Pharmacy and Poisons Board: Applications

History
+
Request History
4 previous requests available
====
Session
+
Session
- Config(array)
  userAgent9c3d2c89526db53b7b69e8c9faa06145
  time1787004582
  countdown10
====
Request
+
Request

Cake Params
- plugin(null)
- controllerapplications
- actionview
- named(empty)
- pass(array)
  0196
- isAjax(false)
Post data

No post data.

Query string

No querystring data.

Cookie

To view Cookies, add CookieComponent to Controller

Current Route
- keys(array)
  0controller
  1action
- options(empty)
- defaults(array)
  plugin(null)
- template/:controller/:action/*
====

Sql Logs

default

Total Time: 81 ms
Total Queries: 54 queries

Query	Affected	Num. rows	Took (ms)	Actions
SELECT COUNT(*) AS `count` FROM `ctr`.`applications` AS `Application` WHERE `Application`.`id` = 196	1	1	1
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`.`protocol_not_ai_generated`, `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`, `Application`.`ai_content`, `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` = 196 AND `Application`.`deleted` = '0' LIMIT 1	1	1	3	maybe slow
SELECT `Review`.`id`, `Review`.`user_id`, `Review`.`application_id`, `Review`.`category`, `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`.`category` = '0' AND `Review`.`application_id` = (196)	0	0	1	maybe slow
SELECT `InternalReview`.`id`, `InternalReview`.`user_id`, `InternalReview`.`application_id`, `InternalReview`.`category`, `InternalReview`.`type`, `InternalReview`.`assessment_type`, `InternalReview`.`title`, `InternalReview`.`text`, `InternalReview`.`summary`, `InternalReview`.`recommendation`, `InternalReview`.`notified`, `InternalReview`.`accepted`, `InternalReview`.`conflict`, `InternalReview`.`status`, `InternalReview`.`created`, `InternalReview`.`modified` FROM `ctr`.`reviews` AS `InternalReview` WHERE `InternalReview`.`category` = '1' AND `InternalReview`.`application_id` = (196)	0	0	0
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` = (196)	0	0	1	maybe slow
SELECT `ManagerReview`.`id`, `ManagerReview`.`user_id`, `ManagerReview`.`application_id`, `ManagerReview`.`category`, `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` = (196)	0	0	0
SELECT `Acceptance`.`id`, `Acceptance`.`user_id`, `Acceptance`.`application_id`, `Acceptance`.`category`, `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` = (196)	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` = (196)	2	2	3	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`.`investigator_role`, `InvestigatorContact`.`created`, `InvestigatorContact`.`modified` FROM `ctr`.`investigator_contacts` AS `InvestigatorContact` WHERE `InvestigatorContact`.`application_id` = (196)	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` = (196)	7	7	1	maybe slow
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` = (196)	1	1	1
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` = (196)	1	1	1
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` = (196)	7	7	4	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` = (196)	0	0	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` = (196)	0	0	1	maybe slow
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` = (196)	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` = (196)	1	1	1
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` = (196)	1	1	2	maybe slow
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` = (196)	1	1	1
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` = (196)	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` = (196)	0	0	2	maybe slow
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` = (196)	1	1	1
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`, `Ciom`.`deleted` FROM `ctr`.`cioms` AS `Ciom` WHERE `Ciom`.`application_id` = (196)	0	0	2	maybe slow
SELECT `StudyRoute`.`id`, `StudyRoute`.`application_id`, `StudyRoute`.`study_route`, `StudyRoute`.`created`, `StudyRoute`.`modified` FROM `ctr`.`study_routes` AS `StudyRoute` WHERE `StudyRoute`.`application_id` = (196)	1	1	1
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` = (196)	1	1	1
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` = (196)	0	0	1	maybe slow
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` = (196)	0	0	4	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` = (196)	0	0	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` = (196)	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` = (196)	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` = (196)	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` = (196)	1	1	1
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_notification_date`, `Deviation`.`sponsor_explanation`, `Deviation`.`study_impact`, `Deviation`.`status`, `Deviation`.`date_submitted`, `Deviation`.`deleted`, `Deviation`.`deleted_date`, `Deviation`.`created`, `Deviation`.`modified` FROM `ctr`.`deviations` AS `Deviation` WHERE `Deviation`.`application_id` = (196)	0	0	1	maybe slow
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` = (196)	0	0	3	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` = (196)	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` = (196)	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` = (196)	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` = (196)	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` = (196)	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` = (196)	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` = (196)	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` = (196)	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` = (196)	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` = (196)	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` = (196)	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` = (196)	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` = (196)	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` = (196)	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` = (196)	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` = (196)	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` = (196)	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` = (196)	0	0	1	maybe slow
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` = (196)	0	0	1	maybe slow
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` = (196)	1	1	2	maybe slow

Query Explain:

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

====

Timer

Memory

Peak Memory Use 12.77 MB

Message	Memory use
Component initialization	2.44 MB
Controller action start	3.63 MB
Controller render start	8.37 MB
View render complete	8.81 MB

Timers

Total Request Time: 360 (ms)

Message	Time in ms	Graph
Core Processing (Derived from $_SERVER["REQUEST_TIME"])	11.00
Event: Controller.initialize	0.28
Event: Controller.startup	0.46
Controller action	290.30
Event: Controller.beforeRender	12.82
» Processing toolbar data	12.66
Rendering View	4.39
» Event: View.beforeRender	0.03
» Rendering APP/View/Applications/view.ctp	0.55
» Event: View.afterRender	0.02
» Event: View.beforeLayout	0.02
» Rendering APP/View/Layouts/default.ctp	3.42
» » Rendering APP/View/Elements/google-analytics.ctp	0.05
Event: View.afterLayout	0.00

====

Log
+

Logs

There were no log entries made this request

====
Variables
+
View Variables
- application(array)
 Application(array)
 id196
 user_id91
 application_id(null)
 is_child0
 trial_status_id8
 total_sites1
 abstract_of_study Test 2
 study_title Test Input
 laymans_summary<h1 style="color: blue;"> Test Input</h1>
 short_titleVoluptatem Doloremque in amet
 protocol_noECCT/25/02/06
 reference_noDeserunt assumenda dolor dolor quas eos distinctio Laborum Sint
 version_noFugiat sed omnis voluptates minima et iure et earum vol
 date_of_protocol20-10-2008
 study_drugEum earum velit adipisci eaque dolor enim sit aliqua Est rem non sint odio
 disease_conditionDolore quia cupidatat iusto laborum eu cupidatat magna doloremque repellendus Nobis odit quia dignissimos totam tenetur officiis eveniet illo ad
 product_type_biologicals0
 product_type_proteins1
 product_type_immunologicals1
 product_type_vaccines1
 product_type_hormones0
 product_type_toxoid1
 product_type_chemical1
 product_type_medical_device1
 product_type_chemical_nameBritanney Delgado
 product_type_medical_device_nameZelda Boyer
 comparatorNo
 comparator_nameNehru Cain
 comparator_registeredA est iure ab laborum ducimus
 comparator_countriesUt quasi facilis exc
 ecct_not_applicable0
 ecct_ref_number
 email_addressbmuyundo@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_applicantPerspiciatis sit eligendi voluptate dignissimos ad ab quo nulla et
 declaration_date119-05-1976
 declaration_principal_investigatorEt maiores totam adipisicing quasi nostrud nisi exercitation amet tempor qui aliquip neque et expedita ad dolore
 declaration_date219-02-2025
 protocol_not_ai_generated0
 placebo_presentYes
 study_objectives test
 principal_inclusion_criteria test
 principal_exclusion_criteria test
 primary_end_points test
 scope_diagnosis0
 scope_prophylaxis0
 scope_therapy1
 scope_safety1
 scope_efficacy0
 scope_pharmacokinetic1
 scope_pharmacodynamic0
 scope_bioequivalence1
 scope_dose_response1
 scope_pharmacogenetic0
 scope_pharmacogenomic1
 scope_pharmacoecomomic0
 scope_others0
 scope_others_specify
 trial_human_pharmacology1
 trial_administration_humans0
 trial_bioequivalence_study0
 trial_other0
 trial_other_specify
 trial_therapeutic_exploratory0
 trial_therapeutic_confirmatory1
 trial_therapeutic_use1
 design_controlledYes
 site_capacity(null)
 staff_numbers 200
 other_details_explanation test
 other_details_regulatory_notapproved test
 other_details_regulatory_approved test
 other_details_regulatory_rejected test
 other_details_regulatory_halted test
 estimated_durationDoloribus laboriosam placeat iste quis nostrud nobis
 design_controlled_randomisedNo
 design_controlled_openNo
 design_controlled_single_blindNo
 design_controlled_double_blindYes
 design_controlled_parallel_groupYes
 design_controlled_cross_overNo
 design_controlled_otherNo
 design_controlled_specify
 design_controlled_comparatorCulpa qui proident laud
 design_controlled_other_medicinalYes
 design_controlled_placeboYes
 design_controlled_medicinal_otherYes
 design_controlled_medicinal_specifySunt dolores eos elit aliquid illo id sequi perspiciatis voluptas est
 single_site_member_stateNo
 location_of_area
 single_site_physical_address
 single_site_contact_person
 single_site_telephone
 multiple_sites_member_stateYes
 multiple_countriesYes
 multiple_member_states906
 number_of_sites5
 multi_country_listVoluptas et magnam v
 data_monitoring_committeeYes
 total_enrolment_per_site10
 total_participants_worldwide10000
 population_less_than_18_yearsYes
 population_uteroYes
 population_preterm_newbornNo
 population_newbornYes
 population_infant_and_toddlerNo
 population_childrenNo
 population_adolescentNo
 population_above_18Yes
 population_adultNo
 population_elderlyNo
 gender_female0
 gender_male1
 subjects_healthyNo
 subjects_patientsYes
 subjects_vulnerable_populationsYes
 subjects_women_child_bearingNo
 subjects_women_using_contraceptionYes
 subjects_pregnant_womenNo
 subjects_nursing_womenNo
 subjects_emergency_situationNo
 subjects_incapable_consentNo
 subjects_specify
 subjects_othersNo
 subjects_others_specify
 investigator1_given_nameLev Rosa
 investigator1_middle_nameThomas Franks
 investigator1_family_nameZeus Cooley
 investigator1_qualificationExplicabo Quis quod cum ut voluptatibus officia nostrum dicta officia quaerat
 investigator1_professional_addressNam incididunt reprehenderit mollitia irure provident omnis laborum Eveniet eveniet Nam qui est consequatur excepteur quam labore asperiores ea animi
 investigator1_telephone+14099923636
 investigator1_emailfymoq@mailinator.com
 organisations_transferred_No
 number_participants200
 notification
 approval_date28-03-2025
 submitted1
 deleted0
 deleted_date(null)
 deactivated0
 date_submitted19-02-2025
 unsubmitted0
 initial_date_submitted(null)
 admin_stopped0
 admin_stopped_reasonsample
 approved1
 approved_reasonRejected Test Sample
 approved_date(null)
 final_report(null)
 implication_results(null)
 quantity_imported(null)
 quantity_dispensed(null)
 quantity_destroyed(null)
 quantity_exported(null)
 balance_site(null)
 final_date(null)
 ecitizen_invoice356991
 modified2025-03-28 11:42:43
 created2025-02-19 08:50:34
 ai_content(null)
 User(array)
 id91
 usernamebrian
 passwordee68d9627812445cb0ccfd02e319d77ad0f9f4c9
 confirm_passwordee68d9627812445cb0ccfd02e319d77ad0f9f4c9
 namebrian
 emailbmuyundo@intellisoftkenya.com
 national_id_number(null)
 sponsor(null)
 sponsor_emailsponsoremail@gmail.com
 qualification
 phone_no+254705985456
 name_of_institution
 institution_physical
 institution_address
 institution_contact
 county_id(null)
 country_id115
 group_id5
 activation_key(null)
 forgot_password(null)
 is_active1
 deactivated0
 created2025-02-13 12:42:56
 modified2025-02-19 08:49:16
 TrialStatus(array)
 id8
 valueWriting-up
 nameWriting-up
 created2013-10-07 18:21:37
 modified2013-10-07 18:21:37
 Review(empty)
 InternalReview(empty)
 ActiveInspector(empty)
 ManagerReview(empty)
 Acceptance(empty)
 Amendment(array)
 0(array)
 id51
 application_id196
 trial_status_id(null)
 abstract_of_study
 study_title
 laymans_summary
 protocol_no(null)
 version_no
 date_of_protocol(null)
 study_drug
 disease_condition
 product_type(null)
 product_type_biologicals(null)
 product_type_proteins(null)
 product_type_immunologicals(null)
 product_type_vaccines(null)
 product_type_hormones(null)
 product_type_toxoid(null)
 product_type_chemical(null)
 product_type_medical_device(null)
 product_type_chemical_name(null)
 product_type_medical_device_name(null)
 comparator(null)
 comparator_name(null)
 comparator_registered(null)
 comparator_countries(null)
 previous_dates(null)
 coordinating_investigators
 principal_investigators
 pharmacist
 sponsor_details
 gender
 details_of_sites
 placebos
 scopes
 organizations
 types_and_phases
 ecct_not_applicable0
 ecct_ref_number
 email_address(null)
 applicant_covering_letter(null)
 applicant_protocol(null)
 applicant_patient_information(null)
 applicant_investigators_brochure(null)
 applicant_investigators_cv(null)
 applicant_signed_declaration(null)
 applicant_financial_declaration(null)
 applicant_gmp_certificate(null)
 applicant_indemnity_cover(null)
 applicant_opinion_letter(null)
 applicant_approval_letter(null)
 applicant_statement(null)
 applicant_participating_countries(null)
 applicant_addendum(null)
 applicant_fees(null)
 declaration_applicant
 declaration_date1(null)
 declaration_principal_investigator
 declaration_date2(null)
 placebo_present
 study_objectives
 principal_inclusion_criteria
 principal_exclusion_criteria
 primary_end_points
 scope_diagnosis(null)
 scope_prophylaxis(null)
 scope_therapy(null)
 scope_safety(null)
 scope_efficacy(null)
 scope_pharmacokinetic(null)
 scope_pharmacodynamic(null)
 scope_bioequivalence(null)
 scope_dose_response(null)
 scope_pharmacogenetic(null)
 scope_pharmacogenomic(null)
 scope_pharmacoecomomic(null)
 scope_others(null)
 scope_others_specify(null)
 trial_human_pharmacology(null)
 trial_administration_humans(null)
 trial_bioequivalence_study(null)
 trial_other(null)
 trial_other_specify(null)
 trial_therapeutic_exploratory(null)
 trial_therapeutic_confirmatory(null)
 trial_therapeutic_use(null)
 design_controlled
 site_capacity(null)
 staff_numbers
 other_details_explanation
 other_details_regulatory_notapproved
 other_details_regulatory_approved
 other_details_regulatory_rejected
 other_details_regulatory_halted
 estimated_duration
 design_controlled_randomised
 design_controlled_open
 design_controlled_single_blind
 design_controlled_double_blind
 design_controlled_parallel_group
 design_controlled_cross_over
 design_controlled_other
 design_controlled_specify
 design_controlled_comparator
 design_controlled_other_medicinal
 design_controlled_placebo
 design_controlled_medicinal_other
 design_controlled_medicinal_specify
 single_site_member_state
 location_of_area
 multiple_sites_member_state
 multiple_countries
 multiple_member_states
 number_of_sites
 multi_country_list
 data_monitoring_committee
 total_enrolment_per_site
 total_participants_worldwide
 population_less_than_18_years
 population_utero
 population_preterm_newborn
 population_newborn
 population_infant_and_toddler
 population_children
 population_adolescent
 population_above_18
 population_adult
 population_elderly
 gender_female(null)
 gender_male(null)
 subjects_healthy
 subjects_patients
 subjects_vulnerable_populations
 subjects_women_child_bearing
 subjects_women_using_contraception
 subjects_pregnant_women
 subjects_nursing_women
 subjects_emergency_situation
 subjects_incapable_consent
 subjects_specify
 subjects_others
 subjects_others_specify
 investigator1_given_name(null)
 investigator1_middle_name(null)
 investigator1_family_name(null)
 investigator1_qualification(null)
 investigator1_professional_address(null)
 organisations_transferred_(null)
 number_participants
 notification
 approval_date(null)
 submitted1
 date_submitted2025-02-20 10:00:11
 modified2025-02-20 10:00:11
 created2025-02-20 09:56:59
 1(array)
 id52
 application_id196
 trial_status_id(null)
 abstract_of_study
 study_title
 laymans_summary
 protocol_no(null)
 version_no
 date_of_protocol(null)
 study_drug
 disease_condition
 product_type(null)
 product_type_biologicals(null)
 product_type_proteins(null)
 product_type_immunologicals(null)
 product_type_vaccines(null)
 product_type_hormones(null)
 product_type_toxoid(null)
 product_type_chemical(null)
 product_type_medical_device(null)
 product_type_chemical_name(null)
 product_type_medical_device_name(null)
 comparator(null)
 comparator_name(null)
 comparator_registered(null)
 comparator_countries(null)
 previous_dates(null)
 coordinating_investigators
 principal_investigators
 pharmacist
 sponsor_details
 gender
 details_of_sites
 placebos
 scopes
 organizations
 types_and_phases
 ecct_not_applicable0
 ecct_ref_number
 email_address(null)
 applicant_covering_letter(null)
 applicant_protocol(null)
 applicant_patient_information(null)
 applicant_investigators_brochure(null)
 applicant_investigators_cv(null)
 applicant_signed_declaration(null)
 applicant_financial_declaration(null)
 applicant_gmp_certificate(null)
 applicant_indemnity_cover(null)
 applicant_opinion_letter(null)
 applicant_approval_letter(null)
 applicant_statement(null)
 applicant_participating_countries(null)
 applicant_addendum(null)
 applicant_fees(null)
 declaration_applicant
 declaration_date1(null)
 declaration_principal_investigator
 declaration_date2(null)
 placebo_present
 study_objectives
 principal_inclusion_criteria
 principal_exclusion_criteria
 primary_end_points
 scope_diagnosis(null)
 scope_prophylaxis(null)
 scope_therapy(null)
 scope_safety(null)
 scope_efficacy(null)
 scope_pharmacokinetic(null)
 scope_pharmacodynamic(null)
 scope_bioequivalence(null)
 scope_dose_response(null)
 scope_pharmacogenetic(null)
 scope_pharmacogenomic(null)
 scope_pharmacoecomomic(null)
 scope_others(null)
 scope_others_specify(null)
 trial_human_pharmacology(null)
 trial_administration_humans(null)
 trial_bioequivalence_study(null)
 trial_other(null)
 trial_other_specify(null)
 trial_therapeutic_exploratory(null)
 trial_therapeutic_confirmatory(null)
 trial_therapeutic_use(null)
 design_controlled
 site_capacity(null)
 staff_numbers
 other_details_explanation
 other_details_regulatory_notapproved
 other_details_regulatory_approved
 other_details_regulatory_rejected
 other_details_regulatory_halted
 estimated_duration
 design_controlled_randomised
 design_controlled_open
 design_controlled_single_blind
 design_controlled_double_blind
 design_controlled_parallel_group
 design_controlled_cross_over
 design_controlled_other
 design_controlled_specify
 design_controlled_comparator
 design_controlled_other_medicinal
 design_controlled_placebo
 design_controlled_medicinal_other
 design_controlled_medicinal_specify
 single_site_member_state
 location_of_area
 multiple_sites_member_state
 multiple_countries
 multiple_member_states
 number_of_sites
 multi_country_list
 data_monitoring_committee
 total_enrolment_per_site
 total_participants_worldwide
 population_less_than_18_years
 population_utero
 population_preterm_newborn
 population_newborn
 population_infant_and_toddler
 population_children
 population_adolescent
 population_above_18
 population_adult
 population_elderly
 gender_female(null)
 gender_male(null)
 subjects_healthy
 subjects_patients
 subjects_vulnerable_populations
 subjects_women_child_bearing
 subjects_women_using_contraception
 subjects_pregnant_women
 subjects_nursing_women
 subjects_emergency_situation
 subjects_incapable_consent
 subjects_specify
 subjects_others
 subjects_others_specify
 investigator1_given_name(null)
 investigator1_middle_name(null)
 investigator1_family_name(null)
 investigator1_qualification(null)
 investigator1_professional_address(null)
 organisations_transferred_(null)
 number_participants
 notification
 approval_date(null)
 submitted1
 date_submitted2025-02-20 10:08:30
 modified2025-02-20 10:08:30
 created2025-02-20 10:00:19
 InvestigatorContact(array)
 0(array)
 id112
 application_id196
 given_nameAlan Short
 middle_nameCalvin Flynn
 family_nameNoble Kirk
 qualificationMagni voluptas sed iste consequatur Impedit excepturi tempor aut
 professional_addressSit cupiditate similique iure aut
 telephone+1 (258) 567-3581
 emailvyvyjumy@mailinator.com
 investigator_roleprincipal
 created2025-02-19 08:50:34
 modified2025-02-19 09:13:23
 ApplicationStage(array)
 0(array)
 id299
 application_id196
 stageScreening
 start_date2025-02-19
 statusComplete
 commentManager assign reviewer
 end_date2025-02-19
 created2025-02-19 09:13:23
 modified2025-02-19 09:13:23
 1(array)
 id300
 application_id196
 stageScreeningSubmission
 start_date2025-02-19
 statusComplete
 commentFrom Manager assign
 end_date2025-02-19
 created2025-02-19 09:17:30
 modified2025-02-19 09:17:30
 2(array)
 id301
 application_id196
 stageAssign
 start_date2025-02-19
 statusComplete
 commentManager final decision
 end_date2025-02-19
 created2025-02-19 09:17:30
 modified2025-02-19 09:17:30
 3(array)
 id302
 application_id196
 stageReview
 start_date2025-02-19
 statusComplete
 commentManager final decision
 end_date2025-02-19
 created2025-02-19 09:20:41
 modified2025-02-19 09:20:41
 4(array)
 id303
 application_id196
 stageReviewSubmission
 start_date2025-02-19
 statusComplete
 commentManager final decision
 end_date2025-03-28
 created2025-02-19 09:20:41
 modified2025-02-19 09:20:41
 5(array)
 id304
 application_id196
 stageFinalDecision
 start_date2025-02-19
 statusComplete
 commentManager final decision
 end_date2025-02-19
 created2025-02-19 09:20:41
 modified2025-02-19 09:20:41
 6(array)
 id305
 application_id196
 stageAnnualApproval
 start_date2025-02-19
 statusCurrent
 commentManager letter approve
 end_date2026-02-19
 created2025-02-19 09:20:41
 modified2025-02-19 09:20:41
 Pharmacist(array)
 0(array)
 id48
 application_id196
 reg_no793
 given_nameTaShya Harrell
 premise_nameKendall Kramer
 qualificationNon qui soluta tenetur molestiae eu vel sunt deleniti nisi similique sunt itaque autem in ad earum ullam aut
 professional_addressAut velit sequi explicabo Aute qui nobis voluptatibus pariatur Enim pariatur Quia aspernatur repudiandae exercitationem
 valid_year2000
 mobile452
 telephone+1 (354) 451-4116
 emailkucuvac@mailinator.com
 created2025-02-19 08:52:20
 modified2025-02-19 09:13:23
 EthicalCommittee(array)
 0(array)
 id49
 application_id196
 ethical_committeeKenyatta University
 submission_date29-07-2017
 erc_number157
 initial_approval16-04-1974
 created2025-02-19 08:52:20
 modified2025-02-19 09:13:23
 AnnualLetter(array)
 0(array)
 id79
 application_id196
 approval_noECCT/25/02/06/2025(50)
 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/25/02/06/2025(50) 19th February 2025 , Principal Investigator ECCT/25/02/06, Sit cupiditate similique iure aut, Dear Sir/Madam, Re: ECCT/25/02/06 : Initial Approval; sample Test Input Voluptatem Doloremque in amet. 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="http://45.79.161.190:8080/attachments/download/1737">line_list_of_all_client_2025_02_18_07_49_27.xls</a> dated: 19th February 2025 Version 1 2. The Study Protocol <a href="http://45.79.161.190:8080/attachments/download/1738">art_monthly_report_2025_02_18_07_55_57.xls</a> dated: 19th February 2025 3. 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/1744">art_monthly_report_2025_02_17_11_53_20_6.xls</a> dated: 19th February 2025 4. Patient Information leaflet and Informed consent form <a href="http://45.79.161.190:8080/attachments/download/1745">art_monthly_report_2025_02_18_07_55_57_4.xls</a> dated: 19th February 2025 5. Investigators Brochure/Package inserts <a href="http://45.79.161.190:8080/attachments/download/1746">line_list_of_all_client_2025_02_17_12_10_38_23.xls</a> dated: 19th February 2025 6. Investigational Medicinal Product Dossier (IMPD) <a href="http://45.79.161.190:8080/attachments/download/1747">art_monthly_report_2025_02_18_07_55_57_5.xls</a> dated: 19th February 2025 7. 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/1748">art_monthly_report_2025_02_18_07_55_57_6.xls</a> dated: 19th February 2025 8. Stability data of the investigational product <a href="http://45.79.161.190:8080/attachments/download/1749">line_list_of_all_client_2025_02_17_12_10_38_24.xls</a> dated: 19th February 2025 9. GMP certificate of the investigational product from the site of manufacture <a href="http://45.79.161.190:8080/attachments/download/1750">line_list_of_all_client_2025_02_17_12_10_38_25.xls</a> dated: 19th February 2025 10. Certificate of Analysis of the investigational product <a href="http://45.79.161.190:8080/attachments/download/1751">art_monthly_report_2025_02_18_07_55_57_7.xls</a> dated: 19th February 2025 Version 2 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/1752">art_monthly_report_2025_02_18_07_55_57_8.xls</a> dated: 19th February 2025 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/1764">art_monthly_report_2025_02_18_07_55_57_13.xls</a> dated: 19th February 2025 13. Evidence of contractual agreement between sponsor and Principal Investigator. <a href="http://45.79.161.190:8080/attachments/download/1763">line_list_of_all_client_2025_02_17_12_10_38_32.xls</a> dated: 19th February 2025 14. Evidence of recent GCP training of the core study staff <a href="http://45.79.161.190:8080/attachments/download/1762">art_monthly_report_2025_02_18_07_55_57_12.xls</a> dated: 19th February 2025 15. DSMB Charter including the composition and meeting schedule <a href="http://45.79.161.190:8080/attachments/download/1761">line_list_of_all_client_2025_02_17_12_10_38_31.xls</a> dated: 19th February 2025 16. Detailed budget of the study <a href="http://45.79.161.190:8080/attachments/download/1760">art_monthly_report_2025_02_18_07_55_57_11.xls</a> dated: 19th February 2025 17. Financial declaration by Sponsor and/or PI http://45.79.161.190:8080/admin/attachments/download/1736 <a href="http://45.79.161.190:8080/attachments/download/1759">line_list_of_all_client_2025_02_17_12_10_38_30.xls</a> dated: 19th February 2025 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. http://45.79.161.190:8080/admin/attachments/download/1732 <a href="http://45.79.161.190:8080/attachments/download/1758">line_list_of_all_client_2025_02_17_12_10_38_29.xls</a> dated: 19th February 2025 19. Indemnity cover for PI, investigators and study Pharmacist. <a href="http://45.79.161.190:8080/attachments/download/1757">line_list_of_all_client_2025_02_17_12_10_38_28.xls</a> dated: 19th February 2025 20. Clinical Trials Insurance cover for study participants <a href="http://45.79.161.190:8080/attachments/download/1756">line_list_of_all_client_2025_02_17_12_10_38_27.xls</a> dated: 19th February 2025 21. Copy of favorable opinion letter from the local Ethics Review Committee (ERC). <a href="http://45.79.161.190:8080/attachments/download/1755">art_monthly_report_2025_02_18_07_55_57_10.xls</a> dated: 19th February 2025 22. Copy of current Practice Licenses for the Investigators and study Pharmacist <a href="http://45.79.161.190:8080/attachments/download/1754">line_list_of_all_client_2025_02_17_12_10_38_26.xls</a> dated: 19th February 2025 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/1753">art_monthly_report_2025_02_18_07_55_57_9.xls</a> dated: 19th February 2025 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/1743">art_monthly_report_2025_02_18_07_55_57_3.xls</a> dated: 19th February 2025 25. 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/1742">art_monthly_report_2025_02_18_07_55_57_2.xls</a> dated: 19th February 2025 26. Payment of fees <a href="http://45.79.161.190:8080/attachments/download/1741">line_list_of_all_client_2025_02_17_12_10_38_22.xls</a> dated: 19th February 2025 27. Statistical Analysis Plan <a href="http://45.79.161.190:8080/attachments/download/1740">line_list_of_all_client_2025_02_18_07_49_27_3.xls</a> 28. Signed Checklist <a href="http://45.79.161.190:8080/attachments/download/1739">line_list_of_all_client_2025_02_18_07_49_27_2.xls</a> dated: 19th February 2025 </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: Test Input ECCT/25/02/06. 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 19th February 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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
 approvermanager
 approval_date19-02-2025
 expiry_date19-02-2026
 statusapproved
 deleted0
 deleted_date(null)
 created2025-02-19 09:20:41
 modified2025-02-28 14:27:35
 1(array)
 id80
 application_id196
 approval_noECCT/25/02/06/2025(51)
 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/25/02/06/2025(51) 21st February 2025 , Principal Investigator ECCT/25/02/06, Sit cupiditate similique iure aut, Dear Sir/Madam, Re: ECCT/25/02/06 : Initial Approval; Test Input Voluptatem Doloremque in amet. 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="http://45.79.161.190:8080/attachments/download/1737">line_list_of_all_client_2025_02_18_07_49_27.xls</a> dated: 19th February 2025 Version 1 2. The Study Protocol <a href="http://45.79.161.190:8080/attachments/download/1738">art_monthly_report_2025_02_18_07_55_57.xls</a> dated: 19th February 2025 3. 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/1744">art_monthly_report_2025_02_17_11_53_20_6.xls</a> dated: 19th February 2025 4. Patient Information leaflet and Informed consent form <a href="http://45.79.161.190:8080/attachments/download/1745">art_monthly_report_2025_02_18_07_55_57_4.xls</a> dated: 19th February 2025 5. Investigators Brochure/Package inserts <a href="http://45.79.161.190:8080/attachments/download/1746">line_list_of_all_client_2025_02_17_12_10_38_23.xls</a> dated: 19th February 2025 6. Investigational Medicinal Product Dossier (IMPD) <a href="http://45.79.161.190:8080/attachments/download/1747">art_monthly_report_2025_02_18_07_55_57_5.xls</a> dated: 19th February 2025 7. 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/1748">art_monthly_report_2025_02_18_07_55_57_6.xls</a> dated: 19th February 2025 8. Stability data of the investigational product <a href="http://45.79.161.190:8080/attachments/download/1749">line_list_of_all_client_2025_02_17_12_10_38_24.xls</a> dated: 19th February 2025 9. GMP certificate of the investigational product from the site of manufacture <a href="http://45.79.161.190:8080/attachments/download/1750">line_list_of_all_client_2025_02_17_12_10_38_25.xls</a> dated: 19th February 2025 10. Certificate of Analysis of the investigational product <a href="http://45.79.161.190:8080/attachments/download/1751">art_monthly_report_2025_02_18_07_55_57_7.xls</a> dated: 19th February 2025 Version 2 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/1752">art_monthly_report_2025_02_18_07_55_57_8.xls</a> dated: 19th February 2025 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/1764">art_monthly_report_2025_02_18_07_55_57_13.xls</a> dated: 19th February 2025 13. Evidence of contractual agreement between sponsor and Principal Investigator. <a href="http://45.79.161.190:8080/attachments/download/1763">line_list_of_all_client_2025_02_17_12_10_38_32.xls</a> dated: 19th February 2025 14. Evidence of recent GCP training of the core study staff <a href="http://45.79.161.190:8080/attachments/download/1762">art_monthly_report_2025_02_18_07_55_57_12.xls</a> dated: 19th February 2025 15. DSMB Charter including the composition and meeting schedule <a href="http://45.79.161.190:8080/attachments/download/1761">line_list_of_all_client_2025_02_17_12_10_38_31.xls</a> dated: 19th February 2025 16. Detailed budget of the study <a href="http://45.79.161.190:8080/attachments/download/1760">art_monthly_report_2025_02_18_07_55_57_11.xls</a> dated: 19th February 2025 17. Financial declaration by Sponsor and/or PI http://45.79.161.190:8080/admin/attachments/download/1736 <a href="http://45.79.161.190:8080/attachments/download/1759">line_list_of_all_client_2025_02_17_12_10_38_30.xls</a> dated: 19th February 2025 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. http://45.79.161.190:8080/admin/attachments/download/1732 <a href="http://45.79.161.190:8080/attachments/download/1758">line_list_of_all_client_2025_02_17_12_10_38_29.xls</a> dated: 19th February 2025 19. Indemnity cover for PI, investigators and study Pharmacist. <a href="http://45.79.161.190:8080/attachments/download/1757">line_list_of_all_client_2025_02_17_12_10_38_28.xls</a> dated: 19th February 2025 20. Clinical Trials Insurance cover for study participants <a href="http://45.79.161.190:8080/attachments/download/1756">line_list_of_all_client_2025_02_17_12_10_38_27.xls</a> dated: 19th February 2025 21. Copy of favorable opinion letter from the local Ethics Review Committee (ERC). <a href="http://45.79.161.190:8080/attachments/download/1755">art_monthly_report_2025_02_18_07_55_57_10.xls</a> dated: 19th February 2025 22. Copy of current Practice Licenses for the Investigators and study Pharmacist <a href="http://45.79.161.190:8080/attachments/download/1754">line_list_of_all_client_2025_02_17_12_10_38_26.xls</a> dated: 19th February 2025 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/1753">art_monthly_report_2025_02_18_07_55_57_9.xls</a> dated: 19th February 2025 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/1743">art_monthly_report_2025_02_18_07_55_57_3.xls</a> dated: 19th February 2025 25. 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/1742">art_monthly_report_2025_02_18_07_55_57_2.xls</a> dated: 19th February 2025 26. Payment of fees <a href="http://45.79.161.190:8080/attachments/download/1741">line_list_of_all_client_2025_02_17_12_10_38_22.xls</a> dated: 19th February 2025 27. Statistical Analysis Plan <a href="http://45.79.161.190:8080/attachments/download/1740">line_list_of_all_client_2025_02_18_07_49_27_3.xls</a> 28. Signed Checklist <a href="http://45.79.161.190:8080/attachments/download/1739">line_list_of_all_client_2025_02_18_07_49_27_2.xls</a> dated: 19th February 2025 </div> After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials notes the following: Trial category workspace Amet illum labore Trial category comments Ab nisi omnis qui ea Trial phase workspace Consequatur repudian Trial phase comments (if in disagreement with the study phase proposed): Est in sed veritatis Therapeutic condition workspace Aut aperiam suscipit Brief description of the disease Reprehenderit delect 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 Est temporibus corr Assessor’s discussion on the clinical development: Molestiae minus sit Consider what is new in this trial, the clinical relevance, and the medical need that the trial aims to address Dignissimos amet ex Clinical Trial Rationale comments Quae voluptatum debi Consider if there are established primary endpoints for this type of study/indication, do they match the goals, are they validated? Fuga Alias ut volup Primary objectives comments Possimus explicabo Secondary objectives workspace Magni molestias omni Secondary objectives comments Mollitia officia sap Study population workspace Voluptatem excepteur Study population comments Eos in rerum nisi la Take also into consideration the gender and age allocation of participants, and determine whether a specific group is excluded or underrepresented Ex nostrum officia v Inclusion criteria comments Ab quas velit labori 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 Ut quisquam ea quaer Exclusion criteria comments Non quia debitis ape The inclusion of vulnerable population is justifiable only if this information cannot be obtained from nonâ€‘vulnerable populations For incapacitated or minor participants, the trial should offer some direct benefit to the tem or to the population that they represent Qui error amet cons Vulnerable populations comments Quis enim illum id 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 Pariatur Expedita n Study plan and design comments Quam odit est numqua Consider the dose(s)/dose steps, dose rationale, route of administration, schedule, treatment duration, and dose modifications Voluptatem Exceptur Study treatment comments Et sit omnis labore Comparator IMP(s) workspace Consequatur Eum mag Comparator IMP(s) comments Delectus debitis et Placebo workspace Repudiandae rem est Placebo comments Est laboriosam beat Auxilliary medicinal product(s) workspace Repudiandae nesciunt Auxilliary medicinal product(s) comments Vitae ea veniam nos Additional considerations workspace Aut sed officia ut d Additional considerations comments Elit distinctio Qu 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 Et distinctio Omnis Safety comments In omnis porro offic Blinding and unblinding workspace Eius corporis aliqua Blinding and unblinding comments Anim assumenda elit Contraception measures workspace Accusantium omnis en Contraception measures comments Sint Nam et enim qu Discontinuation criteria workspace Corrupti dolorem in Discontinuation criteria comments Laborum est iste cil Other concomitant workspace Vitae nostrud perfer Other concomitant comments Distinctio Facere i Safety and Monitoring workspace Sed veritatis autem Safety and Monitoring comments Sint dolor itaque v Reference Safety Information workspace Magnam aute a et imp Reference Safety Information comments Quibusdam et modi no Data Safety Monitoring Committee workspace Minim adipisicing an Data Safety Monitoring Committee comments Nulla culpa cum ex o Definition of the end of the trial workspace Cum est voluptatem e Definition of the end of the trial comments Consectetur accusan Biological samples used in the study workspace Sequi id itaque qui Biological samples used in the study comments Provident dolor et Data protection workspace Eaque expedita eos Data protection comments Voluptatem rerum bla Recruitment and informed consent procedures workspace Vero consequatur Oc Recruitment and informed consent procedures comment Obcaecati nisi neces Benefit/risk assessment workspace Recusandae Quidem s Comments on the benefit/risk: Sunt dolorem repreh Assessor’s overall conclusions workspace Ad laboris optio vo Overall comment/ conclusion on the clinical assessment: Dolor quia fugiat ev 1.5.1 REQUESTS FOR ADDITIONAL INFORMATION Voluptatem ut molest The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study: Test Input ECCT/25/02/06. 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 21st February 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 
 qrcodePD94bWwgdmVyc2lvbj0iMS4wIiBlbmNvZGluZz0iVVRGLTgiPz4KPHN2ZyB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciIHZlcnNpb249IjEuMSIgd2lkdGg9IjE1MCIgaGVpZ2h0PSIxNTAiIHZpZXdCb3g9IjAgMCAxNTAgMTUwIj48cmVjdCB4PSIwIiB5PSIwIiB3aWR0aD0iMTUwIiBoZWlnaHQ9IjE1MCIgZmlsbD0iI2ZmZmZmZiIvPjxnIHRyYW5zZm9ybT0ic2NhbGUoNC41NDUpIj48ZyB0cmFuc2Zvcm09InRyYW5zbGF0ZSgwLDApIj48cGF0aCBmaWxsLXJ1bGU9ImV2ZW5vZGQiIGQ9Ik05IDBMOSAxTDEwIDFMMTAgM0w5IDNMOSAyTDggMkw4IDhMOSA4TDkgOUwxMCA5TDEwIDhMMTEgOEwxMSAxMUwxMCAxMUwxMCAxMEw4IDEwTDggOUw3IDlMNyA4TDIgOEwyIDlMMSA5TDEgOEwwIDhMMCA5TDEgOUwxIDEwTDAgMTBMMCAxMUwxIDExTDEgMTJMMCAxMkwwIDE1TDEgMTVMMSAxM0wyIDEzTDIgMTVMMyAxNUwzIDE2TDIgMTZMMiAxN0wxIDE3TDEgMTZMMCAxNkwwIDE4TDQgMThMNCAyMEwzIDIwTDMgMjFMMiAyMUwyIDIwTDEgMjBMMSAxOUwwIDE5TDAgMjVMMSAyNUwxIDIyTDIgMjJMMiAyM0wzIDIzTDMgMjRMNSAyNEw1IDI1TDcgMjVMNyAyNEw1IDI0TDUgMjNMMyAyM0wzIDIxTDQgMjFMNCAyMkw1IDIyTDUgMjFMNCAyMUw0IDIwTDYgMjBMNiAyMUw3IDIxTDcgMjJMNiAyMkw2IDIzTDggMjNMOCAyMkw5IDIyTDkgMjFMMTEgMjFMMTEgMjJMMTAgMjJMMTAgMjNMOSAyM0w5IDI0TDEwIDI0TDEwIDI2TDExIDI2TDExIDI3TDEwIDI3TDEwIDI4TDkgMjhMOSAyN0w4IDI3TDggMzFMOSAzMUw5IDMwTDEwIDMwTDEwIDI5TDExIDI5TDExIDMxTDEyIDMxTDEyIDI4TDExIDI4TDExIDI3TDEyIDI3TDEyIDI2TDExIDI2TDExIDI0TDEwIDI0TDEwIDIzTDEyIDIzTDEyIDI0TDEzIDI0TDEzIDI2TDE0IDI2TDE0IDI3TDEzIDI3TDEzIDMyTDEyIDMyTDEyIDMzTDE0IDMzTDE0IDMyTDE1IDMyTDE1IDMxTDE0IDMxTDE0IDI3TDE2IDI3TDE2IDI4TDE3IDI4TDE3IDI1TDE5IDI1TDE5IDI2TDE4IDI2TDE4IDI3TDE5IDI3TDE5IDI2TDIwIDI2TDIwIDI3TDIxIDI3TDIxIDI4TDIwIDI4TDIwIDI5TDE5IDI5TDE5IDI4TDE4IDI4TDE4IDI5TDE5IDI5TDE5IDMwTDE4IDMwTDE4IDMyTDE3IDMyTDE3IDMxTDE2IDMxTDE2IDMyTDE3IDMyTDE3IDMzTDIxIDMzTDIxIDMyTDIyIDMyTDIyIDMxTDIzIDMxTDIzIDMzTDMwIDMzTDMwIDMyTDMxIDMyTDMxIDMzTDMyIDMzTDMyIDMyTDMxIDMyTDMxIDMwTDMzIDMwTDMzIDI5TDMwIDI5TDMwIDI4TDMyIDI4TDMyIDI2TDMzIDI2TDMzIDI1TDMyIDI1TDMyIDI2TDMxIDI2TDMxIDI1TDMwIDI1TDMwIDI0TDMxIDI0TDMxIDIzTDMyIDIzTDMyIDI0TDMzIDI0TDMzIDIzTDMyIDIzTDMyIDIyTDMzIDIyTDMzIDIwTDMxIDIwTDMxIDE5TDMyIDE5TDMyIDE3TDMzIDE3TDMzIDE2TDMyIDE2TDMyIDE3TDI5IDE3TDI5IDE2TDMxIDE2TDMxIDE1TDMyIDE1TDMyIDE0TDMzIDE0TDMzIDExTDMyIDExTDMyIDEwTDMzIDEwTDMzIDlMMzIgOUwzMiAxMEwzMSAxMEwzMSA4TDI2IDhMMjYgOUwyNSA5TDI1IDVMMjQgNUwyNCA0TDI1IDRMMjUgM0wyNCAzTDI0IDJMMjUgMkwyNSAwTDIyIDBMMjIgMUwyMSAxTDIxIDNMMjAgM0wyMCAyTDE4IDJMMTggMEwxNiAwTDE2IDFMMTUgMUwxNSAwTDEzIDBMMTMgMkwxMiAyTDEyIDBaTTE5IDBMMTkgMUwyMCAxTDIwIDBaTTE2IDFMMTYgMkwxNCAyTDE0IDNMMTMgM0wxMyA0TDEyIDRMMTIgMkwxMSAyTDExIDNMMTAgM0wxMCA0TDkgNEw5IDVMMTAgNUwxMCA2TDkgNkw5IDdMMTAgN0wxMCA2TDExIDZMMTEgOEwxMiA4TDEyIDExTDExIDExTDExIDEzTDEwIDEzTDEwIDEyTDkgMTJMOSAxMUw4IDExTDggMTJMOSAxMkw5IDE0TDggMTRMOCAxNUw5IDE1TDkgMTZMNyAxNkw3IDE1TDYgMTVMNiAxNEw3IDE0TDcgMTNMNiAxM0w2IDE0TDUgMTRMNSAxNUw2IDE1TDYgMTZMNSAxNkw1IDE3TDQgMTdMNCAxOEw1IDE4TDUgMTdMNiAxN0w2IDE4TDggMThMOCAxOUw5IDE5TDkgMjBMMTIgMjBMMTIgMjFMMTQgMjFMMTQgMjJMMTMgMjJMMTMgMjRMMTQgMjRMMTQgMjZMMTYgMjZMMTYgMjVMMTcgMjVMMTcgMjRMMTggMjRMMTggMjJMMTcgMjJMMTcgMjFMMTkgMjFMMTkgMjVMMjAgMjVMMjAgMjZMMjEgMjZMMjEgMjdMMjIgMjdMMjIgMjZMMjMgMjZMMjMgMjVMMjQgMjVMMjQgMjRMMjUgMjRMMjUgMjNMMjQgMjNMMjQgMjJMMjYgMjJMMjYgMjRMMjkgMjRMMjkgMjFMMjcgMjFMMjcgMjBMMjggMjBMMjggMThMMjkgMThMMjkgMTlMMzAgMTlMMzAgMThMMjkgMThMMjkgMTdMMjggMTdMMjggMThMMjIgMThMMjIgMTdMMjcgMTdMMjcgMTZMMjkgMTZMMjkgMTVMMzAgMTVMMzAgMTRMMzEgMTRMMzEgMTJMMzAgMTJMMzAgMTRMMjkgMTRMMjkgMTNMMjggMTNMMjggMTBMMjkgMTBMMjkgMTFMMzAgMTFMMzAgMTBMMjkgMTBMMjkgOUwyOCA5TDI4IDEwTDIzIDEwTDIzIDExTDIyIDExTDIyIDEwTDIxIDEwTDIxIDlMMjQgOUwyNCA4TDIxIDhMMjEgN0wyMiA3TDIyIDZMMjMgNkwyMyA3TDI0IDdMMjQgNUwyMyA1TDIzIDRMMjIgNEwyMiAzTDIxIDNMMjEgNEwxOSA0TDE5IDNMMTcgM0wxNyA0TDE2IDRMMTYgMkwxNyAyTDE3IDFaTTIyIDFMMjIgMkwyNCAyTDI0IDFaTTE0IDNMMTQgNEwxNSA0TDE1IDVMMTQgNUwxNCA4TDEzIDhMMTMgNkwxMiA2TDEyIDRMMTEgNEwxMSA2TDEyIDZMMTIgOEwxMyA4TDEzIDlMMTYgOUwxNiAxMEwxNSAxMEwxNSAxMUwxNCAxMUwxNCAxMkwxNSAxMkwxNSAxMUwxNiAxMUwxNiAxMkwxNyAxMkwxNyAxMUwxNiAxMUwxNiAxMEwxNyAxMEwxNyA5TDE5IDlMMTkgMTBMMTggMTBMMTggMTFMMTkgMTFMMTkgMTBMMjAgMTBMMjAgOUwyMSA5TDIxIDhMMjAgOEwyMCA5TDE5IDlMMTkgNEwxNyA0TDE3IDVMMTYgNUwxNiA0TDE1IDRMMTUgM1pNMjEgNEwyMSA1TDIwIDVMMjAgN0wyMSA3TDIxIDZMMjIgNkwyMiA0Wk0xNyA1TDE3IDdMMTYgN0wxNiA2TDE1IDZMMTUgN0wxNiA3TDE2IDlMMTcgOUwxNyA4TDE4IDhMMTggNVpNMiA5TDIgMTBMMSAxMEwxIDExTDQgMTFMNCAxMEw1IDEwTDUgMTFMNiAxMUw2IDEyTDcgMTJMNyAxMUw2IDExTDYgMTBMNyAxMEw3IDlMNiA5TDYgMTBMNSAxMEw1IDlMNCA5TDQgMTBMMyAxMEwzIDlaTTEyIDExTDEyIDEzTDExIDEzTDExIDE0TDEyIDE0TDEyIDEzTDEzIDEzTDEzIDExWk0yMSAxMUwyMSAxMkwyMiAxMkwyMiAxM0wyMCAxM0wyMCAxNEwxOCAxNEwxOCAxNkwxNyAxNkwxNyAxNUwxNiAxNUwxNiAxNkwxNyAxNkwxNyAxN0wxNiAxN0wxNiAxOEwxNCAxOEwxNCAyMUwxNSAyMUwxNSAyNUwxNiAyNUwxNiAyM0wxNyAyM0wxNyAyMkwxNiAyMkwxNiAyMUwxNyAyMUwxNyAyMEwxOSAyMEwxOSAyMUwyMCAyMUwyMCAyMEwxOSAyMEwxOSAxOUwxOCAxOUwxOCAxN0wxOSAxN0wxOSAxOEwyMCAxOEwyMCAxOUwyMSAxOUwyMSAyMEwyNCAyMEwyNCAyMUwyMyAyMUwyMyAyMkwyNCAyMkwyNCAyMUwyNSAyMUwyNSAyMEwyNyAyMEwyNyAxOUwyNSAxOUwyNSAyMEwyNCAyMEwyNCAxOUwyMiAxOUwyMiAxOEwyMCAxOEwyMCAxN0wyMSAxN0wyMSAxNkwyMiAxNkwyMiAxNUwyMyAxNUwyMyAxNEwyNCAxNEwyNCAxMkwyNSAxMkwyNSAxNUwyNiAxNUwyNiAxNEwyNyAxNEwyNyAxM0wyNiAxM0wyNiAxMkwyNyAxMkwyNyAxMUwyNiAxMUwyNiAxMkwyNSAxMkwyNSAxMUwyNCAxMUwyNCAxMkwyMiAxMkwyMiAxMVpNMiAxMkwyIDEzTDMgMTNMMyAxMlpNNCAxMkw0IDEzTDUgMTNMNSAxMlpNMTggMTJMMTggMTNMMTkgMTNMMTkgMTJaTTE0IDEzTDE0IDE0TDE3IDE0TDE3IDEzWk0zIDE0TDMgMTVMNCAxNUw0IDE0Wk05IDE0TDkgMTVMMTAgMTVMMTAgMTdMOCAxN0w4IDE4TDEwIDE4TDEwIDE5TDEyIDE5TDEyIDIwTDEzIDIwTDEzIDE5TDEyIDE5TDEyIDE4TDEzIDE4TDEzIDE3TDE1IDE3TDE1IDE1TDE0IDE1TDE0IDE2TDEyIDE2TDEyIDE1TDEwIDE1TDEwIDE0Wk0yMCAxNEwyMCAxNUwyMiAxNUwyMiAxNFpNNiAxNkw2IDE3TDcgMTdMNyAxNlpNMTEgMTZMMTEgMTdMMTAgMTdMMTAgMThMMTEgMThMMTEgMTdMMTIgMTdMMTIgMTZaTTYgMTlMNiAyMEw3IDIwTDcgMTlaTTE2IDE5TDE2IDIwTDE3IDIwTDE3IDE5Wk0zMCAyMEwzMCAyMUwzMSAyMUwzMSAyMkwzMiAyMkwzMiAyMUwzMSAyMUwzMSAyMFpNMjEgMjFMMjEgMjRMMjAgMjRMMjAgMjVMMjEgMjVMMjEgMjRMMjQgMjRMMjQgMjNMMjIgMjNMMjIgMjFaTTI2IDIxTDI2IDIyTDI3IDIyTDI3IDIzTDI4IDIzTDI4IDIyTDI3IDIyTDI3IDIxWk04IDI1TDggMjZMOSAyNkw5IDI1Wk0yNSAyNUwyNSAyOEwyOCAyOEwyOCAyNVpNMjkgMjVMMjkgMjhMMzAgMjhMMzAgMjVaTTI2IDI2TDI2IDI3TDI3IDI3TDI3IDI2Wk0yMyAyN0wyMyAyOEwyMSAyOEwyMSAyOUwyMCAyOUwyMCAzMEwxOSAzMEwxOSAzMkwyMSAzMkwyMSAzMUwyMiAzMUwyMiAyOUwyMyAyOUwyMyAzMEwyNCAzMEwyNCAzMkwyNSAzMkwyNSAzMUwyNiAzMUwyNiAzMEwyNyAzMEwyNyAyOUwyNCAyOUwyNCAyN1pNMTUgMjlMMTUgMzBMMTcgMzBMMTcgMjlaTTI4IDMwTDI4IDMxTDMwIDMxTDMwIDMwWk04IDMyTDggMzNMOSAzM0w5IDMyWk0xMCAzMkwxMCAzM0wxMSAzM0wxMSAzMlpNMCAwTDAgN0w3IDdMNyAwWk0xIDFMMSA2TDYgNkw2IDFaTTIgMkwyIDVMNSA1TDUgMlpNMjYgMEwyNiA3TDMzIDdMMzMgMFpNMjcgMUwyNyA2TDMyIDZMMzIgMVpNMjggMkwyOCA1TDMxIDVMMzEgMlpNMCAyNkwwIDMzTDcgMzNMNyAyNlpNMSAyN0wxIDMyTDYgMzJMNiAyN1pNMiAyOEwyIDMxTDUgMzFMNSAyOFoiIGZpbGw9IiMwMDAwMDAiLz48L2c+PC9nPjwvc3ZnPgo=
 approvermanager
 approval_date21-02-2025
 expiry_date21-02-2026
 statusapproved
 deleted0
 deleted_date(null)
 created2025-02-21 11:38:02
 modified2025-02-21 11:38:31
 2(array)
 id81
 application_id196
 approval_noECCT/3/2025-ECCT/25/02/06
 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/3/2025-ECCT/25/02/06 21 Feb 2025 Alan Short Calvin Flynn Noble Kirk, Principal Investigator ECCT/25/02/06, Sit cupiditate similique iure aut, Dear Sir/Madam, Re: ECCT/25/02/06 : Initial Approval; Test Input Voluptatem Doloremque in amet. 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/1737">line_list_of_all_client_2025_02_18_07_49_27.xls</a> dated dated: 19th February 2025 Version 1 2. The Study Protocol <a href="/attachments/download/1738">art_monthly_report_2025_02_18_07_55_57.xls</a> dated dated: 19th February 2025 3. Registration of the study at Pan African Clinical Trials Registry https://pactr.samrc.ac.za <a href="/attachments/download/1744">art_monthly_report_2025_02_17_11_53_20_6.xls</a> dated dated: 19th February 2025 4. Patient Information leaflet and Informed consent form <a href="/attachments/download/1745">art_monthly_report_2025_02_18_07_55_57_4.xls</a> dated dated: 19th February 2025 5. Investigators Brochure/Package inserts <a href="/attachments/download/1746">line_list_of_all_client_2025_02_17_12_10_38_23.xls</a> dated dated: 19th February 2025 6. Investigational Medicinal Product Dossier (IMPD) <a href="/attachments/download/1747">art_monthly_report_2025_02_18_07_55_57_5.xls</a> dated dated: 19th February 2025 7. Adequate data and information from previous studies and Phases to support carrying out of the current study <a href="/attachments/download/1748">art_monthly_report_2025_02_18_07_55_57_6.xls</a> dated dated: 19th February 2025 8. Stability data of the investigational product <a href="/attachments/download/1749">line_list_of_all_client_2025_02_17_12_10_38_24.xls</a> dated dated: 19th February 2025 9. GMP certificate of the investigational product from the site of manufacture <a href="/attachments/download/1750">line_list_of_all_client_2025_02_17_12_10_38_25.xls</a> dated dated: 19th February 2025 10. Certificate of Analysis of the investigational product <a href="/attachments/download/1751">art_monthly_report_2025_02_18_07_55_57_7.xls</a> dated dated: 19th February 2025 Version 2 11. Pictorial Sample of the investigational products. This sample should include the text of the labeling to be used <a href="/attachments/download/1752">art_monthly_report_2025_02_18_07_55_57_8.xls</a> dated dated: 19th February 2025 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/1764">art_monthly_report_2025_02_18_07_55_57_13.xls</a> dated dated: 19th February 2025 13. Evidence of contractual agreement between sponsor and Principal Investigator. <a href="/attachments/download/1763">line_list_of_all_client_2025_02_17_12_10_38_32.xls</a> dated dated: 19th February 2025 14. Evidence of recent GCP training of the core study staff <a href="/attachments/download/1762">art_monthly_report_2025_02_18_07_55_57_12.xls</a> dated dated: 19th February 2025 15. DSMB Charter including the composition and meeting schedule <a href="/attachments/download/1761">line_list_of_all_client_2025_02_17_12_10_38_31.xls</a> dated dated: 19th February 2025 16. Detailed budget of the study <a href="/attachments/download/1760">art_monthly_report_2025_02_18_07_55_57_11.xls</a> dated dated: 19th February 2025 17. Financial declaration by Sponsor and/or PI http://45.79.161.190:8080/admin/attachments/download/1736 <a href="/attachments/download/1759">line_list_of_all_client_2025_02_17_12_10_38_30.xls</a> dated dated: 19th February 2025 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. http://45.79.161.190:8080/admin/attachments/download/1732 <a href="/attachments/download/1758">line_list_of_all_client_2025_02_17_12_10_38_29.xls</a> dated dated: 19th February 2025 19. Indemnity cover for PI, investigators and study Pharmacist. <a href="/attachments/download/1757">line_list_of_all_client_2025_02_17_12_10_38_28.xls</a> dated dated: 19th February 2025 20. Clinical Trials Insurance cover for study participants <a href="/attachments/download/1756">line_list_of_all_client_2025_02_17_12_10_38_27.xls</a> dated dated: 19th February 2025 21. Copy of favorable opinion letter from the local Ethics Review Committee (ERC). <a href="/attachments/download/1755">art_monthly_report_2025_02_18_07_55_57_10.xls</a> dated dated: 19th February 2025 22. Copy of current Practice Licenses for the Investigators and study Pharmacist <a href="/attachments/download/1754">line_list_of_all_client_2025_02_17_12_10_38_26.xls</a> dated dated: 19th February 2025 23. Copy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable <a href="/attachments/download/1753">art_monthly_report_2025_02_18_07_55_57_9.xls</a> dated dated: 19th February 2025 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/1743">art_monthly_report_2025_02_18_07_55_57_3.xls</a> dated dated: 19th February 2025 25. 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/1742">art_monthly_report_2025_02_18_07_55_57_2.xls</a> dated dated: 19th February 2025 26. Payment of fees <a href="/attachments/download/1741">line_list_of_all_client_2025_02_17_12_10_38_22.xls</a> dated dated: 19th February 2025 27. Statistical Analysis Plan <a href="/attachments/download/1740">line_list_of_all_client_2025_02_18_07_49_27_3.xls</a> dated 28. Signed Checklist <a href="/attachments/download/1739">line_list_of_all_client_2025_02_18_07_49_27_2.xls</a> dated dated: 19th February 2025 </div> After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials notes the following: Trial category workspace Amet illum labore Trial category comments Ab nisi omnis qui ea Trial phase workspace Consequatur repudian Trial phase comments (if in disagreement with the study phase proposed): Est in sed veritatis Therapeutic condition workspace Aut aperiam suscipit Brief description of the disease Reprehenderit delect 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 Est temporibus corr Assessor’s discussion on the clinical development: Molestiae minus sit Consider what is new in this trial, the clinical relevance, and the medical need that the trial aims to address Dignissimos amet ex Clinical Trial Rationale comments Quae voluptatum debi Consider if there are established primary endpoints for this type of study/indication, do they match the goals, are they validated? Fuga Alias ut volup Primary objectives comments Possimus explicabo Secondary objectives workspace Magni molestias omni Secondary objectives comments Mollitia officia sap Study population workspace Voluptatem excepteur Study population comments Eos in rerum nisi la Take also into consideration the gender and age allocation of participants, and determine whether a specific group is excluded or underrepresented Ex nostrum officia v Inclusion criteria comments Ab quas velit labori 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 Ut quisquam ea quaer Exclusion criteria comments Non quia debitis ape The inclusion of vulnerable population is justifiable only if this information cannot be obtained from nonâ€‘vulnerable populations For incapacitated or minor participants, the trial should offer some direct benefit to the tem or to the population that they represent Qui error amet cons Vulnerable populations comments Quis enim illum id 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 Pariatur Expedita n Study plan and design comments Quam odit est numqua Consider the dose(s)/dose steps, dose rationale, route of administration, schedule, treatment duration, and dose modifications Voluptatem Exceptur Study treatment comments Et sit omnis labore Comparator IMP(s) workspace Consequatur Eum mag Comparator IMP(s) comments Delectus debitis et Placebo workspace Repudiandae rem est Placebo comments Est laboriosam beat Auxilliary medicinal product(s) workspace Repudiandae nesciunt Auxilliary medicinal product(s) comments Vitae ea veniam nos Additional considerations workspace Aut sed officia ut d Additional considerations comments Elit distinctio Qu 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 Et distinctio Omnis Safety comments In omnis porro offic Blinding and unblinding workspace Eius corporis aliqua Blinding and unblinding comments Anim assumenda elit Contraception measures workspace Accusantium omnis en Contraception measures comments Sint Nam et enim qu Discontinuation criteria workspace Corrupti dolorem in Discontinuation criteria comments Laborum est iste cil Other concomitant workspace Vitae nostrud perfer Other concomitant comments Distinctio Facere i Safety and Monitoring workspace Sed veritatis autem Safety and Monitoring comments Sint dolor itaque v Reference Safety Information workspace Magnam aute a et imp Reference Safety Information comments Quibusdam et modi no Data Safety Monitoring Committee workspace Minim adipisicing an Data Safety Monitoring Committee comments Nulla culpa cum ex o Definition of the end of the trial workspace Cum est voluptatem e Definition of the end of the trial comments Consectetur accusan Biological samples used in the study workspace Sequi id itaque qui Biological samples used in the study comments Provident dolor et Data protection workspace Eaque expedita eos Data protection comments Voluptatem rerum bla Recruitment and informed consent procedures workspace Vero consequatur Oc Recruitment and informed consent procedures comment Obcaecati nisi neces Benefit/risk assessment workspace Recusandae Quidem s Comments on the benefit/risk: Sunt dolorem repreh Assessor’s overall conclusions workspace Ad laboris optio vo Overall comment/ conclusion on the clinical assessment: Dolor quia fugiat ev 1.5.1 REQUESTS FOR ADDITIONAL INFORMATION Voluptatem ut molest The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study: Test Input ECCT/25/02/06. 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 21st February 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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
 approvermanager
 approval_date21-02-2025
 expiry_date21-02-2026
 statusapproved
 deleted0
 deleted_date(null)
 created2025-02-21 12:06:22
 modified2025-02-21 12:08:14
 3(array)
 id82
 application_id196
 approval_noECCT/4/2025-ECCT/25/02/06
 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/4/2025-ECCT/25/02/06 21 Feb 2025 Alan Short Calvin Flynn Noble Kirk, Principal Investigator ECCT/25/02/06, Sit cupiditate similique iure aut, Dear Sir/Madam, Re: ECCT/25/02/06 : Initial Approval; Test Input Voluptatem Doloremque in amet. 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/1737">line_list_of_all_client_2025_02_18_07_49_27.xls</a> dated dated: 19th February 2025 Version 1 2. The Study Protocol <a href="/attachments/download/1738">art_monthly_report_2025_02_18_07_55_57.xls</a> dated dated: 19th February 2025 3. Registration of the study at Pan African Clinical Trials Registry https://pactr.samrc.ac.za <a href="/attachments/download/1744">art_monthly_report_2025_02_17_11_53_20_6.xls</a> dated dated: 19th February 2025 4. Patient Information leaflet and Informed consent form <a href="/attachments/download/1745">art_monthly_report_2025_02_18_07_55_57_4.xls</a> dated dated: 19th February 2025 5. Investigators Brochure/Package inserts <a href="/attachments/download/1746">line_list_of_all_client_2025_02_17_12_10_38_23.xls</a> dated dated: 19th February 2025 6. Investigational Medicinal Product Dossier (IMPD) <a href="/attachments/download/1747">art_monthly_report_2025_02_18_07_55_57_5.xls</a> dated dated: 19th February 2025 7. Adequate data and information from previous studies and Phases to support carrying out of the current study <a href="/attachments/download/1748">art_monthly_report_2025_02_18_07_55_57_6.xls</a> dated dated: 19th February 2025 8. Stability data of the investigational product <a href="/attachments/download/1749">line_list_of_all_client_2025_02_17_12_10_38_24.xls</a> dated dated: 19th February 2025 9. GMP certificate of the investigational product from the site of manufacture <a href="/attachments/download/1750">line_list_of_all_client_2025_02_17_12_10_38_25.xls</a> dated dated: 19th February 2025 10. Certificate of Analysis of the investigational product <a href="/attachments/download/1751">art_monthly_report_2025_02_18_07_55_57_7.xls</a> dated dated: 19th February 2025 Version 2 11. Pictorial Sample of the investigational products. This sample should include the text of the labeling to be used <a href="/attachments/download/1752">art_monthly_report_2025_02_18_07_55_57_8.xls</a> dated dated: 19th February 2025 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/1764">art_monthly_report_2025_02_18_07_55_57_13.xls</a> dated dated: 19th February 2025 13. Evidence of contractual agreement between sponsor and Principal Investigator. <a href="/attachments/download/1763">line_list_of_all_client_2025_02_17_12_10_38_32.xls</a> dated dated: 19th February 2025 14. Evidence of recent GCP training of the core study staff <a href="/attachments/download/1762">art_monthly_report_2025_02_18_07_55_57_12.xls</a> dated dated: 19th February 2025 15. DSMB Charter including the composition and meeting schedule <a href="/attachments/download/1761">line_list_of_all_client_2025_02_17_12_10_38_31.xls</a> dated dated: 19th February 2025 16. Detailed budget of the study <a href="/attachments/download/1760">art_monthly_report_2025_02_18_07_55_57_11.xls</a> dated dated: 19th February 2025 17. Financial declaration by Sponsor and/or PI http://45.79.161.190:8080/admin/attachments/download/1736 <a href="/attachments/download/1759">line_list_of_all_client_2025_02_17_12_10_38_30.xls</a> dated dated: 19th February 2025 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. http://45.79.161.190:8080/admin/attachments/download/1732 <a href="/attachments/download/1758">line_list_of_all_client_2025_02_17_12_10_38_29.xls</a> dated dated: 19th February 2025 19. Indemnity cover for PI, investigators and study Pharmacist. <a href="/attachments/download/1757">line_list_of_all_client_2025_02_17_12_10_38_28.xls</a> dated dated: 19th February 2025 20. Clinical Trials Insurance cover for study participants <a href="/attachments/download/1756">line_list_of_all_client_2025_02_17_12_10_38_27.xls</a> dated dated: 19th February 2025 21. Copy of favorable opinion letter from the local Ethics Review Committee (ERC). <a href="/attachments/download/1755">art_monthly_report_2025_02_18_07_55_57_10.xls</a> dated dated: 19th February 2025 22. Copy of current Practice Licenses for the Investigators and study Pharmacist <a href="/attachments/download/1754">line_list_of_all_client_2025_02_17_12_10_38_26.xls</a> dated dated: 19th February 2025 23. Copy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable <a href="/attachments/download/1753">art_monthly_report_2025_02_18_07_55_57_9.xls</a> dated dated: 19th February 2025 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/1743">art_monthly_report_2025_02_18_07_55_57_3.xls</a> dated dated: 19th February 2025 25. 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/1742">art_monthly_report_2025_02_18_07_55_57_2.xls</a> dated dated: 19th February 2025 26. Payment of fees <a href="/attachments/download/1741">line_list_of_all_client_2025_02_17_12_10_38_22.xls</a> dated dated: 19th February 2025 27. Statistical Analysis Plan <a href="/attachments/download/1740">line_list_of_all_client_2025_02_18_07_49_27_3.xls</a> dated 28. Signed Checklist <a href="/attachments/download/1739">line_list_of_all_client_2025_02_18_07_49_27_2.xls</a> dated dated: 19th February 2025 </div> After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials notes the following: Trial category workspace Amet illum labore Trial category comments Ab nisi omnis qui ea Trial phase workspace Consequatur repudian Trial phase comments (if in disagreement with the study phase proposed): Est in sed veritatis Therapeutic condition workspace Aut aperiam suscipit Brief description of the disease Reprehenderit delect 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 Est temporibus corr Assessor’s discussion on the clinical development: Molestiae minus sit Consider what is new in this trial, the clinical relevance, and the medical need that the trial aims to address Dignissimos amet ex Clinical Trial Rationale comments Quae voluptatum debi Consider if there are established primary endpoints for this type of study/indication, do they match the goals, are they validated? Fuga Alias ut volup Primary objectives comments Possimus explicabo Secondary objectives workspace Magni molestias omni Secondary objectives comments Mollitia officia sap Study population workspace Voluptatem excepteur Study population comments Eos in rerum nisi la Take also into consideration the gender and age allocation of participants, and determine whether a specific group is excluded or underrepresented Ex nostrum officia v Inclusion criteria comments Ab quas velit labori 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 Ut quisquam ea quaer Exclusion criteria comments Non quia debitis ape The inclusion of vulnerable population is justifiable only if this information cannot be obtained from nonâ€‘vulnerable populations For incapacitated or minor participants, the trial should offer some direct benefit to the tem or to the population that they represent Qui error amet cons Vulnerable populations comments Quis enim illum id 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 Pariatur Expedita n Study plan and design comments Quam odit est numqua Consider the dose(s)/dose steps, dose rationale, route of administration, schedule, treatment duration, and dose modifications Voluptatem Exceptur Study treatment comments Et sit omnis labore Comparator IMP(s) workspace Consequatur Eum mag Comparator IMP(s) comments Delectus debitis et Placebo workspace Repudiandae rem est Placebo comments Est laboriosam beat Auxilliary medicinal product(s) workspace Repudiandae nesciunt Auxilliary medicinal product(s) comments Vitae ea veniam nos Additional considerations workspace Aut sed officia ut d Additional considerations comments Elit distinctio Qu 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 Et distinctio Omnis Safety comments In omnis porro offic Blinding and unblinding workspace Eius corporis aliqua Blinding and unblinding comments Anim assumenda elit Contraception measures workspace Accusantium omnis en Contraception measures comments Sint Nam et enim qu Discontinuation criteria workspace Corrupti dolorem in Discontinuation criteria comments Laborum est iste cil Other concomitant workspace Vitae nostrud perfer Other concomitant comments Distinctio Facere i Safety and Monitoring workspace Sed veritatis autem Safety and Monitoring comments Sint dolor itaque v Reference Safety Information workspace Magnam aute a et imp Reference Safety Information comments Quibusdam et modi no Data Safety Monitoring Committee workspace Minim adipisicing an Data Safety Monitoring Committee comments Nulla culpa cum ex o Definition of the end of the trial workspace Cum est voluptatem e Definition of the end of the trial comments Consectetur accusan Biological samples used in the study workspace Sequi id itaque qui Biological samples used in the study comments Provident dolor et Data protection workspace Eaque expedita eos Data protection comments Voluptatem rerum bla Recruitment and informed consent procedures workspace Vero consequatur Oc Recruitment and informed consent procedures comment Obcaecati nisi neces Benefit/risk assessment workspace Recusandae Quidem s Comments on the benefit/risk: Sunt dolorem repreh Assessor’s overall conclusions workspace Ad laboris optio vo Overall comment/ conclusion on the clinical assessment: Dolor quia fugiat ev 1.5.1 REQUESTS FOR ADDITIONAL INFORMATION Voluptatem ut molest The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study: Test Input ECCT/25/02/06. 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 21st February 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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
 approvermanager
 approval_date21-02-2025
 expiry_date21-02-2026
 statusapproved
 deleted0
 deleted_date(null)
 created2025-02-21 12:09:04
 modified2025-02-21 12:09:32
 4(array)
 id83
 application_id196
 approval_noECCT/5/2025-ECCT/25/02/06
 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/5/2025-ECCT/25/02/06 21 Feb 2025 Alan Short Calvin Flynn Noble Kirk, Principal Investigator ECCT/25/02/06, Sit cupiditate similique iure aut, Dear Sir/Madam, Re: ECCT/25/02/06 : Initial Approval; Test Input Voluptatem Doloremque in amet. 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/1737">line_list_of_all_client_2025_02_18_07_49_27.xls</a> dated dated: 19th February 2025 Version 1 2. The Study Protocol <a href="/attachments/download/1738">art_monthly_report_2025_02_18_07_55_57.xls</a> dated dated: 19th February 2025 3. Registration of the study at Pan African Clinical Trials Registry https://pactr.samrc.ac.za <a href="/attachments/download/1744">art_monthly_report_2025_02_17_11_53_20_6.xls</a> dated dated: 19th February 2025 4. Patient Information leaflet and Informed consent form <a href="/attachments/download/1745">art_monthly_report_2025_02_18_07_55_57_4.xls</a> dated dated: 19th February 2025 5. Investigators Brochure/Package inserts <a href="/attachments/download/1746">line_list_of_all_client_2025_02_17_12_10_38_23.xls</a> dated dated: 19th February 2025 6. Investigational Medicinal Product Dossier (IMPD) <a href="/attachments/download/1747">art_monthly_report_2025_02_18_07_55_57_5.xls</a> dated dated: 19th February 2025 7. Adequate data and information from previous studies and Phases to support carrying out of the current study <a href="/attachments/download/1748">art_monthly_report_2025_02_18_07_55_57_6.xls</a> dated dated: 19th February 2025 8. Stability data of the investigational product <a href="/attachments/download/1749">line_list_of_all_client_2025_02_17_12_10_38_24.xls</a> dated dated: 19th February 2025 9. GMP certificate of the investigational product from the site of manufacture <a href="/attachments/download/1750">line_list_of_all_client_2025_02_17_12_10_38_25.xls</a> dated dated: 19th February 2025 10. Certificate of Analysis of the investigational product <a href="/attachments/download/1751">art_monthly_report_2025_02_18_07_55_57_7.xls</a> dated dated: 19th February 2025 Version 2 11. Pictorial Sample of the investigational products. This sample should include the text of the labeling to be used <a href="/attachments/download/1752">art_monthly_report_2025_02_18_07_55_57_8.xls</a> dated dated: 19th February 2025 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/1764">art_monthly_report_2025_02_18_07_55_57_13.xls</a> dated dated: 19th February 2025 13. Evidence of contractual agreement between sponsor and Principal Investigator. <a href="/attachments/download/1763">line_list_of_all_client_2025_02_17_12_10_38_32.xls</a> dated dated: 19th February 2025 14. Evidence of recent GCP training of the core study staff <a href="/attachments/download/1762">art_monthly_report_2025_02_18_07_55_57_12.xls</a> dated dated: 19th February 2025 15. DSMB Charter including the composition and meeting schedule <a href="/attachments/download/1761">line_list_of_all_client_2025_02_17_12_10_38_31.xls</a> dated dated: 19th February 2025 16. Detailed budget of the study <a href="/attachments/download/1760">art_monthly_report_2025_02_18_07_55_57_11.xls</a> dated dated: 19th February 2025 17. Financial declaration by Sponsor and/or PI http://45.79.161.190:8080/admin/attachments/download/1736 <a href="/attachments/download/1759">line_list_of_all_client_2025_02_17_12_10_38_30.xls</a> dated dated: 19th February 2025 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. http://45.79.161.190:8080/admin/attachments/download/1732 <a href="/attachments/download/1758">line_list_of_all_client_2025_02_17_12_10_38_29.xls</a> dated dated: 19th February 2025 19. Indemnity cover for PI, investigators and study Pharmacist. <a href="/attachments/download/1757">line_list_of_all_client_2025_02_17_12_10_38_28.xls</a> dated dated: 19th February 2025 20. Clinical Trials Insurance cover for study participants <a href="/attachments/download/1756">line_list_of_all_client_2025_02_17_12_10_38_27.xls</a> dated dated: 19th February 2025 21. Copy of favorable opinion letter from the local Ethics Review Committee (ERC). <a href="/attachments/download/1755">art_monthly_report_2025_02_18_07_55_57_10.xls</a> dated dated: 19th February 2025 22. Copy of current Practice Licenses for the Investigators and study Pharmacist <a href="/attachments/download/1754">line_list_of_all_client_2025_02_17_12_10_38_26.xls</a> dated dated: 19th February 2025 23. Copy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable <a href="/attachments/download/1753">art_monthly_report_2025_02_18_07_55_57_9.xls</a> dated dated: 19th February 2025 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/1743">art_monthly_report_2025_02_18_07_55_57_3.xls</a> dated dated: 19th February 2025 25. 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/1742">art_monthly_report_2025_02_18_07_55_57_2.xls</a> dated dated: 19th February 2025 26. Payment of fees <a href="/attachments/download/1741">line_list_of_all_client_2025_02_17_12_10_38_22.xls</a> dated dated: 19th February 2025 27. Statistical Analysis Plan <a href="/attachments/download/1740">line_list_of_all_client_2025_02_18_07_49_27_3.xls</a> dated 28. Signed Checklist <a href="/attachments/download/1739">line_list_of_all_client_2025_02_18_07_49_27_2.xls</a> dated dated: 19th February 2025 </div> After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials notes the following: Trial category workspace Amet illum labore Trial category comments Ab nisi omnis qui ea Trial phase workspace Consequatur repudian Trial phase comments (if in disagreement with the study phase proposed): Est in sed veritatis Therapeutic condition workspace Aut aperiam suscipit Brief description of the disease Reprehenderit delect 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 Est temporibus corr Assessor’s discussion on the clinical development: Molestiae minus sit Consider what is new in this trial, the clinical relevance, and the medical need that the trial aims to address Dignissimos amet ex Clinical Trial Rationale comments Quae voluptatum debi Consider if there are established primary endpoints for this type of study/indication, do they match the goals, are they validated? Fuga Alias ut volup Primary objectives comments Possimus explicabo Secondary objectives workspace Magni molestias omni Secondary objectives comments Mollitia officia sap Study population workspace Voluptatem excepteur Study population comments Eos in rerum nisi la Take also into consideration the gender and age allocation of participants, and determine whether a specific group is excluded or underrepresented Ex nostrum officia v Inclusion criteria comments Ab quas velit labori 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 Ut quisquam ea quaer Exclusion criteria comments Non quia debitis ape The inclusion of vulnerable population is justifiable only if this information cannot be obtained from nonâ€‘vulnerable populations For incapacitated or minor participants, the trial should offer some direct benefit to the tem or to the population that they represent Qui error amet cons Vulnerable populations comments Quis enim illum id 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 Pariatur Expedita n Study plan and design comments Quam odit est numqua Consider the dose(s)/dose steps, dose rationale, route of administration, schedule, treatment duration, and dose modifications Voluptatem Exceptur Study treatment comments Et sit omnis labore Comparator IMP(s) workspace Consequatur Eum mag Comparator IMP(s) comments Delectus debitis et Placebo workspace Repudiandae rem est Placebo comments Est laboriosam beat Auxilliary medicinal product(s) workspace Repudiandae nesciunt Auxilliary medicinal product(s) comments Vitae ea veniam nos Additional considerations workspace Aut sed officia ut d Additional considerations comments Elit distinctio Qu 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 Et distinctio Omnis Safety comments In omnis porro offic Blinding and unblinding workspace Eius corporis aliqua Blinding and unblinding comments Anim assumenda elit Contraception measures workspace Accusantium omnis en Contraception measures comments Sint Nam et enim qu Discontinuation criteria workspace Corrupti dolorem in Discontinuation criteria comments Laborum est iste cil Other concomitant workspace Vitae nostrud perfer Other concomitant comments Distinctio Facere i Safety and Monitoring workspace Sed veritatis autem Safety and Monitoring comments Sint dolor itaque v Reference Safety Information workspace Magnam aute a et imp Reference Safety Information comments Quibusdam et modi no Data Safety Monitoring Committee workspace Minim adipisicing an Data Safety Monitoring Committee comments Nulla culpa cum ex o Definition of the end of the trial workspace Cum est voluptatem e Definition of the end of the trial comments Consectetur accusan Biological samples used in the study workspace Sequi id itaque qui Biological samples used in the study comments Provident dolor et Data protection workspace Eaque expedita eos Data protection comments Voluptatem rerum bla Recruitment and informed consent procedures workspace Vero consequatur Oc Recruitment and informed consent procedures comment Obcaecati nisi neces Benefit/risk assessment workspace Recusandae Quidem s Comments on the benefit/risk: Sunt dolorem repreh Assessor’s overall conclusions workspace Ad laboris optio vo Overall comment/ conclusion on the clinical assessment: Dolor quia fugiat ev 1.5.1 REQUESTS FOR ADDITIONAL INFORMATION Voluptatem ut molest The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study: Test Input ECCT/25/02/06. 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 21st February 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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
 approvermanager
 approval_date21-02-2025
 expiry_date21-02-2026
 statusapproved
 deleted0
 deleted_date(null)
 created2025-02-21 12:12:06
 modified2025-02-21 12:20:23
 5(array)
 id85
 application_id196
 approval_noECCT/25/02/06/2025(56)
 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/25/02/06/2025(56) 28th March 2025 , Principal Investigator ECCT/25/02/06, Sit cupiditate similique iure aut, Dear Sir/Madam, Re: ECCT/25/02/06 : Initial Approval; Test Input Voluptatem Doloremque in amet. 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="http://45.79.161.190:8080/attachments/download/1737">line_list_of_all_client_2025_02_18_07_49_27.xls</a> dated: 19th February 2025 Version 1 2. The Study Protocol <a href="http://45.79.161.190:8080/attachments/download/1738">art_monthly_report_2025_02_18_07_55_57.xls</a> dated: 19th February 2025 3. 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/1744">art_monthly_report_2025_02_17_11_53_20_6.xls</a> dated: 19th February 2025 4. Patient Information leaflet and Informed consent form <a href="http://45.79.161.190:8080/attachments/download/1745">art_monthly_report_2025_02_18_07_55_57_4.xls</a> dated: 19th February 2025 5. Investigators Brochure/Package inserts <a href="http://45.79.161.190:8080/attachments/download/1746">line_list_of_all_client_2025_02_17_12_10_38_23.xls</a> dated: 19th February 2025 6. Investigational Medicinal Product Dossier (IMPD) <a href="http://45.79.161.190:8080/attachments/download/1747">art_monthly_report_2025_02_18_07_55_57_5.xls</a> dated: 19th February 2025 7. 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/1748">art_monthly_report_2025_02_18_07_55_57_6.xls</a> dated: 19th February 2025 8. Stability data of the investigational product <a href="http://45.79.161.190:8080/attachments/download/1749">line_list_of_all_client_2025_02_17_12_10_38_24.xls</a> dated: 19th February 2025 9. GMP certificate of the investigational product from the site of manufacture <a href="http://45.79.161.190:8080/attachments/download/1750">line_list_of_all_client_2025_02_17_12_10_38_25.xls</a> dated: 19th February 2025 10. Certificate of Analysis of the investigational product <a href="http://45.79.161.190:8080/attachments/download/1751">art_monthly_report_2025_02_18_07_55_57_7.xls</a> dated: 19th February 2025 Version 2 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/1752">art_monthly_report_2025_02_18_07_55_57_8.xls</a> dated: 19th February 2025 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/1764">art_monthly_report_2025_02_18_07_55_57_13.xls</a> dated: 19th February 2025 13. Evidence of contractual agreement between sponsor and Principal Investigator. <a href="http://45.79.161.190:8080/attachments/download/1763">line_list_of_all_client_2025_02_17_12_10_38_32.xls</a> dated: 19th February 2025 14. Evidence of recent GCP training of the core study staff <a href="http://45.79.161.190:8080/attachments/download/1762">art_monthly_report_2025_02_18_07_55_57_12.xls</a> dated: 19th February 2025 15. DSMB Charter including the composition and meeting schedule <a href="http://45.79.161.190:8080/attachments/download/1761">line_list_of_all_client_2025_02_17_12_10_38_31.xls</a> dated: 19th February 2025 16. Detailed budget of the study <a href="http://45.79.161.190:8080/attachments/download/1760">art_monthly_report_2025_02_18_07_55_57_11.xls</a> dated: 19th February 2025 17. Financial declaration by Sponsor and/or PI http://45.79.161.190:8080/admin/attachments/download/1736 <a href="http://45.79.161.190:8080/attachments/download/1759">line_list_of_all_client_2025_02_17_12_10_38_30.xls</a> dated: 19th February 2025 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. http://45.79.161.190:8080/admin/attachments/download/1732 <a href="http://45.79.161.190:8080/attachments/download/1758">line_list_of_all_client_2025_02_17_12_10_38_29.xls</a> dated: 19th February 2025 19. Indemnity cover for PI, investigators and study Pharmacist. <a href="http://45.79.161.190:8080/attachments/download/1757">line_list_of_all_client_2025_02_17_12_10_38_28.xls</a> dated: 19th February 2025 20. Clinical Trials Insurance cover for study participants <a href="http://45.79.161.190:8080/attachments/download/1756">line_list_of_all_client_2025_02_17_12_10_38_27.xls</a> dated: 19th February 2025 21. Copy of favorable opinion letter from the local Ethics Review Committee (ERC). <a href="http://45.79.161.190:8080/attachments/download/1755">art_monthly_report_2025_02_18_07_55_57_10.xls</a> dated: 19th February 2025 22. Copy of current Practice Licenses for the Investigators and study Pharmacist <a href="http://45.79.161.190:8080/attachments/download/1754">line_list_of_all_client_2025_02_17_12_10_38_26.xls</a> dated: 19th February 2025 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/1753">art_monthly_report_2025_02_18_07_55_57_9.xls</a> dated: 19th February 2025 24. For multicentre/multi-site studies, a site specific addendum for each of the proposed sites including among other things the sitesâ€™ capacity to carry out the study i.e personnel, equipment, laboratory etc <a href="http://45.79.161.190:8080/attachments/download/1743">art_monthly_report_2025_02_18_07_55_57_3.xls</a> dated: 19th February 2025 25. 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/1742">art_monthly_report_2025_02_18_07_55_57_2.xls</a> dated: 19th February 2025 26. Payment of fees <a href="http://45.79.161.190:8080/attachments/download/1741">line_list_of_all_client_2025_02_17_12_10_38_22.xls</a> dated: 19th February 2025 27. Statistical Analysis Plan <a href="http://45.79.161.190:8080/attachments/download/1740">line_list_of_all_client_2025_02_18_07_49_27_3.xls</a> 28. Signed Checklist <a href="http://45.79.161.190:8080/attachments/download/1739">line_list_of_all_client_2025_02_18_07_49_27_2.xls</a> dated: 19th February 2025 </div> After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials notes the following: Trial category workspace Amet illum labore Trial category comments Ab nisi omnis qui ea Trial phase workspace Consequatur repudian Trial phase comments (if in disagreement with the study phase proposed): Est in sed veritatis Therapeutic condition workspace Aut aperiam suscipit Brief description of the disease Reprehenderit delect 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 Est temporibus corr Assessorâ€™s discussion on the clinical development: Molestiae minus sit Consider what is new in this trial, the clinical relevance, and the medical need that the trial aims to address Dignissimos amet ex Clinical Trial Rationale comments Quae voluptatum debi Consider if there are established primary endpoints for this type of study/indication, do they match the goals, are they validated? Fuga Alias ut volup Primary objectives comments Possimus explicabo Secondary objectives workspace Magni molestias omni Secondary objectives comments Mollitia officia sap Study population workspace Voluptatem excepteur Study population comments Eos in rerum nisi la Take also into consideration the gender and age allocation of participants, and determine whether a specific group is excluded or underrepresented Ex nostrum officia v Inclusion criteria comments Ab quas velit labori 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 Ut quisquam ea quaer Exclusion criteria comments Non quia debitis ape The inclusion of vulnerable population is justifiable only if this information cannot be obtained from nonâ€‘vulnerable populations For incapacitated or minor participants, the trial should offer some direct benefit to the tem or to the population that they represent Qui error amet cons Vulnerable populations comments Quis enim illum id 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 Pariatur Expedita n Study plan and design comments Quam odit est numqua Consider the dose(s)/dose steps, dose rationale, route of administration, schedule, treatment duration, and dose modifications Voluptatem Exceptur Study treatment comments Et sit omnis labore Comparator IMP(s) workspace Consequatur Eum mag Comparator IMP(s) comments Delectus debitis et Placebo workspace Repudiandae rem est Placebo comments Est laboriosam beat Auxilliary medicinal product(s) workspace Repudiandae nesciunt Auxilliary medicinal product(s) comments Vitae ea veniam nos Additional considerations workspace Aut sed officia ut d Additional considerations comments Elit distinctio Qu 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 Et distinctio Omnis Safety comments In omnis porro offic Blinding and unblinding workspace Eius corporis aliqua Blinding and unblinding comments Anim assumenda elit Contraception measures workspace Accusantium omnis en Contraception measures comments Sint Nam et enim qu Discontinuation criteria workspace Corrupti dolorem in Discontinuation criteria comments Laborum est iste cil Other concomitant workspace Vitae nostrud perfer Other concomitant comments Distinctio Facere i Safety and Monitoring workspace Sed veritatis autem Safety and Monitoring comments Sint dolor itaque v Reference Safety Information workspace Magnam aute a et imp Reference Safety Information comments Quibusdam et modi no Data Safety Monitoring Committee workspace Minim adipisicing an Data Safety Monitoring Committee comments Nulla culpa cum ex o Definition of the end of the trial workspace Cum est voluptatem e Definition of the end of the trial comments Consectetur accusan Biological samples used in the study workspace Sequi id itaque qui Biological samples used in the study comments Provident dolor et Data protection workspace Eaque expedita eos Data protection comments Voluptatem rerum bla Recruitment and informed consent procedures workspace Vero consequatur Oc Recruitment and informed consent procedures comment Obcaecati nisi neces Benefit/risk assessment workspace Recusandae Quidem s Comments on the benefit/risk: Sunt dolorem repreh Assessorâ€™s overall conclusions workspace Ad laboris optio vo Overall comment/ conclusion on the clinical assessment: Dolor quia fugiat ev 1.5.1 REQUESTS FOR ADDITIONAL INFORMATION Voluptatem ut molest The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study: Test Input ECCT/25/02/06. 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 28th March 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 
 qrcode(null)
 approvermanager
 approval_date28-03-2025
 expiry_date28-03-2026
 statussubmitted
 deleted0
 deleted_date(null)
 created2025-03-28 11:41:36
 modified2025-03-28 11:41:36
 6(array)
 id86
 application_id196
 approval_noECCT/25/02/06/2025(57)
 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/25/02/06/2025(57) 28th March 2025 , Principal Investigator ECCT/25/02/06, Sit cupiditate similique iure aut, Dear Sir/Madam, Re: ECCT/25/02/06 : Initial Approval; Test Input Voluptatem Doloremque in amet. 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="http://45.79.161.190:8080/attachments/download/1737">line_list_of_all_client_2025_02_18_07_49_27.xls</a> dated: 19th February 2025 Version 1 2. The Study Protocol <a href="http://45.79.161.190:8080/attachments/download/1738">art_monthly_report_2025_02_18_07_55_57.xls</a> dated: 19th February 2025 3. 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/1744">art_monthly_report_2025_02_17_11_53_20_6.xls</a> dated: 19th February 2025 4. Patient Information leaflet and Informed consent form <a href="http://45.79.161.190:8080/attachments/download/1745">art_monthly_report_2025_02_18_07_55_57_4.xls</a> dated: 19th February 2025 5. Investigators Brochure/Package inserts <a href="http://45.79.161.190:8080/attachments/download/1746">line_list_of_all_client_2025_02_17_12_10_38_23.xls</a> dated: 19th February 2025 6. Investigational Medicinal Product Dossier (IMPD) <a href="http://45.79.161.190:8080/attachments/download/1747">art_monthly_report_2025_02_18_07_55_57_5.xls</a> dated: 19th February 2025 7. 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/1748">art_monthly_report_2025_02_18_07_55_57_6.xls</a> dated: 19th February 2025 8. Stability data of the investigational product <a href="http://45.79.161.190:8080/attachments/download/1749">line_list_of_all_client_2025_02_17_12_10_38_24.xls</a> dated: 19th February 2025 9. GMP certificate of the investigational product from the site of manufacture <a href="http://45.79.161.190:8080/attachments/download/1750">line_list_of_all_client_2025_02_17_12_10_38_25.xls</a> dated: 19th February 2025 10. Certificate of Analysis of the investigational product <a href="http://45.79.161.190:8080/attachments/download/1751">art_monthly_report_2025_02_18_07_55_57_7.xls</a> dated: 19th February 2025 Version 2 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/1752">art_monthly_report_2025_02_18_07_55_57_8.xls</a> dated: 19th February 2025 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/1764">art_monthly_report_2025_02_18_07_55_57_13.xls</a> dated: 19th February 2025 13. Evidence of contractual agreement between sponsor and Principal Investigator. <a href="http://45.79.161.190:8080/attachments/download/1763">line_list_of_all_client_2025_02_17_12_10_38_32.xls</a> dated: 19th February 2025 14. Evidence of recent GCP training of the core study staff <a href="http://45.79.161.190:8080/attachments/download/1762">art_monthly_report_2025_02_18_07_55_57_12.xls</a> dated: 19th February 2025 15. DSMB Charter including the composition and meeting schedule <a href="http://45.79.161.190:8080/attachments/download/1761">line_list_of_all_client_2025_02_17_12_10_38_31.xls</a> dated: 19th February 2025 16. Detailed budget of the study <a href="http://45.79.161.190:8080/attachments/download/1760">art_monthly_report_2025_02_18_07_55_57_11.xls</a> dated: 19th February 2025 17. Financial declaration by Sponsor and/or PI http://45.79.161.190:8080/admin/attachments/download/1736 <a href="http://45.79.161.190:8080/attachments/download/1759">line_list_of_all_client_2025_02_17_12_10_38_30.xls</a> dated: 19th February 2025 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. http://45.79.161.190:8080/admin/attachments/download/1732 <a href="http://45.79.161.190:8080/attachments/download/1758">line_list_of_all_client_2025_02_17_12_10_38_29.xls</a> dated: 19th February 2025 19. Indemnity cover for PI, investigators and study Pharmacist. <a href="http://45.79.161.190:8080/attachments/download/1757">line_list_of_all_client_2025_02_17_12_10_38_28.xls</a> dated: 19th February 2025 20. Clinical Trials Insurance cover for study participants <a href="http://45.79.161.190:8080/attachments/download/1756">line_list_of_all_client_2025_02_17_12_10_38_27.xls</a> dated: 19th February 2025 21. Copy of favorable opinion letter from the local Ethics Review Committee (ERC). <a href="http://45.79.161.190:8080/attachments/download/1755">art_monthly_report_2025_02_18_07_55_57_10.xls</a> dated: 19th February 2025 22. Copy of current Practice Licenses for the Investigators and study Pharmacist <a href="http://45.79.161.190:8080/attachments/download/1754">line_list_of_all_client_2025_02_17_12_10_38_26.xls</a> dated: 19th February 2025 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/1753">art_monthly_report_2025_02_18_07_55_57_9.xls</a> dated: 19th February 2025 24. For multicentre/multi-site studies, a site specific addendum for each of the proposed sites including among other things the sitesâ€™ capacity to carry out the study i.e personnel, equipment, laboratory etc <a href="http://45.79.161.190:8080/attachments/download/1743">art_monthly_report_2025_02_18_07_55_57_3.xls</a> dated: 19th February 2025 25. 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/1742">art_monthly_report_2025_02_18_07_55_57_2.xls</a> dated: 19th February 2025 26. Payment of fees <a href="http://45.79.161.190:8080/attachments/download/1741">line_list_of_all_client_2025_02_17_12_10_38_22.xls</a> dated: 19th February 2025 27. Statistical Analysis Plan <a href="http://45.79.161.190:8080/attachments/download/1740">line_list_of_all_client_2025_02_18_07_49_27_3.xls</a> 28. Signed Checklist <a href="http://45.79.161.190:8080/attachments/download/1739">line_list_of_all_client_2025_02_18_07_49_27_2.xls</a> dated: 19th February 2025 </div> After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials notes the following: Trial category workspace Amet illum labore Trial category comments Ab nisi omnis qui ea Trial phase workspace Consequatur repudian Trial phase comments (if in disagreement with the study phase proposed): Est in sed veritatis Therapeutic condition workspace Aut aperiam suscipit Brief description of the disease Reprehenderit delect 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 Est temporibus corr Assessorâ€™s discussion on the clinical development: Molestiae minus sit Consider what is new in this trial, the clinical relevance, and the medical need that the trial aims to address Dignissimos amet ex Clinical Trial Rationale comments Quae voluptatum debi Consider if there are established primary endpoints for this type of study/indication, do they match the goals, are they validated? Fuga Alias ut volup Primary objectives comments Possimus explicabo Secondary objectives workspace Magni molestias omni Secondary objectives comments Mollitia officia sap Study population workspace Voluptatem excepteur Study population comments Eos in rerum nisi la Take also into consideration the gender and age allocation of participants, and determine whether a specific group is excluded or underrepresented Ex nostrum officia v Inclusion criteria comments Ab quas velit labori 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 Ut quisquam ea quaer Exclusion criteria comments Non quia debitis ape The inclusion of vulnerable population is justifiable only if this information cannot be obtained from nonâ€‘vulnerable populations For incapacitated or minor participants, the trial should offer some direct benefit to the tem or to the population that they represent Qui error amet cons Vulnerable populations comments Quis enim illum id 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 Pariatur Expedita n Study plan and design comments Quam odit est numqua Consider the dose(s)/dose steps, dose rationale, route of administration, schedule, treatment duration, and dose modifications Voluptatem Exceptur Study treatment comments Et sit omnis labore Comparator IMP(s) workspace Consequatur Eum mag Comparator IMP(s) comments Delectus debitis et Placebo workspace Repudiandae rem est Placebo comments Est laboriosam beat Auxilliary medicinal product(s) workspace Repudiandae nesciunt Auxilliary medicinal product(s) comments Vitae ea veniam nos Additional considerations workspace Aut sed officia ut d Additional considerations comments Elit distinctio Qu 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 Et distinctio Omnis Safety comments In omnis porro offic Blinding and unblinding workspace Eius corporis aliqua Blinding and unblinding comments Anim assumenda elit Contraception measures workspace Accusantium omnis en Contraception measures comments Sint Nam et enim qu Discontinuation criteria workspace Corrupti dolorem in Discontinuation criteria comments Laborum est iste cil Other concomitant workspace Vitae nostrud perfer Other concomitant comments Distinctio Facere i Safety and Monitoring workspace Sed veritatis autem Safety and Monitoring comments Sint dolor itaque v Reference Safety Information workspace Magnam aute a et imp Reference Safety Information comments Quibusdam et modi no Data Safety Monitoring Committee workspace Minim adipisicing an Data Safety Monitoring Committee comments Nulla culpa cum ex o Definition of the end of the trial workspace Cum est voluptatem e Definition of the end of the trial comments Consectetur accusan Biological samples used in the study workspace Sequi id itaque qui Biological samples used in the study comments Provident dolor et Data protection workspace Eaque expedita eos Data protection comments Voluptatem rerum bla Recruitment and informed consent procedures workspace Vero consequatur Oc Recruitment and informed consent procedures comment Obcaecati nisi neces Benefit/risk assessment workspace Recusandae Quidem s Comments on the benefit/risk: Sunt dolorem repreh Assessorâ€™s overall conclusions workspace Ad laboris optio vo Overall comment/ conclusion on the clinical assessment: Dolor quia fugiat ev 1.5.1 REQUESTS FOR ADDITIONAL INFORMATION Voluptatem ut molest The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study: Test Input ECCT/25/02/06. 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 28th March 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 
 qrcode(null)
 approvermanager
 approval_date28-03-2025
 expiry_date28-03-2026
 statussubmitted
 deleted0
 deleted_date(null)
 created2025-03-28 11:42:44
 modified2025-03-28 11:42:44
 AmendmentLetter(empty)
 AmendmentApproval(empty)
 AmendmentApprovalSummary(empty)
 Organization(array)
 0(array)
 id48
 application_id196
 organization
 contact_person
 address
 telephone_number
 all_tasks
 monitoring
 regulatory
 investigator_recruitment
 ivrs_treatment_randomisation
 data_management
 e_data_capture
 susar_reporting
 quality_assurance_auditing
 statistical_analysis
 medical_writing
 other_duties
 other_duties_specify
 misc(null)
 created2025-02-19 08:52:20
 modified2025-02-19 09:13:23
 SiteDetail(array)
 0(array)
 id1750
 application_id196
 county_id2
 site_nameShannon Grant
 physical_addressEarum dolore id necessitatibus dignissimos vitae quas eos nihil odit aut inventore vel facere consequatur
 contact_detailsPO Box 48
 contact_personPariatur Eos in quisquam exercitation
 site_capacity(null)
 misc(null)
 created2025-02-19 08:52:20
 modified2025-02-19 09:13:23
 Placebo(array)
 0(array)
 id48
 application_id196
 placebo_present(null)
 pharmaceutical_formRecusandae Qui ullamco totam magnam lorem placeat eveniet officia sit quidem ut
 route_of_administrationVoluptas incididunt facilis numquam officia placeat consequuntur id non
 compositionMinim irure aut quibusdam cillum natus beatae sit aliquam dolores voluptatem ut culpa
 identical_indpNo
 major_ingredientsRepellendus Et dict
 created2025-02-19 08:52:20
 modified2025-02-19 09:13:23
 Sponsor(array)
 0(array)
 id48
 application_id196
 sponsorIncidunt quam eligendi commodi alias possimus fugiat ullam animi suscipit veritatis perspiciatis ad enim ut minima
 sponsor_typeResearch Institution
 contact_personOfficia sunt ut ea et ex in consequatur quia et
 addressIllum ipsa ea nisi qui atque repellendus
 telephone_number+11938667688
 fax_number+19741752234
 cell_number+18795671669
 email_addresszifiqi@mailinator.com
 created2025-02-19 08:52:20
 modified2025-02-19 09:13:23
 SiteInspection(empty)
 Sae(array)
 0(array)
 id31
 application_id196
 sae_id(null)
 reference_noSUSAR/2025/01
 form_typeSUSAR
 user_id91
 patient_initials(null)
 country_id(null)
 date_of_birth(null)
 age_years(null)
 gender(null)
 causality(null)
 enrollment_date(null)
 administration_date(null)
 latest_date(null)
 reaction_onset(null)
 reaction_end_date(null)
 patient_died0
 prolonged_hospitalization0
 incapacity0
 life_threatening0
 reaction_other0
 reaction_description(null)
 relevant_history(null)
 manufacturer_name(null)
 mfr_no(null)
 manufacturer_date(null)
 source_study0
 source_literature0
 source_health_professional0
 report_date(null)
 report_typeInitial
 approved0
 date_submitted(null)
 approved_by(null)
 email_addressbmuyundo@intellisoftkenya.com
 reporter_name(null)
 reporter_phone(null)
 reporter_emailbmuyundo@intellisoftkenya.com
 deleted0
 deleted_date(null)
 created2025-03-04 14:37:15
 modified2025-03-04 14:37:15
 Ciom(empty)
 StudyRoute(array)
 0(array)
 id534
 application_id196
 study_routeintra corpus cavernosum
 created2025-02-19 08:52:20
 modified2025-02-19 09:13:23
 Manufacturer(array)
 0(array)
 id48
 application_id196
 manufacturer_nameStephen Potts
 addressBlanditiis laborum Vero minima aliquip magnam voluptatibus do adipisci consectetur ut iure hic itaque corrupti aut laboriosam molestias
 manufacturer_countryKyrgyzstan
 manufacturer_phone+11956324803
 manufacturer_emailhefumeqyc@mailinator.com
 manufacturing_activitiesPartial manufacturing
 other_specifyCorrupti facilis vero voluptate deserunt repudiandae atque aute at inventore distinctio Voluptas pariatur At commodo nihil in incididunt commodo
 created2025-02-19 08:52:20
 modified2025-02-19 09:13:23
 Reassignment(empty)
 Attachment(empty)
 AnnualApproval(empty)
 AmendmentChecklist(empty)
 Reminder(empty)
 ParticipantFlow(empty)
 Budget(array)
 0(array)
 id48
 application_id196
 year(null)
 budget_period(null)
 personnel_currencyKES
 personnel1000
 transport_currencyKES
 transport0
 field_currencyKES
 field30000
 supplies_currencyKES
 supplies
 pharmacy_currencyKES
 pharmacy
 travel_currencyKES
 travel
 regulatory_currencyKES
 regulatory
 it_currencyKES
 it
 lab_currency(null)
 lab(null)
 others_currencyKES
 others
 kemri_currency(null)
 kemri(null)
 wrair_currency(null)
 wrair(null)
 subject_currencyKES
 subject1627
 grand_currencyKES
 grand_total
 study_information
 personnel_kshs
 transport_kshs
 field_kshs
 supplies_kshs
 pharmacy_kshs
 travel_kshs
 regulatory_kshs
 it_kshs
 lab_kshs(null)
 others_kshs
 grand_total_kshs
 subject_kshs
 created2025-02-19 08:52:20
 modified2025-02-19 09:13:23
 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(array)
 0(array)
 id1737
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/gen/line_list_of_all_client_2025_02_18_07_49_27.xls
 foreign_key196
 dirnamegen
 basenameline_list_of_all_client_2025_02_18_07_49_27.xls
 checksum7b6387a6a5c80a383b7abe8b7c1e0257
 alternative(null)
 groupapplicant_covering_letter
 descriptionCover Letter (Should list all the submitted documents, their version numbers and dates) *
 year(null)
 file_date19-02-2025
 pocket_nameapplicant_covering_letter
 version_no1
 created2025-02-19 09:03:51
 modified2025-02-19 09:13:23
 pathgen/line_list_of_all_client_2025_02_18_07_49_27.xls
 1(array)
 id1738
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/gen/art_monthly_report_2025_02_18_07_55_57.xls
 foreign_key196
 dirnamegen
 basenameart_monthly_report_2025_02_18_07_55_57.xls
 checksumf867f664a6f087549c8008b577a9a37f
 alternative(null)
 groupapplicant_protocol
 descriptionThe Study Protocol *
 year(null)
 file_date19-02-2025
 pocket_nameapplicant_protocol
 version_no
 created2025-02-19 09:04:14
 modified2025-02-19 09:04:14
 pathgen/art_monthly_report_2025_02_18_07_55_57.xls
 2(array)
 id1739
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/gen/line_list_of_all_client_2025_02_18_07_49_27_2.xls
 foreign_key196
 dirnamegen
 basenameline_list_of_all_client_2025_02_18_07_49_27_2.xls
 checksum7b6387a6a5c80a383b7abe8b7c1e0257
 alternative(null)
 groupapplicant_signed_checklist
 descriptionSigned Checklist *
 year(null)
 file_date19-02-2025
 pocket_nameapplicant_signed_checklist
 version_no
 created2025-02-19 09:04:37
 modified2025-02-19 09:11:39
 pathgen/line_list_of_all_client_2025_02_18_07_49_27_2.xls
 3(array)
 id1740
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/gen/line_list_of_all_client_2025_02_18_07_49_27_3.xls
 foreign_key196
 dirnamegen
 basenameline_list_of_all_client_2025_02_18_07_49_27_3.xls
 checksum7b6387a6a5c80a383b7abe8b7c1e0257
 alternative(null)
 groupstatistical_analysis_plan
 descriptionStatistical Analysis Plan *
 year(null)
 file_date(null)
 pocket_namestatistical_analysis_plan
 version_no
 created2025-02-19 09:04:47
 modified2025-02-19 09:04:47
 pathgen/line_list_of_all_client_2025_02_18_07_49_27_3.xls
 4(array)
 id1741
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/gen/line_list_of_all_client_2025_02_17_12_10_38_22.xls
 foreign_key196
 dirnamegen
 basenameline_list_of_all_client_2025_02_17_12_10_38_22.xls
 checksum933de56eb3c8ac93c17adc50d4be6375
 alternative(null)
 groupapplicant_fees
 descriptionPayment of fees *
 year(null)
 file_date19-02-2025
 pocket_nameapplicant_fees
 version_no
 created2025-02-19 09:05:11
 modified2025-02-19 09:05:11
 pathgen/line_list_of_all_client_2025_02_17_12_10_38_22.xls
 5(array)
 id1742
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/gen/art_monthly_report_2025_02_18_07_55_57_2.xls
 foreign_key196
 dirnamegen
 basenameart_monthly_report_2025_02_18_07_55_57_2.xls
 checksumf867f664a6f087549c8008b577a9a37f
 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_date19-02-2025
 pocket_nameapplicant_statement
 version_no
 created2025-02-19 09:05:24
 modified2025-02-19 09:05:24
 pathgen/art_monthly_report_2025_02_18_07_55_57_2.xls
 6(array)
 id1743
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/gen/art_monthly_report_2025_02_18_07_55_57_3.xls
 foreign_key196
 dirnamegen
 basenameart_monthly_report_2025_02_18_07_55_57_3.xls
 checksumf867f664a6f087549c8008b577a9a37f
 alternative(null)
 groupapplicant_addendum
 descriptionFor multicentre/multi-site studies, a site specific addendum for each of the proposed sites including among other things the sitesâ€™ capacity to carry out the study i.e personnel, equipment, laboratory etc
 year(null)
 file_date19-02-2025
 pocket_nameapplicant_addendum
 version_no
 created2025-02-19 09:05:38
 modified2025-02-19 09:05:38
 pathgen/art_monthly_report_2025_02_18_07_55_57_3.xls
 7(array)
 id1744
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/gen/art_monthly_report_2025_02_17_11_53_20_6.xls
 foreign_key196
 dirnamegen
 basenameart_monthly_report_2025_02_17_11_53_20_6.xls
 checksum240e60b5bf9eb0dc85a3d5df4ad0450c
 alternative(null)
 groupapplicant_pan_african
 descriptionRegistration of the study at Pan African Clinical Trials Registry https://pactr.samrc.ac.za *
 year(null)
 file_date19-02-2025
 pocket_nameapplicant_pan_african
 version_no
 created2025-02-19 09:06:05
 modified2025-02-19 09:06:05
 pathgen/art_monthly_report_2025_02_17_11_53_20_6.xls
 8(array)
 id1745
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/gen/art_monthly_report_2025_02_18_07_55_57_4.xls
 foreign_key196
 dirnamegen
 basenameart_monthly_report_2025_02_18_07_55_57_4.xls
 checksumf867f664a6f087549c8008b577a9a37f
 alternative(null)
 groupapplicant_patient_information
 descriptionPatient Information leaflet and Informed consent form *
 year(null)
 file_date19-02-2025
 pocket_nameapplicant_patient_information
 version_no
 created2025-02-19 09:06:26
 modified2025-02-19 09:06:26
 pathgen/art_monthly_report_2025_02_18_07_55_57_4.xls
 9(array)
 id1746
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/gen/line_list_of_all_client_2025_02_17_12_10_38_23.xls
 foreign_key196
 dirnamegen
 basenameline_list_of_all_client_2025_02_17_12_10_38_23.xls
 checksum933de56eb3c8ac93c17adc50d4be6375
 alternative(null)
 groupapplicant_investigators_brochure
 descriptionInvestigators Brochure/Package inserts *
 year(null)
 file_date19-02-2025
 pocket_nameapplicant_investigators_brochure
 version_no
 created2025-02-19 09:06:47
 modified2025-02-19 09:06:47
 pathgen/line_list_of_all_client_2025_02_17_12_10_38_23.xls
 10(array)
 id1747
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/gen/art_monthly_report_2025_02_18_07_55_57_5.xls
 foreign_key196
 dirnamegen
 basenameart_monthly_report_2025_02_18_07_55_57_5.xls
 checksumf867f664a6f087549c8008b577a9a37f
 alternative(null)
 groupapplicant_impd
 descriptionInvestigational Medicinal Product Dossier (IMPD) *
 year(null)
 file_date19-02-2025
 pocket_nameapplicant_impd
 version_no
 created2025-02-19 09:07:07
 modified2025-02-19 09:07:07
 pathgen/art_monthly_report_2025_02_18_07_55_57_5.xls
 11(array)
 id1748
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/gen/art_monthly_report_2025_02_18_07_55_57_6.xls
 foreign_key196
 dirnamegen
 basenameart_monthly_report_2025_02_18_07_55_57_6.xls
 checksumf867f664a6f087549c8008b577a9a37f
 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_date19-02-2025
 pocket_nameapplicant_prev_data
 version_no
 created2025-02-19 09:07:21
 modified2025-02-19 09:07:21
 pathgen/art_monthly_report_2025_02_18_07_55_57_6.xls
 12(array)
 id1749
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/gen/line_list_of_all_client_2025_02_17_12_10_38_24.xls
 foreign_key196
 dirnamegen
 basenameline_list_of_all_client_2025_02_17_12_10_38_24.xls
 checksum933de56eb3c8ac93c17adc50d4be6375
 alternative(null)
 groupapplicant_stability_data
 descriptionStability data of the investigational product *
 year(null)
 file_date19-02-2025
 pocket_nameapplicant_stability_data
 version_no
 created2025-02-19 09:07:46
 modified2025-02-19 09:07:46
 pathgen/line_list_of_all_client_2025_02_17_12_10_38_24.xls
 13(array)
 id1750
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/gen/line_list_of_all_client_2025_02_17_12_10_38_25.xls
 foreign_key196
 dirnamegen
 basenameline_list_of_all_client_2025_02_17_12_10_38_25.xls
 checksum933de56eb3c8ac93c17adc50d4be6375
 alternative(null)
 groupapplicant_gmp_certificate
 descriptionGMP certificate of the investigational product from the site of manufacture *
 year(null)
 file_date19-02-2025
 pocket_nameapplicant_gmp_certificate
 version_no
 created2025-02-19 09:07:55
 modified2025-02-19 09:07:55
 pathgen/line_list_of_all_client_2025_02_17_12_10_38_25.xls
 14(array)
 id1751
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/gen/art_monthly_report_2025_02_18_07_55_57_7.xls
 foreign_key196
 dirnamegen
 basenameart_monthly_report_2025_02_18_07_55_57_7.xls
 checksumf867f664a6f087549c8008b577a9a37f
 alternative(null)
 groupapplicant_analysis_cert
 descriptionCertificate of Analysis of the investigational product *
 year(null)
 file_date19-02-2025
 pocket_nameapplicant_analysis_cert
 version_no2
 created2025-02-19 09:08:09
 modified2025-02-19 09:08:09
 pathgen/art_monthly_report_2025_02_18_07_55_57_7.xls
 15(array)
 id1752
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/gen/art_monthly_report_2025_02_18_07_55_57_8.xls
 foreign_key196
 dirnamegen
 basenameart_monthly_report_2025_02_18_07_55_57_8.xls
 checksumf867f664a6f087549c8008b577a9a37f
 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_date19-02-2025
 pocket_nameapplicant_pictorial_sample
 version_no
 created2025-02-19 09:08:27
 modified2025-02-19 09:08:27
 pathgen/art_monthly_report_2025_02_18_07_55_57_8.xls
 16(array)
 id1753
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/gen/art_monthly_report_2025_02_18_07_55_57_9.xls
 foreign_key196
 dirnamegen
 basenameart_monthly_report_2025_02_18_07_55_57_9.xls
 checksumf867f664a6f087549c8008b577a9a37f
 alternative(null)
 groupapplicant_approval_letter
 descriptionCopy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable *
 year(null)
 file_date19-02-2025
 pocket_nameapplicant_approval_letter
 version_no
 created2025-02-19 09:08:41
 modified2025-02-19 09:08:41
 pathgen/art_monthly_report_2025_02_18_07_55_57_9.xls
 17(array)
 id1754
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/gen/line_list_of_all_client_2025_02_17_12_10_38_26.xls
 foreign_key196
 dirnamegen
 basenameline_list_of_all_client_2025_02_17_12_10_38_26.xls
 checksum933de56eb3c8ac93c17adc50d4be6375
 alternative(null)
 groupapplicant_practice_license
 descriptionCopy of current Practice Licenses for the Investigators and study Pharmacist *
 year(null)
 file_date19-02-2025
 pocket_nameapplicant_practice_license
 version_no
 created2025-02-19 09:08:51
 modified2025-02-19 09:08:51
 pathgen/line_list_of_all_client_2025_02_17_12_10_38_26.xls
 18(array)
 id1755
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/gen/art_monthly_report_2025_02_18_07_55_57_10.xls
 foreign_key196
 dirnamegen
 basenameart_monthly_report_2025_02_18_07_55_57_10.xls
 checksumf867f664a6f087549c8008b577a9a37f
 alternative(null)
 groupapplicant_opinion_letter
 descriptionCopy of favorable opinion letter from the local Ethics Review Committee (ERC). *
 year(null)
 file_date19-02-2025
 pocket_nameapplicant_opinion_letter
 version_no
 created2025-02-19 09:09:06
 modified2025-02-19 09:09:06
 pathgen/art_monthly_report_2025_02_18_07_55_57_10.xls
 19(array)
 id1756
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/gen/line_list_of_all_client_2025_02_17_12_10_38_27.xls
 foreign_key196
 dirnamegen
 basenameline_list_of_all_client_2025_02_17_12_10_38_27.xls
 checksum933de56eb3c8ac93c17adc50d4be6375
 alternative(null)
 groupapplicant_indemnity_cover
 descriptionClinical Trials Insurance cover for study participants *
 year(null)
 file_date19-02-2025
 pocket_nameapplicant_indemnity_cover
 version_no
 created2025-02-19 09:09:17
 modified2025-02-19 09:09:17
 pathgen/line_list_of_all_client_2025_02_17_12_10_38_27.xls
 20(array)
 id1757
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/gen/line_list_of_all_client_2025_02_17_12_10_38_28.xls
 foreign_key196
 dirnamegen
 basenameline_list_of_all_client_2025_02_17_12_10_38_28.xls
 checksum933de56eb3c8ac93c17adc50d4be6375
 alternative(null)
 groupapplicant_indemnity_pi
 descriptionIndemnity cover for PI, investigators and study Pharmacist. *
 year(null)
 file_date19-02-2025
 pocket_nameapplicant_indemnity_pi
 version_no
 created2025-02-19 09:09:31
 modified2025-02-19 09:09:31
 pathgen/line_list_of_all_client_2025_02_17_12_10_38_28.xls
 21(array)
 id1758
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/gen/line_list_of_all_client_2025_02_17_12_10_38_29.xls
 foreign_key196
 dirnamegen
 basenameline_list_of_all_client_2025_02_17_12_10_38_29.xls
 checksum933de56eb3c8ac93c17adc50d4be6375
 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. http://45.79.161.190:8080/admin/attachments/download/1732 *
 year(null)
 file_date19-02-2025
 pocket_nameapplicant_signed_declaration
 version_no
 created2025-02-19 09:09:47
 modified2025-02-19 09:09:47
 pathgen/line_list_of_all_client_2025_02_17_12_10_38_29.xls
 22(array)
 id1759
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/gen/line_list_of_all_client_2025_02_17_12_10_38_30.xls
 foreign_key196
 dirnamegen
 basenameline_list_of_all_client_2025_02_17_12_10_38_30.xls
 checksum933de56eb3c8ac93c17adc50d4be6375
 alternative(null)
 groupapplicant_financial_declaration
 descriptionFinancial declaration by Sponsor and/or PI http://45.79.161.190:8080/admin/attachments/download/1736 *
 year(null)
 file_date19-02-2025
 pocket_nameapplicant_financial_declaration
 version_no
 created2025-02-19 09:10:24
 modified2025-02-19 09:10:24
 pathgen/line_list_of_all_client_2025_02_17_12_10_38_30.xls
 23(array)
 id1760
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/gen/art_monthly_report_2025_02_18_07_55_57_11.xls
 foreign_key196
 dirnamegen
 basenameart_monthly_report_2025_02_18_07_55_57_11.xls
 checksumf867f664a6f087549c8008b577a9a37f
 alternative(null)
 groupapplicant_detailed_budget
 descriptionDetailed budget of the study *
 year(null)
 file_date19-02-2025
 pocket_nameapplicant_detailed_budget
 version_no
 created2025-02-19 09:10:35
 modified2025-02-19 09:10:35
 pathgen/art_monthly_report_2025_02_18_07_55_57_11.xls
 24(array)
 id1761
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/gen/line_list_of_all_client_2025_02_17_12_10_38_31.xls
 foreign_key196
 dirnamegen
 basenameline_list_of_all_client_2025_02_17_12_10_38_31.xls
 checksum933de56eb3c8ac93c17adc50d4be6375
 alternative(null)
 groupapplicant_dsmb_charter
 descriptionDSMB Charter including the composition and meeting schedule *
 year(null)
 file_date19-02-2025
 pocket_nameapplicant_dsmb_charter
 version_no
 created2025-02-19 09:10:48
 modified2025-02-19 09:10:48
 pathgen/line_list_of_all_client_2025_02_17_12_10_38_31.xls
 25(array)
 id1762
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/gen/art_monthly_report_2025_02_18_07_55_57_12.xls
 foreign_key196
 dirnamegen
 basenameart_monthly_report_2025_02_18_07_55_57_12.xls
 checksumf867f664a6f087549c8008b577a9a37f
 alternative(null)
 groupapplicant_gcp_training
 descriptionEvidence of recent GCP training of the core study staff *
 year(null)
 file_date19-02-2025
 pocket_nameapplicant_gcp_training
 version_no
 created2025-02-19 09:11:10
 modified2025-02-19 09:11:10
 pathgen/art_monthly_report_2025_02_18_07_55_57_12.xls
 26(array)
 id1763
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/gen/line_list_of_all_client_2025_02_17_12_10_38_32.xls
 foreign_key196
 dirnamegen
 basenameline_list_of_all_client_2025_02_17_12_10_38_32.xls
 checksum933de56eb3c8ac93c17adc50d4be6375
 alternative(null)
 groupapplicant_contractual_agreement
 descriptionEvidence of contractual agreement between sponsor and Principal Investigator. *
 year(null)
 file_date19-02-2025
 pocket_nameapplicant_contractual_agreement
 version_no
 created2025-02-19 09:11:22
 modified2025-02-19 09:11:22
 pathgen/line_list_of_all_client_2025_02_17_12_10_38_32.xls
 27(array)
 id1764
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/gen/art_monthly_report_2025_02_18_07_55_57_13.xls
 foreign_key196
 dirnamegen
 basenameart_monthly_report_2025_02_18_07_55_57_13.xls
 checksumf867f664a6f087549c8008b577a9a37f
 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_date19-02-2025
 pocket_nameapplicant_investigators_cv
 version_no
 created2025-02-19 09:11:37
 modified2025-02-19 09:11:37
 pathgen/art_monthly_report_2025_02_18_07_55_57_13.xls
 StudyMonitor(empty)
 ProtocolOutsource(empty)
 Outsource(array)
 0(array)
 id8
 application_id196
 user_id(null)
 model
 usernamejayoma
 namejayoma
 emailjayoma@intellisoftkenya.com
 phone_no+254702674563
 institution_physical
 name_of_institution
 institution_address
 institution_contact
 county_id(null)
 country_id115
 approved0
 created2025-02-19 09:45:11
 modified2025-02-19 09:45:11
 accepted(null)
 model_sae1
 model_ciom0
 model_dev0
- redir
- $request->data(empty)
- $this->validationErrors(array)
 Permission(empty)
 Aro(empty)
 Aco(empty)
 Application(empty)
 User(empty)
 TrialStatus(empty)
 Review(empty)
 InternalReview(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/196'
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=leso7f8as5spkqcnkje00lak50'
Http Accept Encoding	'gzip, br, zstd, deflate'
Http Host	'45.79.161.190:8080'
Http Via	'1.1 squid-proxy-5b96dc6d46-nrc5k (squid/6.13)'
Http X Forwarded For	'10.9.62.171'
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/2.4.41 (Ubuntu) Server at 45.79.161.190 Port 8080 '
Server Software	'Apache/2.4.41 (Ubuntu)'
Server Name	'45.79.161.190'
Server Addr	'45.79.161.190'
Server Port	'8080'
Remote Addr	'216.73.216.79'
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	'65204'
Redirect Url	'/app/webroot/applications/view/196'
Gateway Interface	'CGI/1.1'
Server Protocol	'HTTP/1.1'
Request Method	'GET'
Query String	''
Request Uri	'/applications/view/196'
Script Name	'/app/webroot/index.php'
Php Self	'/app/webroot/index.php'
Request Time Float	(float) 1786975782.749
Request Time	(int) 1786975782

====

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:	Test Input
Study Objectives:	test
Laymans Summary:	Test Input
Abstract of Study:	Test 2

Test Input

Request History

Session

Request

Cake Params

Post data

Query string

Cookie

Current Route

Sql Logs

default

Total Time: 81 ms Total Queries: 54 queries

Query Explain:

Memory

Timers

Logs

View Variables

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

Included Files

Total Time: 81 ms
Total Queries: 54 queries