol> <div> Yours Sincerely, </div> :signature :approver For Chief Executive Officer 
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 content<h3 style="text-align: center;"> <img height="86" src="https://lh7-us.googleusercontent.com/eOWVvo3AHW74GguHveDaqdgy3YwNZqOqOO0QtscRoV4hJfcvt8Q6v4oLN3beVNvClvoD1ncu1RhB5D4iuAY-5R9h1aD2lEGqUorBVcQ0azfxsdvIz-WhbF3rA9-VQomtusnP2bNZTuYLFTC6vQ46nQ" style="background-color: transparent; color: rgb(0, 0, 0); font-family: "Bookman Old Style", serif; font-size: 11pt; white-space-collapse: preserve; margin-left: 0px; margin-top: 0px;" width="116" /></h3> MINISTRY OF HEALTH PHARMACY AND POISONS BOARD <table style="width: 100%; border:0px"> <tbody> <tr> <td style="width: 33.33%; border:0px"> <div id="left-editor"> Telegram: "MINHEALTH", Nairobi Cell phone: 0709 770 100 Email: info@pharmacyboardkenya.org Website: web.pharmacyboardkenya.org </div> </td> <td style="width: 33.33%;border:0px"> </td> <td style="width: 33.33%;border:0px"> <div id="right-editor"> Pharmacy and Poisons Board House Along Lenana Road P.O. Box 27663-00506 NAIROBI </div> </td> </tr> </tbody> </table> <address> </address> <address> When replying please quote</address> Ref. No. ECCT/18/2024-ECCT/24/12/01 7 Jan 2025 Lawrence Jennings Aladdin Powers Elton Delgado, Principal Investigator ECCT/24/12/01, Ut facere ea aliquam eveniet, Dear Sir/Madam, Re: ECCT/24/12/01 : Initial Approval; sample Et eius sit aut et fugiat adi. Reference is made to the above study. We acknowledge receipt of the following documents; <div style="margin-left: 15px;"> 1. GMP certificate of the investigational product from the site of manufacture <a href="/attachments/download/1071">screenshot_from_2024_11_28_11_17_15.png</a> dated 28th November 2024 Version 5 2. Cover Letter (Should list all the submitted documents, their version numbers and dates) <a href="/attachments/download/1118">logo_46.png</a> dated 1st December 2024 Version 1 3. The Study Protocol <a href="/attachments/download/1119">logo_47.png</a> dated 2nd December 2024 Version 3 4. Registration of the study at Pan African Clinical Trials Registry https://pactr.samrc.ac.za <a href="/attachments/download/1120">logo_48.png</a> dated 10th December 2024 Version 4 5. Patient Information leaflet and Informed consent form <a href="/attachments/download/1121">logo_49.png</a> dated 1st December 2024 Version 4 6. Investigators Brochure/Package inserts <a href="/attachments/download/1122">logo_50.png</a> dated 3rd December 2024 Version 3 7. Investigational Medicinal Product Dossier (IMPD) <a href="/attachments/download/1123">logo_51.png</a> dated 2nd December 2024 Version 3 8. Adequate data and information from previous studies and Phases to support carrying out of the current study <a href="/attachments/download/1124">logo_52.png</a> dated 2nd December 2024 Version 3 9. Stability data of the investigational product <a href="/attachments/download/1125">logo_53.png</a> dated 3rd December 2024 Version 3 10. Certificate of Analysis of the investigational product <a href="/attachments/download/1126">logo_54.png</a> dated 2nd December 2024 Version 4 11. Pictorial Sample of the investigational products. This sample should include the text of the labeling to be used <a href="/attachments/download/1127">logo_55.png</a> dated 3rd December 2024 Version 4 12. Signed investigator(s) CV(s) including that of study Pharmacist (NB: The CV should include the current workload of the Principal Investigator ) <a href="/attachments/download/1128">logo_56.png</a> dated 3rd December 2024 Version 4 13. Evidence of contractual agreement between sponsor and Principal Investigator. <a href="/attachments/download/1129">logo_57.png</a> dated 2nd December 2024 Version 4 14. DSMB Charter including the composition and meeting schedule <a href="/attachments/download/1130">logo_58.png</a> dated 2nd December 2024 Version 2 15. Evidence of recent GCP training of the core study staff <a href="/attachments/download/1131">logo_59.png</a> dated 4th December 2024 Version 6 16. Detailed budget of the study <a href="/attachments/download/1132">logo_60.png</a> dated 3rd December 2024 Version 4 17. Financial declaration by Sponsor and/or PI <a href="/attachments/download/1133">logo_61.png</a> dated 10th December 2024 Version 5 18. Signed Declaration by Sponsor or Principal investigator that the study will be carried out according to the protocol and applicable laws, regulations and GCP requirements. <a href="/attachments/download/1134">logo_62.png</a> dated 3rd December 2024 Version 3 19. Indemnity cover for PI, investigators and study Pharmacist. <a href="/attachments/download/1135">logo_63.png</a> dated 3rd December 2024 Version 5 20. Clinical Trials Insurance cover for study participants <a href="/attachments/download/1136">logo_64.png</a> dated 3rd December 2024 Version 2 21. Copy of current Practice Licenses for the Investigators and study Pharmacist <a href="/attachments/download/1137">logo_65.png</a> dated 2nd December 2024 Version 2 22. Copy of favorable opinion letter from the local Ethics Review Committee (ERC). <a href="/attachments/download/1138">logo_66.png</a> dated 3rd December 2024 Version 1 23. Copy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable <a href="/attachments/download/1139">logo_67.png</a> dated 2nd December 2024 Version 1 24. For multicentre/multi-site studies, a site specific addendum for each of the proposed sites including among other things the sites’ capacity to carry out the study i.e personnel, equipment, laboratory etc <a href="/attachments/download/1140">logo_68.png</a> dated 12th December 2024 Version 5 25. Statistical Analysis Plan <a href="/attachments/download/1141">logo_69.png</a> dated 2nd December 2024 Version 1 26. Signed Checklist <a href="/attachments/download/1142">logo_70.png</a> dated 2nd December 2024 Version 2 27. Payment of fees <a href="/attachments/download/1143">logo_71.png</a> dated 2nd December 2024 Version 9 28. A signed statement by the applicant indicating that all information contained in, or referenced by, the application is complete and accurate and is not false or misleading. <a href="/attachments/download/1144">logo_72.png</a> dated 13th December 2024 Version 2 </div> After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials notes the following: 1.1 Introduction Maiores porro natus Primary pharmacodynamics comments Voluptatibus non cup Secondary pharmacodynamics comments Tenetur cillum ut nu Pharmacodynamic drug interactions comments Magni perferendis iu Pharmacokinetics comments Dolorum amet assume Absorption, Distribution, Metabolism & Excretion comments Qui eaque occaecat m Other pharmacokinetic studies comments Quaerat laboris dign Animal species selection/Study design comments Minim amet ea offic Single dose toxicity comments Voluptatem deleniti Repeat-dose toxicity comments Magnam omnis est des Genotoxicity comments Possimus sint tempo Carcinogenicity comments Repellendus Dolor i Reproductive and developmental toxicity - comments Officia dolore sit Juvenile toxicity studies comments Et aliqua Do eum qu Other studies (including enhanced PPND studies) comments Aut natus quibusdam Local tolerance comments Atque nostrum laboru Other toxicity studies comments Nostrud itaque volup Additional Considerations comments Quam eius rerum quia GLP aspects comments Voluptatibus in ex f Overall comment/ conclusion on the non-clinical assessment Eius sint ut debitis Trial category workspace Fugit obcaecati et Trial category comments Enim consequatur con Trial phase workspace Dolor dolore fuga S Trial phase comments (if in disagreement with the study phase proposed): Et debitis earum dol Therapeutic condition workspace A praesentium aut od Brief description of the disease Molestias ut aut non Brief discussion of clinical pharmacokinetic data, efficacy and safety data described in the IB from previous trials /previously investigated indications(s) for the IMP(s). Non-clinical studies may also be discussed for early or FIH clinical trials. Consideration should be given to the justification provided based on the non-clinical data, for the proposed starting dose, dose steps, and maximum exposure Anim totam molestiae Assessor’s discussion on the clinical development: Dignissimos ut qui d Consider what is new in this trial, the clinical relevance, and the medical need that the trial aims to address Illo cumque perferen Clinical Trial Rationale comments Qui quo eiusmod volu Consider if there are established primary endpoints for this type of study/indication, do they match the goals, are they validated? Consectetur et maxi Primary objectives comments Debitis sunt qui nis Secondary objectives workspace Atque nihil ea et re Secondary objectives comments Recusandae Magnam f Study population workspace Aut perferendis et q Study population comments A molestiae fugit i Take also into consideration the gender and age allocation of participants, and determine whether a specific group is excluded or underrepresented Incididunt Nam numqu Inclusion criteria comments Ea qui velit sint e Check if a justification is provided in the event that a specific group is excluded or underrepresented Applicable for registered products, consider the contraindications included in the SmPC for the investigational medical product, comparator, and auxiliary medical products Architecto molestias Exclusion criteria comments Voluptatem est id The inclusion of vulnerable population is justifiable only if this information cannot be obtained from non‑vulnerable populations For incapacitated or minor participants, the trial should offer some direct benefit to the tem or to the population that they represent Ducimus ducimus mo Vulnerable populations comments Ad velit autem aut l Brief description of the study plan and design, and whenever possible, include a diagram/flow chart Discuss the expected duration of the participants' participation and a description of the sequence and duration of all the clinical trial periods, including the follow up Harum ut alias repre Study plan and design comments Sed illo qui ea quo Consider the dose(s)/dose steps, dose rationale, route of administration, schedule, treatment duration, and dose modifications Aspernatur iste quia Study treatment comments Eum dolor consequatu Comparator IMP(s) workspace Quas sint voluptatem Comparator IMP(s) comments Do aliquip quidem qu Placebo workspace Expedita et laborios Placebo comments Voluptate cupiditate Auxilliary medicinal product(s) workspace Eu sit corporis et a Auxilliary medicinal product(s) comments In sunt asperiores d Additional considerations workspace Perferendis sint qui Additional considerations comments Ea doloremque duis e Brief description of the important safety risks associated with trial treatments identified in any previous clinical trials, and as outlined in the IB or SmPC, or from another source Nesciunt velit anim Safety comments Fugiat sunt occaeca Blinding and unblinding workspace Et ab quia id proide Blinding and unblinding comments Eum suscipit omnis r Contraception measures workspace Ea consequatur Nobi Contraception measures comments Tempor id id facere Discontinuation criteria workspace Natus incidunt qui Discontinuation criteria comments Facilis eos earum q Other concomitant workspace Quo libero est tene Other concomitant comments Delectus minima qua Safety and Monitoring workspace Sunt provident eum Safety and Monitoring comments Velit numquam dolore Reference Safety Information workspace Ratione dignissimos Reference Safety Information comments Quasi cum dolores po Data Safety Monitoring Committee workspace Aliquid adipisci mai Data Safety Monitoring Committee comments Velit nemo dolor odi Definition of the end of the trial workspace Odio minima neque ap Definition of the end of the trial comments Sed quia adipisci do Biological samples used in the study workspace Enim esse ex est e Biological samples used in the study comments Officiis et delectus Data protection workspace Autem repellendus E Data protection comments Consequat Rem sit s Recruitment and informed consent procedures workspace Tempor incidunt fac Recruitment and informed consent procedures comment Rerum tenetur expedi Benefit/risk assessment workspace Sint iusto facilis Comments on the benefit/risk: Inventore provident Assessor’s overall conclusions workspace Do ducimus necessit Overall comment/ conclusion on the clinical assessment: Doloremque rerum vol 1.5.1 REQUESTS FOR ADDITIONAL INFORMATION Neque minus vel veni Study plan and design workspace Ad in dolor id deser Study plan and design comments Mollit et aspernatur Randomization and blinding workspace Nemo quasi elit dol Randomization and blinding comments Expedita maiores vit Sample size, trial power and level of significance used workspace Optio nobis nostrum Sample size, trial power and level of significance used comments Exercitation deserun Planned analysis workspace Eum odio sint iure v Planned analysis comments Iusto esse ut repre Interim analysis workspace Enim dolor deleniti Interim analysis comments Iusto qui fugiat qui Assessor’s Overall Conclusion on the Statistical Part workspace Consectetur magni ve Assessor’s Overall Conclusion on the Statistical Part comments Laboris magna id es The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study: sample ECCT/24/12/01. This approval is valid for one year and in case the study extends beyond one year from the date of this letter, you are required to seek approval before proceeding with the study. The expiry date is 17th December 2025 <ol> <li> You should ensure compliance with Kenya Legal, regulatory and GCP requirements</li> <li> All safety reports should be submitted to ECCT as per the current PPB clinical trials guidelines</li> <li> It is your responsibility to inform the PPB of any changes to the protocol, research design and procedures that could introduce new or more than minimum risk to human subjects</li> <li> You are also reminded that upon conclusion of the study, you shall be required to submit the executive summary report of the study within 30 days while a copy of the clinical study report in ICH E3 format should be submitted to us within 180 days of the study closure</li> </ol> <div> Yours Sincerely, </div> :signature :approver For Chief Executive Officer 
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 approvermanager
 approval_date07-01-2025
 expiry_date07-01-2026
 statussubmitted
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 content<h3 style="text-align: center;"> <img height="86" src="https://lh7-us.googleusercontent.com/eOWVvo3AHW74GguHveDaqdgy3YwNZqOqOO0QtscRoV4hJfcvt8Q6v4oLN3beVNvClvoD1ncu1RhB5D4iuAY-5R9h1aD2lEGqUorBVcQ0azfxsdvIz-WhbF3rA9-VQomtusnP2bNZTuYLFTC6vQ46nQ" style="background-color: transparent; color: rgb(0, 0, 0); font-family: "Bookman Old Style", serif; font-size: 11pt; white-space-collapse: preserve; margin-left: 0px; margin-top: 0px;" width="116" /></h3> MINISTRY OF HEALTH PHARMACY AND POISONS BOARD <table style="width: 100%; border:0px"> <tbody> <tr> <td style="width: 33.33%; border:0px"> <div id="left-editor"> Telegram: "MINHEALTH", Nairobi Cell phone: 0709 770 100 Email: info@pharmacyboardkenya.org Website: web.pharmacyboardkenya.org </div> </td> <td style="width: 33.33%;border:0px"> </td> <td style="width: 33.33%;border:0px"> <div id="right-editor"> Pharmacy and Poisons Board House Along Lenana Road P.O. Box 27663-00506 NAIROBI </div> </td> </tr> </tbody> </table> <address> </address> <address> When replying please quote</address> Ref. No. ECCT/19/2024-ECCT/24/12/01 7 Jan 2025 Lawrence Jennings Aladdin Powers Elton Delgado, Principal Investigator ECCT/24/12/01, Ut facere ea aliquam eveniet, Dear Sir/Madam, Re: ECCT/24/12/01 : Initial Approval; sample Et eius sit aut et fugiat adi. Reference is made to the above study. We acknowledge receipt of the following documents; <div style="margin-left: 15px;"> 1. GMP certificate of the investigational product from the site of manufacture <a href="/attachments/download/1071">screenshot_from_2024_11_28_11_17_15.png</a> dated 28th November 2024 Version 5 2. Cover Letter (Should list all the submitted documents, their version numbers and dates) <a href="/attachments/download/1118">logo_46.png</a> dated 1st December 2024 Version 1 3. The Study Protocol <a href="/attachments/download/1119">logo_47.png</a> dated 2nd December 2024 Version 3 4. Registration of the study at Pan African Clinical Trials Registry https://pactr.samrc.ac.za <a href="/attachments/download/1120">logo_48.png</a> dated 10th December 2024 Version 4 5. Patient Information leaflet and Informed consent form <a href="/attachments/download/1121">logo_49.png</a> dated 1st December 2024 Version 4 6. Investigators Brochure/Package inserts <a href="/attachments/download/1122">logo_50.png</a> dated 3rd December 2024 Version 3 7. Investigational Medicinal Product Dossier (IMPD) <a href="/attachments/download/1123">logo_51.png</a> dated 2nd December 2024 Version 3 8. Adequate data and information from previous studies and Phases to support carrying out of the current study <a href="/attachments/download/1124">logo_52.png</a> dated 2nd December 2024 Version 3 9. Stability data of the investigational product <a href="/attachments/download/1125">logo_53.png</a> dated 3rd December 2024 Version 3 10. Certificate of Analysis of the investigational product <a href="/attachments/download/1126">logo_54.png</a> dated 2nd December 2024 Version 4 11. Pictorial Sample of the investigational products. This sample should include the text of the labeling to be used <a href="/attachments/download/1127">logo_55.png</a> dated 3rd December 2024 Version 4 12. Signed investigator(s) CV(s) including that of study Pharmacist (NB: The CV should include the current workload of the Principal Investigator ) <a href="/attachments/download/1128">logo_56.png</a> dated 3rd December 2024 Version 4 13. Evidence of contractual agreement between sponsor and Principal Investigator. <a href="/attachments/download/1129">logo_57.png</a> dated 2nd December 2024 Version 4 14. DSMB Charter including the composition and meeting schedule <a href="/attachments/download/1130">logo_58.png</a> dated 2nd December 2024 Version 2 15. Evidence of recent GCP training of the core study staff <a href="/attachments/download/1131">logo_59.png</a> dated 4th December 2024 Version 6 16. Detailed budget of the study <a href="/attachments/download/1132">logo_60.png</a> dated 3rd December 2024 Version 4 17. Financial declaration by Sponsor and/or PI <a href="/attachments/download/1133">logo_61.png</a> dated 10th December 2024 Version 5 18. Signed Declaration by Sponsor or Principal investigator that the study will be carried out according to the protocol and applicable laws, regulations and GCP requirements. <a href="/attachments/download/1134">logo_62.png</a> dated 3rd December 2024 Version 3 19. Indemnity cover for PI, investigators and study Pharmacist. <a href="/attachments/download/1135">logo_63.png</a> dated 3rd December 2024 Version 5 20. Clinical Trials Insurance cover for study participants <a href="/attachments/download/1136">logo_64.png</a> dated 3rd December 2024 Version 2 21. Copy of current Practice Licenses for the Investigators and study Pharmacist <a href="/attachments/download/1137">logo_65.png</a> dated 2nd December 2024 Version 2 22. Copy of favorable opinion letter from the local Ethics Review Committee (ERC). <a href="/attachments/download/1138">logo_66.png</a> dated 3rd December 2024 Version 1 23. Copy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable <a href="/attachments/download/1139">logo_67.png</a> dated 2nd December 2024 Version 1 24. For multicentre/multi-site studies, a site specific addendum for each of the proposed sites including among other things the sites’ capacity to carry out the study i.e personnel, equipment, laboratory etc <a href="/attachments/download/1140">logo_68.png</a> dated 12th December 2024 Version 5 25. Statistical Analysis Plan <a href="/attachments/download/1141">logo_69.png</a> dated 2nd December 2024 Version 1 26. Signed Checklist <a href="/attachments/download/1142">logo_70.png</a> dated 2nd December 2024 Version 2 27. Payment of fees <a href="/attachments/download/1143">logo_71.png</a> dated 2nd December 2024 Version 9 28. A signed statement by the applicant indicating that all information contained in, or referenced by, the application is complete and accurate and is not false or misleading. <a href="/attachments/download/1144">logo_72.png</a> dated 13th December 2024 Version 2</div> After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials notes the following: 1.1 Introduction Maiores porro natus Primary pharmacodynamics comments Voluptatibus non cup Secondary pharmacodynamics comments Tenetur cillum ut nu Pharmacodynamic drug interactions comments Magni perferendis iu Pharmacokinetics comments Dolorum amet assume Absorption, Distribution, Metabolism & Excretion comments Qui eaque occaecat m Other pharmacokinetic studies comments Quaerat laboris dign Animal species selection/Study design comments Minim amet ea offic Single dose toxicity comments Voluptatem deleniti Repeat-dose toxicity comments Magnam omnis est des Genotoxicity comments Possimus sint tempo Carcinogenicity comments Repellendus Dolor i Reproductive and developmental toxicity - comments Officia dolore sit Juvenile toxicity studies comments Et aliqua Do eum qu Other studies (including enhanced PPND studies) comments Aut natus quibusdam Local tolerance comments Atque nostrum laboru Other toxicity studies comments Nostrud itaque volup Additional Considerations comments Quam eius rerum quia GLP aspects comments Voluptatibus in ex f Overall comment/ conclusion on the non-clinical assessment Eius sint ut debitis Trial category workspace Fugit obcaecati et Trial category comments Enim consequatur con Trial phase workspace Dolor dolore fuga S Trial phase comments (if in disagreement with the study phase proposed): Et debitis earum dol Therapeutic condition workspace A praesentium aut od Brief description of the disease Molestias ut aut non Brief discussion of clinical pharmacokinetic data, efficacy and safety data described in the IB from previous trials /previously investigated indications(s) for the IMP(s). Non-clinical studies may also be discussed for early or FIH clinical trials. Consideration should be given to the justification provided based on the non-clinical data, for the proposed starting dose, dose steps, and maximum exposure Anim totam molestiae Assessor’s discussion on the clinical development: Dignissimos ut qui d Consider what is new in this trial, the clinical relevance, and the medical need that the trial aims to address Illo cumque perferen Clinical Trial Rationale comments Qui quo eiusmod volu Consider if there are established primary endpoints for this type of study/indication, do they match the goals, are they validated? Consectetur et maxi Primary objectives comments Debitis sunt qui nis Secondary objectives workspace Atque nihil ea et re Secondary objectives comments Recusandae Magnam f Study population workspace Aut perferendis et q Study population comments A molestiae fugit i Take also into consideration the gender and age allocation of participants, and determine whether a specific group is excluded or underrepresented Incididunt Nam numqu Inclusion criteria comments Ea qui velit sint e Check if a justification is provided in the event that a specific group is excluded or underrepresented Applicable for registered products, consider the contraindications included in the SmPC for the investigational medical product, comparator, and auxiliary medical products Architecto molestias Exclusion criteria comments Voluptatem est id The inclusion of vulnerable population is justifiable only if this information cannot be obtained from non‑vulnerable populations For incapacitated or minor participants, the trial should offer some direct benefit to the tem or to the population that they represent Ducimus ducimus mo Vulnerable populations comments Ad velit autem aut l Brief description of the study plan and design, and whenever possible, include a diagram/flow chart Discuss the expected duration of the participants' participation and a description of the sequence and duration of all the clinical trial periods, including the follow up Harum ut alias repre Study plan and design comments Sed illo qui ea quo Consider the dose(s)/dose steps, dose rationale, route of administration, schedule, treatment duration, and dose modifications Aspernatur iste quia Study treatment comments Eum dolor consequatu Comparator IMP(s) workspace Quas sint voluptatem Comparator IMP(s) comments Do aliquip quidem qu Placebo workspace Expedita et laborios Placebo comments Voluptate cupiditate Auxilliary medicinal product(s) workspace Eu sit corporis et a Auxilliary medicinal product(s) comments In sunt asperiores d Additional considerations workspace Perferendis sint qui Additional considerations comments Ea doloremque duis e Brief description of the important safety risks associated with trial treatments identified in any previous clinical trials, and as outlined in the IB or SmPC, or from another source Nesciunt velit anim Safety comments Fugiat sunt occaeca Blinding and unblinding workspace Et ab quia id proide Blinding and unblinding comments Eum suscipit omnis r Contraception measures workspace Ea consequatur Nobi Contraception measures comments Tempor id id facere Discontinuation criteria workspace Natus incidunt qui Discontinuation criteria comments Facilis eos earum q Other concomitant workspace Quo libero est tene Other concomitant comments Delectus minima qua Safety and Monitoring workspace Sunt provident eum Safety and Monitoring comments Velit numquam dolore Reference Safety Information workspace Ratione dignissimos Reference Safety Information comments Quasi cum dolores po Data Safety Monitoring Committee workspace Aliquid adipisci mai Data Safety Monitoring Committee comments Velit nemo dolor odi Definition of the end of the trial workspace Odio minima neque ap Definition of the end of the trial comments Sed quia adipisci do Biological samples used in the study workspace Enim esse ex est e Biological samples used in the study comments Officiis et delectus Data protection workspace Autem repellendus E Data protection comments Consequat Rem sit s Recruitment and informed consent procedures workspace Tempor incidunt fac Recruitment and informed consent procedures comment Rerum tenetur expedi Benefit/risk assessment workspace Sint iusto facilis Comments on the benefit/risk: Inventore provident Assessor’s overall conclusions workspace Do ducimus necessit Overall comment/ conclusion on the clinical assessment: Doloremque rerum vol 1.5.1 REQUESTS FOR ADDITIONAL INFORMATION Neque minus vel veni Study plan and design workspace Ad in dolor id deser Study plan and design comments Mollit et aspernatur Randomization and blinding workspace Nemo quasi elit dol Randomization and blinding comments Expedita maiores vit Sample size, trial power and level of significance used workspace Optio nobis nostrum Sample size, trial power and level of significance used comments Exercitation deserun Planned analysis workspace Eum odio sint iure v Planned analysis comments Iusto esse ut repre Interim analysis workspace Enim dolor deleniti Interim analysis comments Iusto qui fugiat qui Assessor’s Overall Conclusion on the Statistical Part workspace Consectetur magni ve Assessor’s Overall Conclusion on the Statistical Part comments Laboris magna id es The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study: sample ECCT/24/12/01. This approval is valid for one year and in case the study extends beyond one year from the date of this letter, you are required to seek approval before proceeding with the study. The expiry date is 17th December 2025 <ol> <li> You should ensure compliance with Kenya Legal, regulatory and GCP requirements</li> <li> All safety reports should be submitted to ECCT as per the current PPB clinical trials guidelines</li> <li> It is your responsibility to inform the PPB of any changes to the protocol, research design and procedures that could introduce new or more than minimum risk to human subjects</li> <li> You are also reminded that upon conclusion of the study, you shall be required to submit the executive summary report of the study within 30 days while a copy of the clinical study report in ICH E3 format should be submitted to us within 180 days of the study closure</li> </ol> <div> Yours Sincerely, </div> :signature :approver For Chief Executive Officer 
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 approvermanager
 approval_date07-01-2025
 expiry_date07-01-2026
 statusapproved
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 created2025-01-07 09:16:01
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 AmendmentLetter(array)
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 content<h3 style="text-align: center;"> <img height="86" src="https://lh7-us.googleusercontent.com/eOWVvo3AHW74GguHveDaqdgy3YwNZqOqOO0QtscRoV4hJfcvt8Q6v4oLN3beVNvClvoD1ncu1RhB5D4iuAY-5R9h1aD2lEGqUorBVcQ0azfxsdvIz-WhbF3rA9-VQomtusnP2bNZTuYLFTC6vQ46nQ" style="background-color: transparent; color: rgb(0, 0, 0); font-family: "Bookman Old Style", serif; font-size: 11pt; white-space-collapse: preserve; margin-left: 0px; margin-top: 0px;" width="116" /></h3> MINISTRY OF HEALTH PHARMACY AND POISONS BOARD <table style="width: 100%; border:0px"> <tbody> <tr> <td style="width: 33.33%; border:0px"> <div id="left-editor"> Telegram: "MINHEALTH", Nairobi Cell phone: 0709 770 100 Email: info@pharmacyboardkenya.org Website: web.pharmacyboardkenya.org </div> </td> <td style="width: 33.33%;border:0px"> </td> <td style="width: 33.33%;border:0px"> <div id="right-editor"> Pharmacy and Poisons Board House Along Lenana Road P.O. Box 27663-00506 NAIROBI 25th March 2025 </div> </td> </tr> </tbody> </table> Dear Sir/Madam, Re: ECCT/24/12/01 : Amendment Approval; sample . Reference is made to the above study. We acknowledge receipt of the following documents; <div style="margin-left: 15px;"> </div> After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials grants amendment approval to the study sample . (ECCT/24/12/01). Yours Sincerely, :signature :approver For Chief Executive Officer 
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 approvermanager
 approval_date2025-03-25
 expiry_date2025-12-17
 statusamd-3
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 modified2025-03-25 13:03:45
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 approval_noPPB/ECCT/24/12/01/2024(7)
 content<h3 style="text-align: center;"> <img height="86" src="https://lh7-us.googleusercontent.com/eOWVvo3AHW74GguHveDaqdgy3YwNZqOqOO0QtscRoV4hJfcvt8Q6v4oLN3beVNvClvoD1ncu1RhB5D4iuAY-5R9h1aD2lEGqUorBVcQ0azfxsdvIz-WhbF3rA9-VQomtusnP2bNZTuYLFTC6vQ46nQ" style="background-color: transparent; color: rgb(0, 0, 0); font-family: "Bookman Old Style", serif; font-size: 11pt; white-space-collapse: preserve; margin-left: 0px; margin-top: 0px;" width="116" /></h3> MINISTRY OF HEALTH PHARMACY AND POISONS BOARD <table style="width: 100%; border:0px"> <tbody> <tr> <td style="width: 33.33%; border:0px"> <div id="left-editor"> Telegram: "MINHEALTH", Nairobi Cell phone: 0709 770 100 Email: info@pharmacyboardkenya.org Website: web.pharmacyboardkenya.org </div> </td> <td style="width: 33.33%;border:0px"> </td> <td style="width: 33.33%;border:0px"> <div id="right-editor"> Pharmacy and Poisons Board House Along Lenana Road P.O. Box 27663-00506 NAIROBI 25th March 2025 </div> </td> </tr> </tbody> </table> Dear Sir/Madam, Re: ECCT/24/12/01 : Amendment Approval; sample . Reference is made to the above study. We acknowledge receipt of the following documents; <div style="margin-left: 15px;"> </div> After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials grants amendment approval to the study sample . (ECCT/24/12/01). Yours Sincerely, :signature :approver For Chief Executive Officer 
 qrcode(null)
 approvermanager
 approval_date2025-03-25
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 statusamd-3
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 approval_noPPB/ECCT/24/12/01/2024(8)
 content<h3 style="text-align: center;"> <img height="86" src="https://lh7-us.googleusercontent.com/eOWVvo3AHW74GguHveDaqdgy3YwNZqOqOO0QtscRoV4hJfcvt8Q6v4oLN3beVNvClvoD1ncu1RhB5D4iuAY-5R9h1aD2lEGqUorBVcQ0azfxsdvIz-WhbF3rA9-VQomtusnP2bNZTuYLFTC6vQ46nQ" style="background-color: transparent; color: rgb(0, 0, 0); font-family: "Bookman Old Style", serif; font-size: 11pt; white-space-collapse: preserve; margin-left: 0px; margin-top: 0px;" width="116" /></h3> MINISTRY OF HEALTH PHARMACY AND POISONS BOARD <table style="width: 100%; border:0px"> <tbody> <tr> <td style="width: 33.33%; border:0px"> <div id="left-editor"> Telegram: "MINHEALTH", Nairobi Cell phone: 0709 770 100 Email: info@pharmacyboardkenya.org Website: web.pharmacyboardkenya.org </div> </td> <td style="width: 33.33%;border:0px"> </td> <td style="width: 33.33%;border:0px"> <div id="right-editor"> Pharmacy and Poisons Board House Along Lenana Road P.O. Box 27663-00506 NAIROBI 25th March 2025 </div> </td> </tr> </tbody> </table> Dear Sir/Madam, Re: ECCT/24/12/01 : Amendment Approval; sample . Reference is made to the above study. We acknowledge receipt of the following documents; <div style="margin-left: 15px;"> </div> After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials grants amendment approval to the study sample . (ECCT/24/12/01). Yours Sincerely, :signature :approver For Chief Executive Officer 
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 approvermanager
 approval_date2025-03-25
 expiry_date2025-12-17
 statusamd-3
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 deleted_date(null)
 created2025-03-25 13:36:59
 modified2025-03-25 13:36:59
 3(array)
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 content<h3 style="text-align: center;"> <img height="86" src="https://lh7-us.googleusercontent.com/eOWVvo3AHW74GguHveDaqdgy3YwNZqOqOO0QtscRoV4hJfcvt8Q6v4oLN3beVNvClvoD1ncu1RhB5D4iuAY-5R9h1aD2lEGqUorBVcQ0azfxsdvIz-WhbF3rA9-VQomtusnP2bNZTuYLFTC6vQ46nQ" style="background-color: transparent; color: rgb(0, 0, 0); font-family: "Bookman Old Style", serif; font-size: 11pt; white-space-collapse: preserve; margin-left: 0px; margin-top: 0px;" width="116" /></h3> MINISTRY OF HEALTH PHARMACY AND POISONS BOARD <table style="width: 100%; border:0px"> <tbody> <tr> <td style="width: 33.33%; border:0px"> <div id="left-editor"> Telegram: "MINHEALTH", Nairobi Cell phone: 0709 770 100 Email: info@pharmacyboardkenya.org Website: web.pharmacyboardkenya.org </div> </td> <td style="width: 33.33%;border:0px"> </td> <td style="width: 33.33%;border:0px"> <div id="right-editor"> Pharmacy and Poisons Board House Along Lenana Road P.O. Box 27663-00506 NAIROBI 25th March 2025 </div> </td> </tr> </tbody> </table> Dear Sir/Madam, Re: ECCT/24/12/01 : Amendment Approval; sample . Reference is made to the above study. We acknowledge receipt of the following documents; <div style="margin-left: 15px;"> 1. Cover letter <a href="http://45.79.161.190:8080/attachments/download/1794">known_hosts</a> dated Version <a href="http://45.79.161.190:8080/attachments/download/1795">id_rsa_2.pub</a> dated Version </div> After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials grants amendment approval to the study sample . (ECCT/24/12/01). Yours Sincerely, :signature :approver For Chief Executive Officer 
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 foreign_key125
 dirnameimg
 basenamelogo_47.png
 checksumc0a119cbad26d41a09d41f4c87635f4e
 alternative(null)
 groupapplicant_protocol
 descriptionThe Study Protocol *
 year(null)
 file_date02-12-2024
 pocket_nameapplicant_protocol
 version_no3
 created2024-12-17 08:33:51
 modified2024-12-17 08:33:51
 pathimg/logo_47.png
 3(array)
 id1120
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/img/logo_48.png
 foreign_key125
 dirnameimg
 basenamelogo_48.png
 checksumc0a119cbad26d41a09d41f4c87635f4e
 alternative(null)
 groupapplicant_pan_african
 descriptionRegistration of the study at Pan African Clinical Trials Registry https://pactr.samrc.ac.za *
 year(null)
 file_date10-12-2024
 pocket_nameapplicant_pan_african
 version_no4
 created2024-12-17 08:34:08
 modified2024-12-17 08:34:08
 pathimg/logo_48.png
 4(array)
 id1121
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/img/logo_49.png
 foreign_key125
 dirnameimg
 basenamelogo_49.png
 checksumc0a119cbad26d41a09d41f4c87635f4e
 alternative(null)
 groupapplicant_patient_information
 descriptionPatient Information leaflet and Informed consent form *
 year(null)
 file_date01-12-2024
 pocket_nameapplicant_patient_information
 version_no4
 created2024-12-17 08:34:18
 modified2024-12-17 08:34:18
 pathimg/logo_49.png
 5(array)
 id1122
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/img/logo_50.png
 foreign_key125
 dirnameimg
 basenamelogo_50.png
 checksumc0a119cbad26d41a09d41f4c87635f4e
 alternative(null)
 groupapplicant_investigators_brochure
 descriptionInvestigators Brochure/Package inserts *
 year(null)
 file_date03-12-2024
 pocket_nameapplicant_investigators_brochure
 version_no3
 created2024-12-17 08:35:42
 modified2024-12-17 08:35:42
 pathimg/logo_50.png
 6(array)
 id1123
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/img/logo_51.png
 foreign_key125
 dirnameimg
 basenamelogo_51.png
 checksumc0a119cbad26d41a09d41f4c87635f4e
 alternative(null)
 groupapplicant_impd
 descriptionInvestigational Medicinal Product Dossier (IMPD) *
 year(null)
 file_date02-12-2024
 pocket_nameapplicant_impd
 version_no3
 created2024-12-17 08:35:53
 modified2024-12-17 08:35:53
 pathimg/logo_51.png
 7(array)
 id1124
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/img/logo_52.png
 foreign_key125
 dirnameimg
 basenamelogo_52.png
 checksumc0a119cbad26d41a09d41f4c87635f4e
 alternative(null)
 groupapplicant_prev_data
 descriptionAdequate data and information from previous studies and Phases to support carrying out of the current study *
 year(null)
 file_date02-12-2024
 pocket_nameapplicant_prev_data
 version_no3
 created2024-12-17 08:36:11
 modified2024-12-17 08:36:11
 pathimg/logo_52.png
 8(array)
 id1125
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/img/logo_53.png
 foreign_key125
 dirnameimg
 basenamelogo_53.png
 checksumc0a119cbad26d41a09d41f4c87635f4e
 alternative(null)
 groupapplicant_stability_data
 descriptionStability data of the investigational product *
 year(null)
 file_date03-12-2024
 pocket_nameapplicant_stability_data
 version_no3
 created2024-12-17 08:36:24
 modified2024-12-17 08:36:24
 pathimg/logo_53.png
 9(array)
 id1126
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/img/logo_54.png
 foreign_key125
 dirnameimg
 basenamelogo_54.png
 checksumc0a119cbad26d41a09d41f4c87635f4e
 alternative(null)
 groupapplicant_analysis_cert
 descriptionCertificate of Analysis of the investigational product *
 year(null)
 file_date02-12-2024
 pocket_nameapplicant_analysis_cert
 version_no4
 created2024-12-17 08:36:37
 modified2024-12-17 08:36:37
 pathimg/logo_54.png
 10(array)
 id1127
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/img/logo_55.png
 foreign_key125
 dirnameimg
 basenamelogo_55.png
 checksumc0a119cbad26d41a09d41f4c87635f4e
 alternative(null)
 groupapplicant_pictorial_sample
 descriptionPictorial Sample of the investigational products. This sample should include the text of the labeling to be used *
 year(null)
 file_date03-12-2024
 pocket_nameapplicant_pictorial_sample
 version_no4
 created2024-12-17 08:47:43
 modified2024-12-17 08:47:43
 pathimg/logo_55.png
 11(array)
 id1128
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/img/logo_56.png
 foreign_key125
 dirnameimg
 basenamelogo_56.png
 checksumc0a119cbad26d41a09d41f4c87635f4e
 alternative(null)
 groupapplicant_investigators_cv
 descriptionSigned investigator(s) CV(s) including that of study Pharmacist (NB: The CV should include the current workload of the Principal Investigator ) *
 year(null)
 file_date03-12-2024
 pocket_nameapplicant_investigators_cv
 version_no4
 created2024-12-17 08:47:51
 modified2024-12-17 08:47:51
 pathimg/logo_56.png
 12(array)
 id1129
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/img/logo_57.png
 foreign_key125
 dirnameimg
 basenamelogo_57.png
 checksumc0a119cbad26d41a09d41f4c87635f4e
 alternative(null)
 groupapplicant_contractual_agreement
 descriptionEvidence of contractual agreement between sponsor and Principal Investigator. *
 year(null)
 file_date02-12-2024
 pocket_nameapplicant_contractual_agreement
 version_no4
 created2024-12-17 08:48:04
 modified2024-12-17 08:48:04
 pathimg/logo_57.png
 13(array)
 id1130
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/img/logo_58.png
 foreign_key125
 dirnameimg
 basenamelogo_58.png
 checksumc0a119cbad26d41a09d41f4c87635f4e
 alternative(null)
 groupapplicant_dsmb_charter
 descriptionDSMB Charter including the composition and meeting schedule *
 year(null)
 file_date02-12-2024
 pocket_nameapplicant_dsmb_charter
 version_no2
 created2024-12-17 08:49:56
 modified2024-12-17 08:49:56
 pathimg/logo_58.png
 14(array)
 id1131
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/img/logo_59.png
 foreign_key125
 dirnameimg
 basenamelogo_59.png
 checksumc0a119cbad26d41a09d41f4c87635f4e
 alternative(null)
 groupapplicant_gcp_training
 descriptionEvidence of recent GCP training of the core study staff *
 year(null)
 file_date04-12-2024
 pocket_nameapplicant_gcp_training
 version_no6
 created2024-12-17 08:49:56
 modified2024-12-17 08:49:56
 pathimg/logo_59.png
 15(array)
 id1132
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/img/logo_60.png
 foreign_key125
 dirnameimg
 basenamelogo_60.png
 checksumc0a119cbad26d41a09d41f4c87635f4e
 alternative(null)
 groupapplicant_detailed_budget
 descriptionDetailed budget of the study *
 year(null)
 file_date03-12-2024
 pocket_nameapplicant_detailed_budget
 version_no4
 created2024-12-17 08:50:11
 modified2024-12-17 08:50:11
 pathimg/logo_60.png
 16(array)
 id1133
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/img/logo_61.png
 foreign_key125
 dirnameimg
 basenamelogo_61.png
 checksumc0a119cbad26d41a09d41f4c87635f4e
 alternative(null)
 groupapplicant_financial_declaration
 descriptionFinancial declaration by Sponsor and/or PI *
 year(null)
 file_date10-12-2024
 pocket_nameapplicant_financial_declaration
 version_no5
 created2024-12-17 08:50:43
 modified2024-12-17 08:50:43
 pathimg/logo_61.png
 17(array)
 id1134
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/img/logo_62.png
 foreign_key125
 dirnameimg
 basenamelogo_62.png
 checksumc0a119cbad26d41a09d41f4c87635f4e
 alternative(null)
 groupapplicant_signed_declaration
 descriptionSigned Declaration by Sponsor or Principal investigator that the study will be carried out according to the protocol and applicable laws, regulations and GCP requirements. *
 year(null)
 file_date03-12-2024
 pocket_nameapplicant_signed_declaration
 version_no3
 created2024-12-17 08:50:52
 modified2024-12-17 08:50:52
 pathimg/logo_62.png
 18(array)
 id1135
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/img/logo_63.png
 foreign_key125
 dirnameimg
 basenamelogo_63.png
 checksumc0a119cbad26d41a09d41f4c87635f4e
 alternative(null)
 groupapplicant_indemnity_pi
 descriptionIndemnity cover for PI, investigators and study Pharmacist. *
 year(null)
 file_date03-12-2024
 pocket_nameapplicant_indemnity_pi
 version_no5
 created2024-12-17 08:51:05
 modified2024-12-17 08:51:05
 pathimg/logo_63.png
 19(array)
 id1136
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/img/logo_64.png
 foreign_key125
 dirnameimg
 basenamelogo_64.png
 checksumc0a119cbad26d41a09d41f4c87635f4e
 alternative(null)
 groupapplicant_indemnity_cover
 descriptionClinical Trials Insurance cover for study participants *
 year(null)
 file_date03-12-2024
 pocket_nameapplicant_indemnity_cover
 version_no2
 created2024-12-17 08:51:15
 modified2024-12-17 08:51:15
 pathimg/logo_64.png
 20(array)
 id1137
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/img/logo_65.png
 foreign_key125
 dirnameimg
 basenamelogo_65.png
 checksumc0a119cbad26d41a09d41f4c87635f4e
 alternative(null)
 groupapplicant_practice_license
 descriptionCopy of current Practice Licenses for the Investigators and study Pharmacist *
 year(null)
 file_date02-12-2024
 pocket_nameapplicant_practice_license
 version_no2
 created2024-12-17 08:52:14
 modified2024-12-17 08:52:14
 pathimg/logo_65.png
 21(array)
 id1138
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/img/logo_66.png
 foreign_key125
 dirnameimg
 basenamelogo_66.png
 checksumc0a119cbad26d41a09d41f4c87635f4e
 alternative(null)
 groupapplicant_opinion_letter
 descriptionCopy of favorable opinion letter from the local Ethics Review Committee (ERC). *
 year(null)
 file_date03-12-2024
 pocket_nameapplicant_opinion_letter
 version_no1
 created2024-12-17 08:52:16
 modified2024-12-17 08:52:16
 pathimg/logo_66.png
 22(array)
 id1139
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/img/logo_67.png
 foreign_key125
 dirnameimg
 basenamelogo_67.png
 checksumc0a119cbad26d41a09d41f4c87635f4e
 alternative(null)
 groupapplicant_approval_letter
 descriptionCopy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable
 year(null)
 file_date02-12-2024
 pocket_nameapplicant_approval_letter
 version_no1
 created2024-12-17 08:52:26
 modified2024-12-17 08:52:26
 pathimg/logo_67.png
 23(array)
 id1140
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/img/logo_68.png
 foreign_key125
 dirnameimg
 basenamelogo_68.png
 checksumc0a119cbad26d41a09d41f4c87635f4e
 alternative(null)
 groupapplicant_addendum
 descriptionFor multicentre/multi-site studies, a site specific addendum for each of the proposed sites including among other things the sites’ capacity to carry out the study i.e personnel, equipment, laboratory etc
 year(null)
 file_date12-12-2024
 pocket_nameapplicant_addendum
 version_no5
 created2024-12-17 08:52:41
 modified2024-12-17 08:52:41
 pathimg/logo_68.png
 24(array)
 id1141
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/img/logo_69.png
 foreign_key125
 dirnameimg
 basenamelogo_69.png
 checksumc0a119cbad26d41a09d41f4c87635f4e
 alternative(null)
 groupstatistical_analysis_plan
 descriptionStatistical Analysis Plan *
 year(null)
 file_date02-12-2024
 pocket_namestatistical_analysis_plan
 version_no1
 created2024-12-17 08:52:56
 modified2024-12-17 08:52:56
 pathimg/logo_69.png
 25(array)
 id1142
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/img/logo_70.png
 foreign_key125
 dirnameimg
 basenamelogo_70.png
 checksumc0a119cbad26d41a09d41f4c87635f4e
 alternative(null)
 groupapplicant_signed_checklist
 descriptionSigned Checklist *
 year(null)
 file_date02-12-2024
 pocket_nameapplicant_signed_checklist
 version_no2
 created2024-12-17 08:52:56
 modified2024-12-17 08:53:19
 pathimg/logo_70.png
 26(array)
 id1143
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/img/logo_71.png
 foreign_key125
 dirnameimg
 basenamelogo_71.png
 checksumc0a119cbad26d41a09d41f4c87635f4e
 alternative(null)
 groupapplicant_fees
 descriptionPayment of fees *
 year(null)
 file_date02-12-2024
 pocket_nameapplicant_fees
 version_no9
 created2024-12-17 08:53:04
 modified2024-12-17 08:53:04
 pathimg/logo_71.png
 27(array)
 id1144
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/img/logo_72.png
 foreign_key125
 dirnameimg
 basenamelogo_72.png
 checksumc0a119cbad26d41a09d41f4c87635f4e
 alternative(null)
 groupapplicant_statement
 descriptionA signed statement by the applicant indicating that all information contained in, or referenced by, the application is complete and accurate and is not false or misleading. *
 year(null)
 file_date13-12-2024
 pocket_nameapplicant_statement
 version_no2
 created2024-12-17 08:53:12
 modified2024-12-17 08:53:12
 pathimg/logo_72.png
 StudyMonitor(empty)
 ProtocolOutsource(empty)
 Outsource(empty)
- redir
- $request->data(empty)
- $this->validationErrors(array)
 Permission(empty)
 Aro(empty)
 Aco(empty)
 Application(empty)
 User(empty)
 TrialStatus(empty)
 Review(empty)
 ActiveInspector(empty)
 ManagerReview(empty)
 Acceptance(empty)
 Amendment(empty)
 InvestigatorContact(empty)
 ApplicationStage(empty)
 Pharmacist(empty)
 EthicalCommittee(empty)
 AnnualLetter(empty)
 AmendmentLetter(empty)
 AmendmentApproval(empty)
 AmendmentApprovalSummary(empty)
 Organization(empty)
 SiteDetail(empty)
 Placebo(empty)
 Sponsor(empty)
 SiteInspection(empty)
 Sae(empty)
 Ciom(empty)
 StudyRoute(empty)
 Manufacturer(empty)
 Reassignment(empty)
 Attachment(empty)
 AnnualApproval(empty)
 AmendmentChecklist(empty)
 Reminder(empty)
 ParticipantFlow(empty)
 Budget(empty)
 Deviation(empty)
 Document(empty)
 CoverLetter(empty)
 Protocol(empty)
 PatientLeaflet(empty)
 Brochure(empty)
 GmpCertificate(empty)
 Cv(empty)
 Finance(empty)
 Declaration(empty)
 IndemnityCover(empty)
 OpinionLetter(empty)
 ApprovalLetter(empty)
 Statement(empty)
 ParticipatingStudy(empty)
 Addendum(empty)
 Registration(empty)
 Fee(empty)
 Checklist(empty)
 StudyMonitor(empty)
 ProtocolOutsource(empty)
 Outsource(empty)
- Loaded Helpers(array)
 0Html
 1Form
 2Session
 3Text
 4Number
 5SimpleGraph
 6DebugTimer
 7Toolbar
 8HtmlToolbar
====

Environment

App Constants

Constant	Value
MEDIA	'/var/www/ctr/app/webroot/media/'
MEDIA_STATIC	'/var/www/ctr/app/webroot/media/static/'
MEDIA_FILTER	'/var/www/ctr/app/webroot/media/filter/'
MEDIA_TRANSFER	'/var/www/ctr/app/webroot/media/transfer/'
MEDIA_URL	'media/'
MEDIA_STATIC_URL	'media/static/'
MEDIA_FILTER_URL	'media/filter/'
MEDIA_TRANSFER_URL	'media/transfer/'
HTTP_HOST	'45.79.161.190:8080'
HTTP_BASE	'http://45.79.161.190:8080'
HTTP_SELF	'/app/webroot/index.php'
HTTP_URI	'/applications/view/125'
CHOWN_PUBLIC	(int) 504
LF	''
NL	''
CR	''
TB	''
BR	' '
WINDOWS	false
FORMAT_DB_DATETIME	'Y-m-d H:i:s'
FORMAT_DB_DATE	'Y-m-d'
FORMAT_DB_TIME	'H:i:s'
DEFAULT_DATETIME	'0000-00-00 00:00:00'
DEFAULT_DATE	'0000-00-00'
DEFAULT_TIME	'00:00:00'
FILES	'/var/www/ctr/app/files/'
LOCALE	'/var/www/ctr/app/locale/'
CLASS_USER	'User'
VALID_ALPHA	'/^[a-zA-Z]+$/'
VALID_ALPHA_UNDERSCORES	'/^[a-zA-Z_]+$/'
VALID_ALPHA_MINUS_UNDERSCORES	'/^[a-zA-Z_-]+$/'
VALID_ALPHA_WHITESPACES	'/^[a-zA-Z ]+$/'
VALID_ALPHANUMERIC_UNDERSCORES	'/^[\da-zA-Z_]+$/'
VALID_ALPHANUMERIC_MINUS_UNDERSCORES	'/^[\da-zA-Z_-]+$/'
VALID_ALPHANUMERIC_WHITESPACES	'/^[\da-zA-Z ]+$/'
VALID_ALPHANUMERIC_WHITESPACES_UNDERSCORES	'/^[\da-zA-Z _]+$/'
VALID_NUMERIC_UNDERSCORES	'/^[\d_]+$/'
VALID_NUMERIC_WHITESPACES	'/^[\d ]+$/'
VALID_NUMERIC_WHITESPACES_UNDERSCORES	'/^[\d _]+$/'
VALID_INTEGERS	'/^[\d]+$/'
FORMAT_NICE_YMDHMS	'd.m.Y, H:i:s'
FORMAT_NICE_YMDHM	'd.m.Y, H:i'
FORMAT_NICE_YM	'm.Y'
FORMAT_NICE_YMD	'd.m.Y'
FORMAT_NICE_MD	'd.m.'
FORMAT_NICE_D	'd'
FORMAT_NICE_W_NUM	'w'
FORMAT_NICE_W_ABBR	'D'
FORMAT_NICE_W_FULL	'l'
FORMAT_NICE_M	'm'
FORMAT_NICE_M_ABBR	'M'
FORMAT_NICE_M_FULL	'F'
FORMAT_NICE_Y_ABBR	'y'
FORMAT_NICE_Y	'Y'
FORMAT_NICE_HM	'H:i'
FORMAT_NICE_HMS	'H:i:s'
FORMAT_LOCAL_WA_YMDHMS	'%a, %d.%m.%Y, %H:%M:%S'
FORMAT_LOCAL_WF_YMDHMS	'%A, %d.%m.%Y, %H:%M:%S'
FORMAT_LOCAL_WA_YMDHM	'%a, %d.%m.%Y, %H:%M'
FORMAT_LOCAL_WF_YMDHM	'%A, %d.%m.%Y, %H:%M'
FORMAT_LOCAL_YMDHMS	'%d.%m.%Y, %H:%M:%S'
FORMAT_LOCAL_YMDHM	'%d.%m.%Y, %H:%M'
FORMAT_LOCAL_YMD	'%d.%m.%Y'
FORMAT_LOCAL_MD	'%d.%m.'
FORMAT_LOCAL_D	'%d'
FORMAT_LOCAL_W_NUM	'%w'
FORMAT_LOCAL_W_ABBR	'%a'
FORMAT_LOCAL_W_FULL	'%A'
FORMAT_LOCAL_M	'%m'
FORMAT_LOCAL_M_ABBR	'%b'
FORMAT_LOCAL_M_FULL	'%B'
FORMAT_LOCAL_Y_ABBR	'%y'
FORMAT_LOCAL_YMS_ABBR	'%d.%m.%y'
FORMAT_LOCAL_Y	'%Y'
FORMAT_LOCAL_H	'%H'
FORMAT_LOCAL_S	'%S'
FORMAT_LOCAL_HM	'%H:%M'
FORMAT_LOCAL_HMS	'%H:%M:%S'
CHAR_LESS	'<'
CHAR_GREATER	'>'
CHAR_QUOTE	'"'
CHAR_APOSTROPHE	'''
CHAR_ARROWS	'»'
CHAR_ARROWS_R	'»'
CHAR_ARROWS_L	'«'
CHAR_AVERAGE	'Ø'
CHAR_INFIN	'∞'
CHAR_MILL	'‰'
CHAR_PLUSMN	'±'
CHAR_HELLIP	'…'
CHAR_CIRCA	'≈'
CHAR_CHECKBOX_EMPTY	'☐]'
CHAR_CHECKBOX_MAKRED	'☑'
CHAR_CHECKMARK	'✓'
CHAR_CHECKMARK_BOLD	'✔'
CHAR_BALLOT	'✗'
CHAR_BALLOT_BOLD	'✘'
CHAR_ABOUT	'≈'
CHAR_RPIME	'′'
CHAR_DOUBLE_RPIME	'″'

CakePHP Constants

Constant	Value
APP	'/var/www/ctr/app/'
APP_DIR	'app'
APPLIBS	'/var/www/ctr/app/Lib/'
CACHE	'/var/www/ctr/app/tmp/cache/'
CAKE	'/var/www/ctr/lib/Cake/'
CAKE_CORE_INCLUDE_PATH	'/var/www/ctr/lib'
CORE_PATH	'/var/www/ctr/lib/'
CAKE_VERSION	'2.2.2'
CSS	'/var/www/ctr/app/webroot/css/'
CSS_URL	'css/'
DS	'/'
FULL_BASE_URL	'http://45.79.161.190:8080'
IMAGES	'/var/www/ctr/app/webroot/img/'
IMAGES_URL	'img/'
JS	'/var/www/ctr/app/webroot/js/'
JS_URL	'js/'
LOGS	'/var/www/ctr/app/tmp/logs/'
ROOT	'/var/www/ctr'
TESTS	'/var/www/ctr/app/Test/'
TMP	'/var/www/ctr/app/tmp/'
VENDORS	'/var/www/ctr/vendors/'
WEBROOT_DIR	'webroot'
WWW_ROOT	'/var/www/ctr/app/webroot/'

PHP Environment

Environment Variable	Value
Php Version	'5.6.40-63+ubuntu18.04.1+deb.sury.org+2'
Redirect Redirect Status	'200'
Redirect Status	'200'
Http Accept	'/'
Http User Agent	'Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)'
Http Cookie	'CAKEPHP=fpa13du1sn97vlqtdeqln8io85'
Http Accept Encoding	'gzip, br, zstd, deflate'
Http Host	'45.79.161.190:8080'
Http Via	'1.1 squid-proxy-5b5d847c96-qq957 (squid/6.10)'
Http X Forwarded For	'10.3.82.253'
Http Cache Control	'max-age=259200'
Http Connection	'keep-alive'
Path	'/usr/local/sbin:/usr/local/bin:/usr/sbin:/usr/bin:/sbin:/bin:/snap/bin'
Server Signature	' Apache/2.4.29 (Ubuntu) Server at 45.79.161.190 Port 8080 '
Server Software	'Apache/2.4.29 (Ubuntu)'
Server Name	'45.79.161.190'
Server Addr	'45.79.161.190'
Server Port	'8080'
Remote Addr	'216.73.216.36'
Document Root	'/var/www/ctr'
Request Scheme	'http'
Context Prefix	''
Context Document Root	'/var/www/ctr'
Server Admin	'webmaster@localhost'
Script Filename	'/var/www/ctr/app/webroot/index.php'
Remote Port	'1137'
Redirect Url	'/app/webroot/applications/view/125'
Gateway Interface	'CGI/1.1'
Server Protocol	'HTTP/1.1'
Request Method	'GET'
Query String	''
Request Uri	'/applications/view/125'
Script Name	'/app/webroot/index.php'
Php Self	'/app/webroot/index.php'
Request Time Float	(float) 1756471562.156
Request Time	(int) 1756471562

====

Include
+
Included Files

Include Paths
- 0/var/www/ctr/app/Plugin/Media/Lib/mm/src
- 1/var/www/ctr/lib
- 3/usr/share/php
- 4-> /var/www/ctr/lib/Cake/
Included Files
- core(array)
  Behavior(array)
  0CORE/Model/Behavior/TreeBehavior.php
  1CORE/Model/Behavior/ContainableBehavior.php
  2CORE/Model/Behavior/AclBehavior.php
  Cache(array)
  0CORE/Cache/Cache.php
  1CORE/Cache/Engine/FileEngine.php
  2CORE/Cache/CacheEngine.php
  Component(array)
  0CORE/Controller/Component/AclComponent.php
  1CORE/Controller/Component/Acl/DbAcl.php
  2CORE/Controller/Component/Acl/AclInterface.php
  3CORE/Controller/Component/AuthComponent.php
  4CORE/Controller/Component/RequestHandlerComponent.php
  5CORE/Controller/Component/SessionComponent.php
  Config(array)
  0CORE/Config/routes.php
  1CORE/Config/config.php
  Controller(array)
  0CORE/Controller/Controller.php
  1CORE/Controller/ComponentCollection.php
  2CORE/Controller/Component.php
  Datasource(array)
  0CORE/Model/Datasource/CakeSession.php
  1CORE/Model/Datasource/Database/Mysql.php
  2CORE/Model/Datasource/DboSource.php
  3CORE/Model/Datasource/DataSource.php
  Error(array)
  0CORE/Error/exceptions.php
  1CORE/Error/ErrorHandler.php
  I18n(array)
  0CORE/I18n/I18n.php
  1CORE/I18n/L10n.php
  Log(array)
  0CORE/Log/CakeLog.php
  1CORE/Log/LogEngineCollection.php
  2CORE/Log/Engine/FileLog.php
  3CORE/Log/Engine/BaseLog.php
  4CORE/Log/CakeLogInterface.php
  Model(array)
  0CORE/Model/ConnectionManager.php
  1CORE/Model/Permission.php
  2CORE/Model/Model.php
  3CORE/Model/BehaviorCollection.php
  4CORE/Model/Aro.php
  5CORE/Model/AclNode.php
  6CORE/Model/Aco.php
  7CORE/Model/ModelBehavior.php
  Network(array)
  0CORE/Network/CakeRequest.php
  1CORE/Network/CakeResponse.php
  Other(array)
  0CORE/bootstrap.php
  1CORE/basics.php
  2CORE/Core/App.php
  3CORE/Core/Configure.php
  4CORE/Core/CakePlugin.php
  5CORE/Event/CakeEventListener.php
  6CORE/Event/CakeEvent.php
  7CORE/Event/CakeEventManager.php
  8CORE/Core/Object.php
  Routing(array)
  0CORE/Routing/Dispatcher.php
  1CORE/Routing/Filter/AssetDispatcher.php
  2CORE/Routing/DispatcherFilter.php
  3CORE/Routing/Filter/CacheDispatcher.php
  4CORE/Routing/Router.php
  5CORE/Routing/Route/CakeRoute.php
  6CORE/Routing/Route/PluginShortRoute.php
  Utility(array)
  0CORE/Utility/Hash.php
  1CORE/Utility/Inflector.php
  2CORE/Utility/ObjectCollection.php
  3CORE/Utility/Debugger.php
  4CORE/Utility/String.php
  5CORE/Utility/ClassRegistry.php
  6CORE/Utility/Set.php
  View(array)
  0CORE/View/HelperCollection.php
- app(array)
  Behavior(array)
  0APP/Model/Behavior/SoftDeleteBehavior.php
  1APP/Model/Behavior/TimestampBehavior.php
  Config(array)
  0APP/Config/core.php
  1APP/Config/bootstrap.php
  2APP/Config/routes.php
  3APP/Config/database.php
  Controller(array)
  0APP/Controller/ApplicationsController.php
  1APP/Controller/AppController.php
  Model(array)
  0APP/Model/AppModel.php
  1APP/Model/Application.php
  2APP/Model/User.php
  3APP/Model/TrialStatus.php
  4APP/Model/Review.php
  5APP/Model/ActiveInspector.php
  6APP/Model/Amendment.php
  7APP/Model/InvestigatorContact.php
  8APP/Model/ApplicationStage.php
  9APP/Model/Pharmacist.php
  10APP/Model/EthicalCommittee.php
  11APP/Model/AnnualLetter.php
  12APP/Model/AmendmentLetter.php
  13APP/Model/AmendmentApproval.php
  14APP/Model/Organization.php
  15APP/Model/SiteDetail.php
  16APP/Model/Placebo.php
  17APP/Model/Sponsor.php
  18APP/Model/SiteInspection.php
  19APP/Model/Sae.php
  20APP/Model/Ciom.php
  21APP/Model/StudyRoute.php
  22APP/Model/Manufacturer.php
  23APP/Model/Reassignment.php
  24APP/Model/Attachment.php
  25APP/Model/Reminder.php
  26APP/Model/ParticipantFlow.php
  27APP/Model/Budget.php
  28APP/Model/Deviation.php
  29APP/Model/StudyMonitor.php
  30APP/Model/ProtocolOutsource.php
  31APP/Model/Outsource.php
  Other(array)
  0APP/webroot/index.php
- plugins(array)
  CakePdf(array)
  Config(array)
  0CakePdf/Config/bootstrap.php
  1CakePdf/Config/routes.php
  CakeResque(array)
  Config(array)
  0CakeResque/Config/bootstrap.php
  Plugin(array)
  0CakeResque/Lib/CakeResque.php
  1CakeResque/vendor/kamisama/php-resque-ex/lib/Resque.php
  2CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Event.php
  3CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Exception.php
  DebugKit(array)
  Component(array)
  0DebugKit/Controller/Component/ToolbarComponent.php
  Plugin(array)
  0DebugKit/Lib/DebugMemory.php
  1DebugKit/Lib/Panel/HistoryPanel.php
  2DebugKit/Lib/DebugPanel.php
  3DebugKit/Lib/Panel/SessionPanel.php
  4DebugKit/Lib/Panel/RequestPanel.php
  5DebugKit/Lib/Panel/SqlLogPanel.php
  6DebugKit/Lib/Panel/TimerPanel.php
  7DebugKit/Lib/Panel/LogPanel.php
  8DebugKit/Lib/Log/Engine/DebugKitLog.php
  9DebugKit/Lib/Panel/VariablesPanel.php
  10DebugKit/Lib/Panel/EnvironmentPanel.php
  11DebugKit/Lib/Panel/IncludePanel.php
  12DebugKit/Lib/DebugTimer.php
  Media(array)
  Config(array)
  0Media/Config/bootstrap.php
  Plugin(array)
  0Media/Lib/mm/src/Mime/Type.php
  1Media/Lib/mm/src/Mime/Type/Magic/Adapter/Fileinfo.php
  2Media/Lib/mm/src/Mime/Type/Magic/Adapter.php
  3Media/Lib/mm/src/Mime/Type/Glob/Adapter/Memory.php
  4Media/Lib/mm/src/Mime/Type/Glob/Adapter.php
  5Media/Lib/mm/src/Media/Process.php
  6Media/Lib/mm/src/Media/Info.php
  Behavior(array)
  0Media/Model/Behavior/TransferBehavior.php
  1Media/Model/Behavior/CouplerBehavior.php
  2Media/Model/Behavior/MetaBehavior.php
  Search(array)
  Component(array)
  0Search/Controller/Component/PrgComponent.php
  Behavior(array)
  0Search/Model/Behavior/SearchableBehavior.php
  Shim(array)
  Config(array)
  0Shim/Config/bootstrap.php
  Tools(array)
  Config(array)
  0Tools/Config/bootstrap.php
====

Study Title:	sample
	Sample here
Study Objectives:	sample
Laymans Summary:	sample
2	test
Abstract of Study:	sample

Request History

Session

Request

Cake Params

Post data

Query string

Cookie

Current Route

Sql Logs

default

Total Time: 51 ms Total Queries: 53 queries

Query Explain:

Memory

Timers

Logs

View Variables

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

Included Files

Total Time: 51 ms
Total Queries: 53 queries