Pharmacy and Poisons Board: Applications

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- controllerapplications
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- pass(array)
  0124
- isAjax(false)
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====

Sql Logs

default

Total Time: 59 ms
Total Queries: 53 queries

Query	Affected	Num. rows	Took (ms)	Actions
SELECT COUNT(*) AS `count` FROM `ctr`.`applications` AS `Application` WHERE `Application`.`id` = 124	1	1	0
SELECT `Application`.`id`, `Application`.`user_id`, `Application`.`application_id`, `Application`.`is_child`, `Application`.`trial_status_id`, `Application`.`total_sites`, `Application`.`abstract_of_study`, `Application`.`study_title`, `Application`.`laymans_summary`, `Application`.`short_title`, `Application`.`protocol_no`, `Application`.`reference_no`, `Application`.`version_no`, `Application`.`date_of_protocol`, `Application`.`study_drug`, `Application`.`disease_condition`, `Application`.`product_type_biologicals`, `Application`.`product_type_proteins`, `Application`.`product_type_immunologicals`, `Application`.`product_type_vaccines`, `Application`.`product_type_hormones`, `Application`.`product_type_toxoid`, `Application`.`product_type_chemical`, `Application`.`product_type_medical_device`, `Application`.`product_type_chemical_name`, `Application`.`product_type_medical_device_name`, `Application`.`comparator`, `Application`.`comparator_name`, `Application`.`comparator_registered`, `Application`.`comparator_countries`, `Application`.`ecct_not_applicable`, `Application`.`ecct_ref_number`, `Application`.`email_address`, `Application`.`applicant_covering_letter`, `Application`.`applicant_protocol`, `Application`.`applicant_patient_information`, `Application`.`applicant_investigators_brochure`, `Application`.`applicant_investigators_cv`, `Application`.`applicant_signed_declaration`, `Application`.`applicant_financial_declaration`, `Application`.`applicant_gmp_certificate`, `Application`.`applicant_indemnity_cover`, `Application`.`applicant_opinion_letter`, `Application`.`applicant_approval_letter`, `Application`.`applicant_statement`, `Application`.`applicant_participating_countries`, `Application`.`applicant_addendum`, `Application`.`applicant_fees`, `Application`.`applicant_complete_form`, `Application`.`applicant_impd`, `Application`.`applicant_prev_data`, `Application`.`applicant_stability_data`, `Application`.`applicant_analysis_cert`, `Application`.`applicant_pictorial_sample`, `Application`.`applicant_gcp_training`, `Application`.`applicant_dsmb_charter`, `Application`.`applicant_detailed_budget`, `Application`.`applicant_indemnity_pi`, `Application`.`applicant_practice_license`, `Application`.`applicant_registration_ctr`, `Application`.`applicant_pan_african`, `Application`.`applicant_hard_copies`, `Application`.`applicant_signed_checklist`, `Application`.`statistical_analysis_plan`, `Application`.`applicant_contractual_agreement`, `Application`.`declaration_applicant`, `Application`.`declaration_date1`, `Application`.`declaration_principal_investigator`, `Application`.`declaration_date2`, `Application`.`placebo_present`, `Application`.`study_objectives`, `Application`.`principal_inclusion_criteria`, `Application`.`principal_exclusion_criteria`, `Application`.`primary_end_points`, `Application`.`scope_diagnosis`, `Application`.`scope_prophylaxis`, `Application`.`scope_therapy`, `Application`.`scope_safety`, `Application`.`scope_efficacy`, `Application`.`scope_pharmacokinetic`, `Application`.`scope_pharmacodynamic`, `Application`.`scope_bioequivalence`, `Application`.`scope_dose_response`, `Application`.`scope_pharmacogenetic`, `Application`.`scope_pharmacogenomic`, `Application`.`scope_pharmacoecomomic`, `Application`.`scope_others`, `Application`.`scope_others_specify`, `Application`.`trial_human_pharmacology`, `Application`.`trial_administration_humans`, `Application`.`trial_bioequivalence_study`, `Application`.`trial_other`, `Application`.`trial_other_specify`, `Application`.`trial_therapeutic_exploratory`, `Application`.`trial_therapeutic_confirmatory`, `Application`.`trial_therapeutic_use`, `Application`.`design_controlled`, `Application`.`site_capacity`, `Application`.`staff_numbers`, `Application`.`other_details_explanation`, `Application`.`other_details_regulatory_notapproved`, `Application`.`other_details_regulatory_approved`, `Application`.`other_details_regulatory_rejected`, `Application`.`other_details_regulatory_halted`, `Application`.`estimated_duration`, `Application`.`design_controlled_randomised`, `Application`.`design_controlled_open`, `Application`.`design_controlled_single_blind`, `Application`.`design_controlled_double_blind`, `Application`.`design_controlled_parallel_group`, `Application`.`design_controlled_cross_over`, `Application`.`design_controlled_other`, `Application`.`design_controlled_specify`, `Application`.`design_controlled_comparator`, `Application`.`design_controlled_other_medicinal`, `Application`.`design_controlled_placebo`, `Application`.`design_controlled_medicinal_other`, `Application`.`design_controlled_medicinal_specify`, `Application`.`single_site_member_state`, `Application`.`location_of_area`, `Application`.`single_site_physical_address`, `Application`.`single_site_contact_person`, `Application`.`single_site_telephone`, `Application`.`multiple_sites_member_state`, `Application`.`multiple_countries`, `Application`.`multiple_member_states`, `Application`.`number_of_sites`, `Application`.`multi_country_list`, `Application`.`data_monitoring_committee`, `Application`.`total_enrolment_per_site`, `Application`.`total_participants_worldwide`, `Application`.`population_less_than_18_years`, `Application`.`population_utero`, `Application`.`population_preterm_newborn`, `Application`.`population_newborn`, `Application`.`population_infant_and_toddler`, `Application`.`population_children`, `Application`.`population_adolescent`, `Application`.`population_above_18`, `Application`.`population_adult`, `Application`.`population_elderly`, `Application`.`gender_female`, `Application`.`gender_male`, `Application`.`subjects_healthy`, `Application`.`subjects_patients`, `Application`.`subjects_vulnerable_populations`, `Application`.`subjects_women_child_bearing`, `Application`.`subjects_women_using_contraception`, `Application`.`subjects_pregnant_women`, `Application`.`subjects_nursing_women`, `Application`.`subjects_emergency_situation`, `Application`.`subjects_incapable_consent`, `Application`.`subjects_specify`, `Application`.`subjects_others`, `Application`.`subjects_others_specify`, `Application`.`investigator1_given_name`, `Application`.`investigator1_middle_name`, `Application`.`investigator1_family_name`, `Application`.`investigator1_qualification`, `Application`.`investigator1_professional_address`, `Application`.`investigator1_telephone`, `Application`.`investigator1_email`, `Application`.`organisations_transferred_`, `Application`.`number_participants`, `Application`.`notification`, `Application`.`approval_date`, `Application`.`submitted`, `Application`.`deleted`, `Application`.`deleted_date`, `Application`.`deactivated`, `Application`.`date_submitted`, `Application`.`unsubmitted`, `Application`.`initial_date_submitted`, `Application`.`admin_stopped`, `Application`.`admin_stopped_reason`, `Application`.`approved`, `Application`.`approved_reason`, `Application`.`approved_date`, `Application`.`final_report`, `Application`.`implication_results`, `Application`.`quantity_imported`, `Application`.`quantity_dispensed`, `Application`.`quantity_destroyed`, `Application`.`quantity_exported`, `Application`.`balance_site`, `Application`.`final_date`, `Application`.`ecitizen_invoice`, `Application`.`modified`, `Application`.`created`, `User`.`id`, `User`.`username`, `User`.`password`, `User`.`confirm_password`, `User`.`name`, `User`.`email`, `User`.`national_id_number`, `User`.`sponsor`, `User`.`sponsor_email`, `User`.`qualification`, `User`.`phone_no`, `User`.`name_of_institution`, `User`.`institution_physical`, `User`.`institution_address`, `User`.`institution_contact`, `User`.`county_id`, `User`.`country_id`, `User`.`group_id`, `User`.`activation_key`, `User`.`forgot_password`, `User`.`is_active`, `User`.`deactivated`, `User`.`created`, `User`.`modified`, `TrialStatus`.`id`, `TrialStatus`.`value`, `TrialStatus`.`name`, `TrialStatus`.`created`, `TrialStatus`.`modified` FROM `ctr`.`applications` AS `Application` LEFT JOIN `ctr`.`users` AS `User` ON (`Application`.`user_id` = `User`.`id`) LEFT JOIN `ctr`.`trial_statuses` AS `TrialStatus` ON (`Application`.`trial_status_id` = `TrialStatus`.`id`) WHERE `Application`.`id` = 124 AND `Application`.`deleted` = '0' LIMIT 1	1	1	1
SELECT `Review`.`id`, `Review`.`user_id`, `Review`.`application_id`, `Review`.`type`, `Review`.`assessment_type`, `Review`.`title`, `Review`.`text`, `Review`.`summary`, `Review`.`recommendation`, `Review`.`notified`, `Review`.`accepted`, `Review`.`conflict`, `Review`.`status`, `Review`.`created`, `Review`.`modified` FROM `ctr`.`reviews` AS `Review` WHERE `Review`.`application_id` = (124)	5	5	1	maybe slow
SELECT `ActiveInspector`.`id`, `ActiveInspector`.`user_id`, `ActiveInspector`.`application_id`, `ActiveInspector`.`type`, `ActiveInspector`.`assessment_type`, `ActiveInspector`.`title`, `ActiveInspector`.`text`, `ActiveInspector`.`summary`, `ActiveInspector`.`recommendation`, `ActiveInspector`.`notified`, `ActiveInspector`.`accepted`, `ActiveInspector`.`conflict`, `ActiveInspector`.`status`, `ActiveInspector`.`created`, `ActiveInspector`.`modified` FROM `ctr`.`active_inspectors` AS `ActiveInspector` WHERE `ActiveInspector`.`application_id` = (124)	0	0	1	maybe slow
SELECT `ManagerReview`.`id`, `ManagerReview`.`user_id`, `ManagerReview`.`application_id`, `ManagerReview`.`type`, `ManagerReview`.`assessment_type`, `ManagerReview`.`title`, `ManagerReview`.`text`, `ManagerReview`.`summary`, `ManagerReview`.`recommendation`, `ManagerReview`.`notified`, `ManagerReview`.`accepted`, `ManagerReview`.`conflict`, `ManagerReview`.`status`, `ManagerReview`.`created`, `ManagerReview`.`modified` FROM `ctr`.`reviews` AS `ManagerReview` WHERE `ManagerReview`.`application_id` = (124)	5	5	1	maybe slow
SELECT `Acceptance`.`id`, `Acceptance`.`user_id`, `Acceptance`.`application_id`, `Acceptance`.`type`, `Acceptance`.`assessment_type`, `Acceptance`.`title`, `Acceptance`.`text`, `Acceptance`.`summary`, `Acceptance`.`recommendation`, `Acceptance`.`notified`, `Acceptance`.`accepted`, `Acceptance`.`conflict`, `Acceptance`.`status`, `Acceptance`.`created`, `Acceptance`.`modified` FROM `ctr`.`reviews` AS `Acceptance` WHERE `Acceptance`.`type` = 'acceptance' AND `Acceptance`.`application_id` = (124)	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` = (124)	1	1	1
SELECT `InvestigatorContact`.`id`, `InvestigatorContact`.`application_id`, `InvestigatorContact`.`given_name`, `InvestigatorContact`.`middle_name`, `InvestigatorContact`.`family_name`, `InvestigatorContact`.`qualification`, `InvestigatorContact`.`professional_address`, `InvestigatorContact`.`telephone`, `InvestigatorContact`.`email`, `InvestigatorContact`.`created`, `InvestigatorContact`.`modified` FROM `ctr`.`investigator_contacts` AS `InvestigatorContact` WHERE `InvestigatorContact`.`application_id` = (124)	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` = (124)	8	8	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` = (124)	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` = (124)	1	1	0
SELECT `AnnualLetter`.`id`, `AnnualLetter`.`application_id`, `AnnualLetter`.`approval_no`, `AnnualLetter`.`type`, `AnnualLetter`.`content`, `AnnualLetter`.`qrcode`, `AnnualLetter`.`approver`, `AnnualLetter`.`approval_date`, `AnnualLetter`.`expiry_date`, `AnnualLetter`.`status`, `AnnualLetter`.`deleted`, `AnnualLetter`.`deleted_date`, `AnnualLetter`.`created`, `AnnualLetter`.`modified` FROM `ctr`.`annual_letters` AS `AnnualLetter` WHERE `AnnualLetter`.`deleted` = '0' AND `AnnualLetter`.`application_id` = (124)	7	7	1	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` = (124)	0	0	0
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` = (124)	0	0	0
SELECT `AmendmentApprovalSummary`.`id`, `AmendmentApprovalSummary`.`application_id`, `AmendmentApprovalSummary`.`approval_no`, `AmendmentApprovalSummary`.`amendment`, `AmendmentApprovalSummary`.`content`, `AmendmentApprovalSummary`.`approver`, `AmendmentApprovalSummary`.`approval_date`, `AmendmentApprovalSummary`.`status`, `AmendmentApprovalSummary`.`deleted`, `AmendmentApprovalSummary`.`deleted_date`, `AmendmentApprovalSummary`.`created`, `AmendmentApprovalSummary`.`modified` FROM `ctr`.`amendment_approvals` AS `AmendmentApprovalSummary` WHERE `AmendmentApprovalSummary`.`status` = 'summary' AND `AmendmentApprovalSummary`.`application_id` = (124)	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` = (124)	1	1	0
SELECT `SiteDetail`.`id`, `SiteDetail`.`application_id`, `SiteDetail`.`county_id`, `SiteDetail`.`site_name`, `SiteDetail`.`physical_address`, `SiteDetail`.`contact_details`, `SiteDetail`.`contact_person`, `SiteDetail`.`site_capacity`, `SiteDetail`.`misc`, `SiteDetail`.`created`, `SiteDetail`.`modified` FROM `ctr`.`site_details` AS `SiteDetail` WHERE `SiteDetail`.`application_id` = (124)	1	1	1
SELECT `Placebo`.`id`, `Placebo`.`application_id`, `Placebo`.`placebo_present`, `Placebo`.`pharmaceutical_form`, `Placebo`.`route_of_administration`, `Placebo`.`composition`, `Placebo`.`identical_indp`, `Placebo`.`major_ingredients`, `Placebo`.`created`, `Placebo`.`modified` FROM `ctr`.`placebos` AS `Placebo` WHERE `Placebo`.`application_id` = (124)	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` = (124)	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` = (124)	0	0	1	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` = (124)	0	0	1	maybe slow
SELECT `Ciom`.`id`, `Ciom`.`application_id`, `Ciom`.`reference_no`, `Ciom`.`user_id`, `Ciom`.`reporter_email`, `Ciom`.`e2b_content`, `Ciom`.`e2b_file`, `Ciom`.`file`, `Ciom`.`dirname`, `Ciom`.`basename`, `Ciom`.`checksum`, `Ciom`.`alternative`, `Ciom`.`group`, `Ciom`.`description`, `Ciom`.`created`, `Ciom`.`modified` FROM `ctr`.`cioms` AS `Ciom` WHERE `Ciom`.`application_id` = (124)	0	0	1	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` = (124)	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` = (124)	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` = (124)	0	0	0
SELECT `Attachment`.`id`, `Attachment`.`model`, `Attachment`.`file`, `Attachment`.`foreign_key`, `Attachment`.`dirname`, `Attachment`.`basename`, `Attachment`.`checksum`, `Attachment`.`alternative`, `Attachment`.`group`, `Attachment`.`description`, `Attachment`.`year`, `Attachment`.`file_date`, `Attachment`.`pocket_name`, `Attachment`.`version_no`, `Attachment`.`created`, `Attachment`.`modified`, (CONCAT_WS('/', dirname, basename)) AS `Attachment__path` FROM `ctr`.`attachments` AS `Attachment` WHERE `Attachment`.`model` = 'Application' AND `Attachment`.`group` = 'attachment' AND `Attachment`.`foreign_key` = (124)	0	0	2	maybe slow
SELECT `AnnualApproval`.`id`, `AnnualApproval`.`model`, `AnnualApproval`.`file`, `AnnualApproval`.`foreign_key`, `AnnualApproval`.`dirname`, `AnnualApproval`.`basename`, `AnnualApproval`.`checksum`, `AnnualApproval`.`alternative`, `AnnualApproval`.`group`, `AnnualApproval`.`description`, `AnnualApproval`.`year`, `AnnualApproval`.`file_date`, `AnnualApproval`.`pocket_name`, `AnnualApproval`.`version_no`, `AnnualApproval`.`created`, `AnnualApproval`.`modified`, (CONCAT_WS('/', dirname, basename)) AS `AnnualApproval__path` FROM `ctr`.`attachments` AS `AnnualApproval` WHERE `AnnualApproval`.`model` = 'AnnualApproval' AND `AnnualApproval`.`foreign_key` = (124)	14	14	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` = (124)	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` = (124)	0	0	1	maybe slow
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` = (124)	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` = (124)	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_explanation`, `Deviation`.`study_impact`, `Deviation`.`status`, `Deviation`.`deleted`, `Deviation`.`deleted_date`, `Deviation`.`created`, `Deviation`.`modified` FROM `ctr`.`deviations` AS `Deviation` WHERE `Deviation`.`application_id` = (124)	0	0	0
SELECT `Document`.`id`, `Document`.`model`, `Document`.`file`, `Document`.`foreign_key`, `Document`.`dirname`, `Document`.`basename`, `Document`.`checksum`, `Document`.`alternative`, `Document`.`group`, `Document`.`description`, `Document`.`year`, `Document`.`file_date`, `Document`.`pocket_name`, `Document`.`version_no`, `Document`.`created`, `Document`.`modified`, (CONCAT_WS('/', dirname, basename)) AS `Document__path` FROM `ctr`.`attachments` AS `Document` WHERE `Document`.`model` = 'Application' AND `Document`.`group` = 'document' AND `Document`.`foreign_key` = (124)	0	0	2	maybe slow
SELECT `CoverLetter`.`id`, `CoverLetter`.`model`, `CoverLetter`.`file`, `CoverLetter`.`foreign_key`, `CoverLetter`.`dirname`, `CoverLetter`.`basename`, `CoverLetter`.`checksum`, `CoverLetter`.`alternative`, `CoverLetter`.`group`, `CoverLetter`.`description`, `CoverLetter`.`year`, `CoverLetter`.`file_date`, `CoverLetter`.`pocket_name`, `CoverLetter`.`version_no`, `CoverLetter`.`created`, `CoverLetter`.`modified`, (CONCAT_WS('/', dirname, basename)) AS `CoverLetter__path` FROM `ctr`.`attachments` AS `CoverLetter` WHERE `CoverLetter`.`model` = 'Application' AND `CoverLetter`.`group` = 'cover_letter' AND `CoverLetter`.`foreign_key` = (124)	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` = (124)	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` = (124)	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` = (124)	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` = (124)	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` = (124)	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` = (124)	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` = (124)	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` = (124)	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` = (124)	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` = (124)	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` = (124)	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` = (124)	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` = (124)	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` = (124)	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` = (124)	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` = (124)	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` = (124)	0	0	0
SELECT `ProtocolOutsource`.`id`, `ProtocolOutsource`.`user_id`, `ProtocolOutsource`.`application_id`, `ProtocolOutsource`.`outsource_id`, `ProtocolOutsource`.`owner_id`, `ProtocolOutsource`.`created`, `ProtocolOutsource`.`modified` FROM `ctr`.`protocol_outsources` AS `ProtocolOutsource` WHERE `ProtocolOutsource`.`user_id` = (124)	0	0	0
SELECT `Outsource`.`id`, `Outsource`.`application_id`, `Outsource`.`user_id`, `Outsource`.`model`, `Outsource`.`username`, `Outsource`.`name`, `Outsource`.`email`, `Outsource`.`phone_no`, `Outsource`.`institution_physical`, `Outsource`.`name_of_institution`, `Outsource`.`institution_address`, `Outsource`.`institution_contact`, `Outsource`.`county_id`, `Outsource`.`country_id`, `Outsource`.`approved`, `Outsource`.`created`, `Outsource`.`modified`, `Outsource`.`accepted`, `Outsource`.`model_sae`, `Outsource`.`model_ciom`, `Outsource`.`model_dev` FROM `ctr`.`outsources` AS `Outsource` WHERE `Outsource`.`application_id` = (124)	0	0	0

Query Explain:

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

====

Timer

Memory

Peak Memory Use 16.71 MB

Message	Memory use
Component initialization	2.40 MB
Controller action start	3.58 MB
Controller render start	8.25 MB
View render complete	8.68 MB

Timers

Total Request Time: 191 (ms)

Message	Time in ms	Graph
Core Processing (Derived from $_SERVER["REQUEST_TIME"])	10.83
Event: Controller.initialize	0.26
Event: Controller.startup	0.62
Controller action	94.22
Event: Controller.beforeRender	28.90
» Processing toolbar data	28.80
Rendering View	3.30
» Event: View.beforeRender	0.03
» Rendering APP/View/Applications/view.ctp	0.58
» Event: View.afterRender	0.02
» Event: View.beforeLayout	0.02
» Rendering APP/View/Layouts/default.ctp	2.31
» » 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)
 id124
 user_id26
 application_id(null)
 is_child0
 trial_status_id4
 total_sites2
 abstract_of_study Testronimal Study Phase 2
 study_title Testronimal Study Phase 2
 laymans_summary Layman SUmmary
 short_titleTestronimal Study Phase 2
 protocol_noECCT/24/11/01
 reference_no
 version_no1
 date_of_protocol12-11-2024
 study_drugTestronimal
 disease_conditionCancer
 product_type_biologicals1
 product_type_proteins0
 product_type_immunologicals1
 product_type_vaccines0
 product_type_hormones0
 product_type_toxoid0
 product_type_chemical1
 product_type_medical_device0
 product_type_chemical_nameEndo
 product_type_medical_device_name
 comparatorNo
 comparator_name
 comparator_registered
 comparator_countries
 ecct_not_applicable0
 ecct_ref_number
 email_addressjayoma@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_applicanttest
 declaration_date120-11-2024
 declaration_principal_investigatortest
 declaration_date220-11-2024
 placebo_presentNo
 study_objectives test
 principal_inclusion_criteria test
 principal_exclusion_criteria test
 primary_end_points test
 scope_diagnosis0
 scope_prophylaxis0
 scope_therapy1
 scope_safety0
 scope_efficacy0
 scope_pharmacokinetic0
 scope_pharmacodynamic0
 scope_bioequivalence0
 scope_dose_response0
 scope_pharmacogenetic1
 scope_pharmacogenomic0
 scope_pharmacoecomomic0
 scope_others0
 scope_others_specify
 trial_human_pharmacology1
 trial_administration_humans0
 trial_bioequivalence_study1
 trial_other0
 trial_other_specify
 trial_therapeutic_exploratory0
 trial_therapeutic_confirmatory1
 trial_therapeutic_use0
 design_controlledNo
 site_capacity(null)
 staff_numbers test
 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_duration1year
 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_stateNo
 location_of_area
 single_site_physical_address
 single_site_contact_person
 single_site_telephone
 multiple_sites_member_stateNo
 multiple_countriesYes
 multiple_member_states5
 number_of_sites
 multi_country_listtest
 data_monitoring_committeeYes
 total_enrolment_per_site2000
 total_participants_worldwide2000000
 population_less_than_18_yearsNo
 population_uteroNo
 population_preterm_newbornNo
 population_newbornNo
 population_infant_and_toddlerNo
 population_childrenNo
 population_adolescentNo
 population_above_18Yes
 population_adultYes
 population_elderlyNo
 gender_female1
 gender_male0
 subjects_healthyYes
 subjects_patientsNo
 subjects_vulnerable_populationsNo
 subjects_women_child_bearingNo
 subjects_women_using_contraceptionNo
 subjects_pregnant_womenNo
 subjects_nursing_womenNo
 subjects_emergency_situationNo
 subjects_incapable_consentNo
 subjects_specify
 subjects_othersNo
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 content<h3 style="text-align: center;"> <img height="86" src="https://lh7-us.googleusercontent.com/eOWVvo3AHW74GguHveDaqdgy3YwNZqOqOO0QtscRoV4hJfcvt8Q6v4oLN3beVNvClvoD1ncu1RhB5D4iuAY-5R9h1aD2lEGqUorBVcQ0azfxsdvIz-WhbF3rA9-VQomtusnP2bNZTuYLFTC6vQ46nQ" style="background-color: transparent; color: rgb(0, 0, 0); font-family: "Bookman Old Style", serif; font-size: 11pt; white-space-collapse: preserve; margin-left: 0px; margin-top: 0px;" width="116" /></h3> MINISTRY OF HEALTH PHARMACY AND POISONS BOARD <table style="width: 100%; border:0px"> <tbody> <tr> <td style="width: 33.33%; border:0px"> <div id="left-editor"> Telegram: "MINHEALTH", Nairobi Cell phone: 0709 770 100 Email: info@pharmacyboardkenya.org Website: web.pharmacyboardkenya.org </div> </td> <td style="width: 33.33%;border:0px"> </td> <td style="width: 33.33%;border:0px"> <div id="right-editor"> Pharmacy and Poisons Board House Along Lenana Road P.O. Box 27663-00506 NAIROBI </div> </td> </tr> </tbody> </table> <address> </address> <address> When replying please quote</address> Ref. No. ECCT/1/2024-ECCT/24/11/01 5 Dec 2024 Joel Investigator, Principal Investigator ECCT/24/11/01, P.O Box 381-3558,Accra, Dear Sir/Madam, Re: ECCT/24/11/01 : Annual Approval; Testronimal Study Phase 2 Testronimal Study Phase 2. Reference is made to the above study. We acknowledge receipt of the following documents; <div style="margin-left: 15px;"> </div> After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials notes the following: :reviewer_summary_comments The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study: Testronimal Study Phase 2 ECCT/24/11/01. This approval is valid for one year and in case the study extends beyond one year from the date of this letter, you are required to seek approval before proceeding with the study. The expiry date is 5th December 2025 <ol> <li> You should ensure compliance with Kenya Legal, regulatory and GCP requirements</li> <li> All safety reports should be submitted to ECCT as per the current PPB clinical trials guidelines</li> <li> It is your responsibility to inform the PPB of any changes to the protocol, research design and procedures that could introduce new or more than minimum risk to human subjects</li> <li> You are also reminded that upon conclusion of the study, you shall be required to submit the executive summary report of the study within 30 days while a copy of the clinical study report in ICH E3 format should be submitted to us within 180 days of the study closure</li> </ol> <div> Yours Sincerely, </div> :signature :approver For Chief Executive Officer 
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
 approvermanager
 approval_date05-12-2024
 expiry_date05-12-2025
 statussubmitted
 deleted0
 deleted_date(null)
 created2024-12-05 16:14:13
 modified2024-12-05 16:14:13
 1(array)
 id2
 application_id124
 approval_noECCT/2/2024-ECCT/24/11/01
 type0
 content<h3 style="text-align: center;"> <img height="86" src="https://lh7-us.googleusercontent.com/eOWVvo3AHW74GguHveDaqdgy3YwNZqOqOO0QtscRoV4hJfcvt8Q6v4oLN3beVNvClvoD1ncu1RhB5D4iuAY-5R9h1aD2lEGqUorBVcQ0azfxsdvIz-WhbF3rA9-VQomtusnP2bNZTuYLFTC6vQ46nQ" style="background-color: transparent; color: rgb(0, 0, 0); font-family: "Bookman Old Style", serif; font-size: 11pt; white-space-collapse: preserve; margin-left: 0px; margin-top: 0px;" width="116" /></h3> MINISTRY OF HEALTH PHARMACY AND POISONS BOARD <table style="width: 100%; border:0px"> <tbody> <tr> <td style="width: 33.33%; border:0px"> <div id="left-editor"> Telegram: "MINHEALTH", Nairobi Cell phone: 0709 770 100 Email: info@pharmacyboardkenya.org Website: web.pharmacyboardkenya.org </div> </td> <td style="width: 33.33%;border:0px"> </td> <td style="width: 33.33%;border:0px"> <div id="right-editor"> Pharmacy and Poisons Board House Along Lenana Road P.O. Box 27663-00506 NAIROBI </div> </td> </tr> </tbody> </table> <address> </address> <address> When replying please quote</address> Ref. No. ECCT/2/2024-ECCT/24/11/01 5 Dec 2024 Joel Investigator, Principal Investigator ECCT/24/11/01, P.O Box 381-3558,Accra, Dear Sir/Madam, Re: ECCT/24/11/01 : Annual Approval; Testronimal Study Phase 2 Testronimal Study Phase 2. Reference is made to the above study. We acknowledge receipt of the following documents; <div style="margin-left: 15px;"> </div> After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials notes the following: :reviewer_summary_comments The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study: Testronimal Study Phase 2 ECCT/24/11/01. This approval is valid for one year and in case the study extends beyond one year from the date of this letter, you are required to seek approval before proceeding with the study. The expiry date is 5th December 2025 <ol> <li> You should ensure compliance with Kenya Legal, regulatory and GCP requirements</li> <li> All safety reports should be submitted to ECCT as per the current PPB clinical trials guidelines</li> <li> It is your responsibility to inform the PPB of any changes to the protocol, research design and procedures that could introduce new or more than minimum risk to human subjects</li> <li> You are also reminded that upon conclusion of the study, you shall be required to submit the executive summary report of the study within 30 days while a copy of the clinical study report in ICH E3 format should be submitted to us within 180 days of the study closure</li> </ol> <div> Yours Sincerely, </div> :signature :approver For Chief Executive Officer 
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
 approvermanager
 approval_date05-12-2024
 expiry_date05-12-2025
 statussubmitted
 deleted0
 deleted_date(null)
 created2024-12-05 16:14:48
 modified2024-12-05 16:14:48
 2(array)
 id3
 application_id124
 approval_noECCT/3/2024-ECCT/24/11/01
 type0
 content<h3 style="text-align: center;"> <img height="86" src="https://lh7-us.googleusercontent.com/eOWVvo3AHW74GguHveDaqdgy3YwNZqOqOO0QtscRoV4hJfcvt8Q6v4oLN3beVNvClvoD1ncu1RhB5D4iuAY-5R9h1aD2lEGqUorBVcQ0azfxsdvIz-WhbF3rA9-VQomtusnP2bNZTuYLFTC6vQ46nQ" style="background-color: transparent; color: rgb(0, 0, 0); font-family: "Bookman Old Style", serif; font-size: 11pt; white-space-collapse: preserve; margin-left: 0px; margin-top: 0px;" width="116" /></h3> MINISTRY OF HEALTH PHARMACY AND POISONS BOARD <table style="width: 100%; border:0px"> <tbody> <tr> <td style="width: 33.33%; border:0px"> <div id="left-editor"> Telegram: "MINHEALTH", Nairobi Cell phone: 0709 770 100 Email: info@pharmacyboardkenya.org Website: web.pharmacyboardkenya.org </div> </td> <td style="width: 33.33%;border:0px"> </td> <td style="width: 33.33%;border:0px"> <div id="right-editor"> Pharmacy and Poisons Board House Along Lenana Road P.O. Box 27663-00506 NAIROBI </div> </td> </tr> </tbody> </table> <address> </address> <address> When replying please quote</address> Ref. No. ECCT/3/2024-ECCT/24/11/01 5 Dec 2024 Joel Investigator, Principal Investigator ECCT/24/11/01, P.O Box 381-3558,Accra, Dear Sir/Madam, Re: ECCT/24/11/01 : Annual Approval; Testronimal Study Phase 2 Testronimal Study Phase 2. Reference is made to the above study. We acknowledge receipt of the following documents; <div style="margin-left: 15px;"> </div> After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials notes the following: :reviewer_summary_comments The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study: Testronimal Study Phase 2 ECCT/24/11/01. This approval is valid for one year and in case the study extends beyond one year from the date of this letter, you are required to seek approval before proceeding with the study. The expiry date is 5th December 2025 <ol> <li> You should ensure compliance with Kenya Legal, regulatory and GCP requirements</li> <li> All safety reports should be submitted to ECCT as per the current PPB clinical trials guidelines</li> <li> It is your responsibility to inform the PPB of any changes to the protocol, research design and procedures that could introduce new or more than minimum risk to human subjects</li> <li> You are also reminded that upon conclusion of the study, you shall be required to submit the executive summary report of the study within 30 days while a copy of the clinical study report in ICH E3 format should be submitted to us within 180 days of the study closure</li> </ol> <div> Yours Sincerely, </div> :signature :approver For Chief Executive Officer 
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
 approvermanager
 approval_date05-12-2024
 expiry_date05-12-2025
 statussubmitted
 deleted0
 deleted_date(null)
 created2024-12-05 16:17:13
 modified2024-12-05 16:17:13
 3(array)
 id4
 application_id124
 approval_noECCT/4/2024-ECCT/24/11/01
 type0
 content<h3 style="text-align: center;"> <img height="86" src="https://lh7-us.googleusercontent.com/eOWVvo3AHW74GguHveDaqdgy3YwNZqOqOO0QtscRoV4hJfcvt8Q6v4oLN3beVNvClvoD1ncu1RhB5D4iuAY-5R9h1aD2lEGqUorBVcQ0azfxsdvIz-WhbF3rA9-VQomtusnP2bNZTuYLFTC6vQ46nQ" style="background-color: transparent; color: rgb(0, 0, 0); font-family: "Bookman Old Style", serif; font-size: 11pt; white-space-collapse: preserve; margin-left: 0px; margin-top: 0px;" width="116" /></h3> MINISTRY OF HEALTH PHARMACY AND POISONS BOARD <table style="width: 100%; border:0px"> <tbody> <tr> <td style="width: 33.33%; border:0px"> <div id="left-editor"> Telegram: "MINHEALTH", Nairobi Cell phone: 0709 770 100 Email: info@pharmacyboardkenya.org Website: web.pharmacyboardkenya.org </div> </td> <td style="width: 33.33%;border:0px"> </td> <td style="width: 33.33%;border:0px"> <div id="right-editor"> Pharmacy and Poisons Board House Along Lenana Road P.O. Box 27663-00506 NAIROBI </div> </td> </tr> </tbody> </table> <address> </address> <address> When replying please quote</address> Ref. No. ECCT/4/2024-ECCT/24/11/01 5 Dec 2024 Joel Investigator, Principal Investigator ECCT/24/11/01, P.O Box 381-3558,Accra, Dear Sir/Madam, Re: ECCT/24/11/01 : Annual Approval; Testronimal Study Phase 2 Testronimal Study Phase 2. Reference is made to the above study. We acknowledge receipt of the following documents; <div style="margin-left: 15px;"> </div> After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials notes the following: :reviewer_summary_comments The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study: Testronimal Study Phase 2 ECCT/24/11/01. This approval is valid for one year and in case the study extends beyond one year from the date of this letter, you are required to seek approval before proceeding with the study. The expiry date is 5th December 2025 <ol> <li> You should ensure compliance with Kenya Legal, regulatory and GCP requirements</li> <li> All safety reports should be submitted to ECCT as per the current PPB clinical trials guidelines</li> <li> It is your responsibility to inform the PPB of any changes to the protocol, research design and procedures that could introduce new or more than minimum risk to human subjects</li> <li> You are also reminded that upon conclusion of the study, you shall be required to submit the executive summary report of the study within 30 days while a copy of the clinical study report in ICH E3 format should be submitted to us within 180 days of the study closure</li> </ol> <div> Yours Sincerely, </div> :signature :approver For Chief Executive Officer 
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 approvermanager
 approval_date05-12-2024
 expiry_date05-12-2025
 statussubmitted
 deleted0
 deleted_date(null)
 created2024-12-05 16:19:03
 modified2024-12-05 16:19:03
 4(array)
 id5
 application_id124
 approval_noECCT/5/2024-ECCT/24/11/01
 type0
 content<h3 style="text-align: center;"> <img height="86" src="https://lh7-us.googleusercontent.com/eOWVvo3AHW74GguHveDaqdgy3YwNZqOqOO0QtscRoV4hJfcvt8Q6v4oLN3beVNvClvoD1ncu1RhB5D4iuAY-5R9h1aD2lEGqUorBVcQ0azfxsdvIz-WhbF3rA9-VQomtusnP2bNZTuYLFTC6vQ46nQ" style="background-color: transparent; color: rgb(0, 0, 0); font-family: "Bookman Old Style", serif; font-size: 11pt; white-space-collapse: preserve; margin-left: 0px; margin-top: 0px;" width="116" /></h3> MINISTRY OF HEALTH PHARMACY AND POISONS BOARD <table style="width: 100%; border:0px"> <tbody> <tr> <td style="width: 33.33%; border:0px"> <div id="left-editor"> Telegram: "MINHEALTH", Nairobi Cell phone: 0709 770 100 Email: info@pharmacyboardkenya.org Website: web.pharmacyboardkenya.org </div> </td> <td style="width: 33.33%;border:0px"> </td> <td style="width: 33.33%;border:0px"> <div id="right-editor"> Pharmacy and Poisons Board House Along Lenana Road P.O. Box 27663-00506 NAIROBI </div> </td> </tr> </tbody> </table> <address> </address> <address> When replying please quote</address> Ref. No. ECCT/5/2024-ECCT/24/11/01 5 Dec 2024 Joel Investigator, Principal Investigator ECCT/24/11/01, P.O Box 381-3558,Accra, Dear Sir/Madam, Re: ECCT/24/11/01 : Annual Approval; Testronimal Study Phase 2 Testronimal Study Phase 2. Reference is made to the above study. We acknowledge receipt of the following documents; <div style="margin-left: 15px;"> </div> After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials notes the following: 1.) Trial category comments Eligendi natus liber Trial phase comments (if in disagreement with the study phase proposed): Reprehenderit tenet Assessor’s discussion on the clinical development: Ipsam ut dolore expe Clinical Trial Rationale comments Earum ut obcaecati e Primary objectives comments In velit vel at fac Secondary objectives comments Quo quis aliquid mol Study population comments Quisquam dolor asper Inclusion criteria comments Ullam aspernatur sit Exclusion criteria comments Amet minima tempora Vulnerable populations comments Recusandae Quasi pe Study plan and design comments Quae nostrud sequi i Study treatment comments Tenetur ut doloribus Comparator IMP(s) comments Aute asperiores anim Placebo comments Vero blanditiis vel Auxilliary medicinal product(s) comments Architecto enim ad d Additional considerations comments Quia sapiente labori Safety comments Nam lorem velit aut Blinding and unblinding comments Similique qui est i Contraception measures comments Recusandae Pariatur Discontinuation criteria comments Beatae ipsam et even Other concomitant comments Commodi dicta mollit Safety and Monitoring comments Similique voluptatem Reference Safety Information comments Eveniet aut ut fugi Data Safety Monitoring Committee comments Animi quia dolor ev Definition of the end of the trial comments Aut cumque nostrum i Biological samples used in the study comments Qui quod ducimus om Data protection comments Velit qui consequat Recruitment and informed consent procedures comment Vel est perferendis Comments on the benefit/risk: Eius sit ut eveniet Overall comment/ conclusion on the clinical assessment: Aut assumenda occaec 1.5.1 REQUESTS FOR ADDITIONAL INFORMATION Ipsa maiores optio The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study: Testronimal Study Phase 2 ECCT/24/11/01. This approval is valid for one year and in case the study extends beyond one year from the date of this letter, you are required to seek approval before proceeding with the study. The expiry date is 5th December 2025 <ol> <li> You should ensure compliance with Kenya Legal, regulatory and GCP requirements</li> <li> All safety reports should be submitted to ECCT as per the current PPB clinical trials guidelines</li> <li> It is your responsibility to inform the PPB of any changes to the protocol, research design and procedures that could introduce new or more than minimum risk to human subjects</li> <li> You are also reminded that upon conclusion of the study, you shall be required to submit the executive summary report of the study within 30 days while a copy of the clinical study report in ICH E3 format should be submitted to us within 180 days of the study closure</li> </ol> <div> Yours Sincerely, </div> :signature :approver For Chief Executive Officer 
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
 approvermanager
 approval_date05-12-2024
 expiry_date05-12-2025
 statussubmitted
 deleted0
 deleted_date(null)
 created2024-12-05 16:20:00
 modified2024-12-05 16:20:00
 5(array)
 id6
 application_id124
 approval_noECCT/6/2024-ECCT/24/11/01
 type0
 content<h3 style="text-align: center;"> <img height="86" src="https://lh7-us.googleusercontent.com/eOWVvo3AHW74GguHveDaqdgy3YwNZqOqOO0QtscRoV4hJfcvt8Q6v4oLN3beVNvClvoD1ncu1RhB5D4iuAY-5R9h1aD2lEGqUorBVcQ0azfxsdvIz-WhbF3rA9-VQomtusnP2bNZTuYLFTC6vQ46nQ" style="background-color: transparent; color: rgb(0, 0, 0); font-family: "Bookman Old Style", serif; font-size: 11pt; white-space-collapse: preserve; margin-left: 0px; margin-top: 0px;" width="116" /></h3> MINISTRY OF HEALTH PHARMACY AND POISONS BOARD <table style="width: 100%; border:0px"> <tbody> <tr> <td style="width: 33.33%; border:0px"> <div id="left-editor"> Telegram: "MINHEALTH", Nairobi Cell phone: 0709 770 100 Email: info@pharmacyboardkenya.org Website: web.pharmacyboardkenya.org </div> </td> <td style="width: 33.33%;border:0px"> </td> <td style="width: 33.33%;border:0px"> <div id="right-editor"> Pharmacy and Poisons Board House Along Lenana Road P.O. Box 27663-00506 NAIROBI </div> </td> </tr> </tbody> </table> <address> </address> <address> When replying please quote</address> Ref. No. ECCT/6/2024-ECCT/24/11/01 5 Dec 2024 Joel Investigator, Principal Investigator ECCT/24/11/01, P.O Box 381-3558,Accra, Dear Sir/Madam, Re: ECCT/24/11/01 : Annual Approval; Testronimal Study Phase 2 Testronimal Study Phase 2. Reference is made to the above study. We acknowledge receipt of the following documents; <div style="margin-left: 15px;"> </div> After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials notes the following: Trial category comments Eligendi natus liber Trial phase comments (if in disagreement with the study phase proposed): Reprehenderit tenet Assessor’s discussion on the clinical development: Ipsam ut dolore expe Clinical Trial Rationale comments Earum ut obcaecati e Primary objectives comments In velit vel at fac Secondary objectives comments Quo quis aliquid mol Study population comments Quisquam dolor asper Inclusion criteria comments Ullam aspernatur sit Exclusion criteria comments Amet minima tempora Vulnerable populations comments Recusandae Quasi pe Study plan and design comments Quae nostrud sequi i Study treatment comments Tenetur ut doloribus Comparator IMP(s) comments Aute asperiores anim Placebo comments Vero blanditiis vel Auxilliary medicinal product(s) comments Architecto enim ad d Additional considerations comments Quia sapiente labori Safety comments Nam lorem velit aut Blinding and unblinding comments Similique qui est i Contraception measures comments Recusandae Pariatur Discontinuation criteria comments Beatae ipsam et even Other concomitant comments Commodi dicta mollit Safety and Monitoring comments Similique voluptatem Reference Safety Information comments Eveniet aut ut fugi Data Safety Monitoring Committee comments Animi quia dolor ev Definition of the end of the trial comments Aut cumque nostrum i Biological samples used in the study comments Qui quod ducimus om Data protection comments Velit qui consequat Recruitment and informed consent procedures comment Vel est perferendis Comments on the benefit/risk: Eius sit ut eveniet Overall comment/ conclusion on the clinical assessment: Aut assumenda occaec 1.5.1 REQUESTS FOR ADDITIONAL INFORMATION Ipsa maiores optio The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study: Testronimal Study Phase 2 ECCT/24/11/01. This approval is valid for one year and in case the study extends beyond one year from the date of this letter, you are required to seek approval before proceeding with the study. The expiry date is 5th December 2025 <ol> <li> You should ensure compliance with Kenya Legal, regulatory and GCP requirements</li> <li> All safety reports should be submitted to ECCT as per the current PPB clinical trials guidelines</li> <li> It is your responsibility to inform the PPB of any changes to the protocol, research design and procedures that could introduce new or more than minimum risk to human subjects</li> <li> You are also reminded that upon conclusion of the study, you shall be required to submit the executive summary report of the study within 30 days while a copy of the clinical study report in ICH E3 format should be submitted to us within 180 days of the study closure</li> </ol> <div> Yours Sincerely, </div> :signature :approver For Chief Executive Officer 
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
 approvermanager
 approval_date05-12-2024
 expiry_date05-12-2025
 statussubmitted
 deleted0
 deleted_date(null)
 created2024-12-05 16:20:56
 modified2024-12-05 16:20:56
 6(array)
 id7
 application_id124
 approval_noECCT/7/2024-ECCT/24/11/01
 type0
 content<h3 style="text-align: center;"> <img height="86" src="https://lh7-us.googleusercontent.com/eOWVvo3AHW74GguHveDaqdgy3YwNZqOqOO0QtscRoV4hJfcvt8Q6v4oLN3beVNvClvoD1ncu1RhB5D4iuAY-5R9h1aD2lEGqUorBVcQ0azfxsdvIz-WhbF3rA9-VQomtusnP2bNZTuYLFTC6vQ46nQ" style="background-color: transparent; color: rgb(0, 0, 0); font-family: "Bookman Old Style", serif; font-size: 11pt; white-space-collapse: preserve; margin-left: 0px; margin-top: 0px;" width="116" /></h3> MINISTRY OF HEALTH PHARMACY AND POISONS BOARD <table style="width: 100%; border:0px"> <tbody> <tr> <td style="width: 33.33%; border:0px"> <div id="left-editor"> Telegram: "MINHEALTH", Nairobi Cell phone: 0709 770 100 Email: info@pharmacyboardkenya.org Website: web.pharmacyboardkenya.org </div> </td> <td style="width: 33.33%;border:0px"> </td> <td style="width: 33.33%;border:0px"> <div id="right-editor"> Pharmacy and Poisons Board House Along Lenana Road P.O. Box 27663-00506 NAIROBI </div> </td> </tr> </tbody> </table> <address> </address> <address> When replying please quote</address> Ref. No. ECCT/7/2024-ECCT/24/11/01 5 Dec 2024 Joel Investigator, Principal Investigator ECCT/24/11/01, P.O Box 381-3558,Accra, Dear Sir/Madam, Re: ECCT/24/11/01 : Initial Approval; Testronimal Study Phase 2 Testronimal Study Phase 2. 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/1014">screenshot_from_2024_11_20_09_28_39.png</a> dated 20th November 2024 Version 1 2. The Study Protocol <a href="/attachments/download/1015">screenshot_from_2024_11_20_08_49_24.png</a> dated 20th November 2024 Version 1 3. Registration of the study at Pan African Clinical Trials Registry https://pactr.samrc.ac.za <a href="/attachments/download/1016">screenshot_from_2024_11_20_08_32_41.png</a> dated 20th November 2024 Version 1 4. Patient Information leaflet and Informed consent form <a href="/attachments/download/1017">screenshot_from_2024_11_19_16_05_00.png</a> dated 20th November 2024 Version 2 5. Investigators Brochure/Package inserts <a href="/attachments/download/1018">screenshot_from_2024_11_20_08_49_24_2.png</a> dated 20th November 2024 Version 1 6. Investigational Medicinal Product Dossier (IMPD) <a href="/attachments/download/1019">screenshot_from_2024_11_20_09_28_39_2.png</a> dated 20th November 2024 Version 4 7. Adequate data and information from previous studies and Phases to support carrying out of the current study <a href="/attachments/download/1020">screenshot_from_2024_11_19_09_56_21.png</a> dated 20th November 2024 Version 5 8. GMP certificate of the investigational product from the site of manufacture <a href="/attachments/download/1021">screenshot_from_2024_11_20_08_44_32.png</a> dated 20th November 2024 Version 2 9. Certificate of Analysis of the investigational product <a href="/attachments/download/1022">screenshot_from_2024_11_20_08_49_24_3.png</a> dated 19th November 2024 Version 3 10. Pictorial Sample of the investigational products. This sample should include the text of the labeling to be used <a href="/attachments/download/1023">screenshot_from_2024_11_20_09_28_39_3.png</a> dated 20th November 2024 Version 3 11. 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/1024">screenshot_from_2024_11_20_09_28_39_4.png</a> dated 20th November 2024 Version 2 12. Evidence of contractual agreement between sponsor and Principal Investigator. <a href="/attachments/download/1025">screenshot_from_2024_11_20_09_28_39_5.png</a> dated 12th November 2024 Version 2 13. Evidence of recent GCP training of the core study staff <a href="/attachments/download/1026">screenshot_from_2024_11_20_08_41_15.png</a> dated 20th November 2024 Version 3 14. DSMB Charter including the composition and meeting schedule <a href="/attachments/download/1027">screenshot_from_2024_11_20_08_32_41_2.png</a> dated 19th November 2024 Version 2 15. Detailed budget of the study <a href="/attachments/download/1028">screenshot_from_2024_11_20_08_32_41_3.png</a> dated 19th November 2024 Version 2 16. Financial declaration by Sponsor and/or PI <a href="/attachments/download/1029">screenshot_from_2024_11_19_09_56_21_2.png</a> dated 13th November 2024 Version 2 17. Signed Declaration by Sponsor or Principal investigator that the study will be carried out according to the protocol and applicable laws, regulations and GCP requirements. <a href="/attachments/download/1030">screenshot_from_2024_11_20_08_32_41_4.png</a> dated 20th November 2024 Version 2 18. Indemnity cover for PI, investigators and study Pharmacist. <a href="/attachments/download/1031">screenshot_from_2024_11_19_09_56_21_3.png</a> dated 13th November 2024 Version 2 19. Clinical Trials Insurance cover for study participants <a href="/attachments/download/1032">screenshot_from_2024_11_20_08_49_24_4.png</a> dated 18th November 2024 Version 3 20. Copy of favorable opinion letter from the local Ethics Review Committee (ERC). <a href="/attachments/download/1033">screenshot_from_2024_11_20_09_28_39_6.png</a> dated 12th November 2024 Version 4 21. Copy of current Practice Licenses for the Investigators and study Pharmacist <a href="/attachments/download/1034">screenshot_from_2024_11_20_09_28_39_7.png</a> dated 20th November 2024 Version 2 22. Copy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable <a href="/attachments/download/1035">screenshot_from_2024_11_20_08_32_41_5.png</a> dated 19th November 2024 Version 3 23. 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/1036">screenshot_from_2024_11_19_16_05_00_2.png</a> dated 13th November 2024 Version 4 24. Payment of fees <a href="/attachments/download/1037">screenshot_from_2024_11_19_16_05_00_3.png</a> dated 18th November 2024 Version 4 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/1038">screenshot_from_2024_11_19_16_05_00_4.png</a> dated 20th November 2024 Version 2 26. Statistical Analysis Plan <a href="/attachments/download/1039">screenshot_from_2024_11_20_09_21_21.png</a> dated 19th November 2024 Version 3 27. Signed Checklist <a href="/attachments/download/1040">screenshot_from_2024_11_20_08_32_41_6.png</a> dated 20th November 2024 Version 3 28. Stability data of the investigational product <a href="/attachments/download/1041">screenshot_from_2024_11_20_09_21_21_2.png</a> dated 20th November 2024 Version 5</div> After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials notes the following: Trial category comments Eligendi natus liber Trial phase comments (if in disagreement with the study phase proposed): Reprehenderit tenet Assessor’s discussion on the clinical development: Ipsam ut dolore expe Clinical Trial Rationale comments Earum ut obcaecati e Primary objectives comments In velit vel at fac Secondary objectives comments Quo quis aliquid mol Study population comments Quisquam dolor asper Inclusion criteria comments Ullam aspernatur sit Exclusion criteria comments Amet minima tempora Vulnerable populations comments Recusandae Quasi pe Study plan and design comments Quae nostrud sequi i Study treatment comments Tenetur ut doloribus Comparator IMP(s) comments Aute asperiores anim Placebo comments Vero blanditiis vel Auxilliary medicinal product(s) comments Architecto enim ad d Additional considerations comments Quia sapiente labori Safety comments Nam lorem velit aut Blinding and unblinding comments Similique qui est i Contraception measures comments Recusandae Pariatur Discontinuation criteria comments Beatae ipsam et even Other concomitant comments Commodi dicta mollit Safety and Monitoring comments Similique voluptatem Reference Safety Information comments Eveniet aut ut fugi Data Safety Monitoring Committee comments Animi quia dolor ev Definition of the end of the trial comments Aut cumque nostrum i Biological samples used in the study comments Qui quod ducimus om Data protection comments Velit qui consequat Recruitment and informed consent procedures comment Vel est perferendis Comments on the benefit/risk: Eius sit ut eveniet Overall comment/ conclusion on the clinical assessment: Aut assumenda occaec 1.5.1 REQUESTS FOR ADDITIONAL INFORMATION Ipsa maiores optio The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study: Testronimal Study Phase 2 ECCT/24/11/01. This approval is valid for one year and in case the study extends beyond one year from the date of this letter, you are required to seek approval before proceeding with the study. The expiry date is 21st November 2025 <ol> <li> You should ensure compliance with Kenya Legal, regulatory and GCP requirements</li> <li> All safety reports should be submitted to ECCT as per the current PPB clinical trials guidelines</li> <li> It is your responsibility to inform the PPB of any changes to the protocol, research design and procedures that could introduce new or more than minimum risk to human subjects</li> <li> You are also reminded that upon conclusion of the study, you shall be required to submit the executive summary report of the study within 30 days while a copy of the clinical study report in ICH E3 format should be submitted to us within 180 days of the study closure</li> </ol> <div> Yours Sincerely, </div> :signature :approver For Chief Executive Officer 
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 created2024-11-20 09:46:47
 modified2024-11-20 09:47:01
 pathimg/screenshot_from_2024_11_20_08_32_41_6.png
 27(array)
 id1041
 modelChecklist
 file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2024_11_20_09_21_21_2.png
 foreign_key124
 dirnameimg
 basenamescreenshot_from_2024_11_20_09_21_21_2.png
 checksum20f2714d8411199bfa357112500aaee9
 alternative(null)
 groupapplicant_stability_data
 descriptionStability data of the investigational product *
 year(null)
 file_date20-11-2024
 pocket_nameapplicant_stability_data
 version_no5
 created2024-11-20 09:46:57
 modified2024-11-20 09:46:57
 pathimg/screenshot_from_2024_11_20_09_21_21_2.png
 StudyMonitor(empty)
 ProtocolOutsource(empty)
 Outsource(empty)
- redir
- $request->data(empty)
- $this->validationErrors(array)
 Permission(empty)
 Aro(empty)
 Aco(empty)
 Application(empty)
 User(empty)
 TrialStatus(empty)
 Review(empty)
 ActiveInspector(empty)
 ManagerReview(empty)
 Acceptance(empty)
 Amendment(empty)
 InvestigatorContact(empty)
 ApplicationStage(empty)
 Pharmacist(empty)
 EthicalCommittee(empty)
 AnnualLetter(empty)
 AmendmentLetter(empty)
 AmendmentApproval(empty)
 AmendmentApprovalSummary(empty)
 Organization(empty)
 SiteDetail(empty)
 Placebo(empty)
 Sponsor(empty)
 SiteInspection(empty)
 Sae(empty)
 Ciom(empty)
 StudyRoute(empty)
 Manufacturer(empty)
 Reassignment(empty)
 Attachment(empty)
 AnnualApproval(empty)
 AmendmentChecklist(empty)
 Reminder(empty)
 ParticipantFlow(empty)
 Budget(empty)
 Deviation(empty)
 Document(empty)
 CoverLetter(empty)
 Protocol(empty)
 PatientLeaflet(empty)
 Brochure(empty)
 GmpCertificate(empty)
 Cv(empty)
 Finance(empty)
 Declaration(empty)
 IndemnityCover(empty)
 OpinionLetter(empty)
 ApprovalLetter(empty)
 Statement(empty)
 ParticipatingStudy(empty)
 Addendum(empty)
 Registration(empty)
 Fee(empty)
 Checklist(empty)
 StudyMonitor(empty)
 ProtocolOutsource(empty)
 Outsource(empty)
- Loaded Helpers(array)
 0Html
 1Form
 2Session
 3Text
 4Number
 5SimpleGraph
 6DebugTimer
 7Toolbar
 8HtmlToolbar
====

Environment

App Constants

Constant	Value
MEDIA	'/var/www/ctr/app/webroot/media/'
MEDIA_STATIC	'/var/www/ctr/app/webroot/media/static/'
MEDIA_FILTER	'/var/www/ctr/app/webroot/media/filter/'
MEDIA_TRANSFER	'/var/www/ctr/app/webroot/media/transfer/'
MEDIA_URL	'media/'
MEDIA_STATIC_URL	'media/static/'
MEDIA_FILTER_URL	'media/filter/'
MEDIA_TRANSFER_URL	'media/transfer/'
HTTP_HOST	'45.79.161.190:8080'
HTTP_BASE	'http://45.79.161.190:8080'
HTTP_SELF	'/app/webroot/index.php'
HTTP_URI	'/applications/view/124'
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=5ock7auq9pjmt44nec3vvta987'
Http Accept Encoding	'gzip, br, zstd, deflate'
Http Host	'45.79.161.190:8080'
Http Via	'1.1 squid-proxy-5b5d847c96-qq957 (squid/6.10)'
Http X Forwarded For	'10.3.82.253'
Http Cache Control	'max-age=259200'
Http Connection	'keep-alive'
Path	'/usr/local/sbin:/usr/local/bin:/usr/sbin:/usr/bin:/sbin:/bin:/snap/bin'
Server Signature	' Apache/2.4.29 (Ubuntu) Server at 45.79.161.190 Port 8080 '
Server Software	'Apache/2.4.29 (Ubuntu)'
Server Name	'45.79.161.190'
Server Addr	'45.79.161.190'
Server Port	'8080'
Remote Addr	'216.73.216.36'
Document Root	'/var/www/ctr'
Request Scheme	'http'
Context Prefix	''
Context Document Root	'/var/www/ctr'
Server Admin	'webmaster@localhost'
Script Filename	'/var/www/ctr/app/webroot/index.php'
Remote Port	'43492'
Redirect Url	'/app/webroot/applications/view/124'
Gateway Interface	'CGI/1.1'
Server Protocol	'HTTP/1.1'
Request Method	'GET'
Query String	''
Request Uri	'/applications/view/124'
Script Name	'/app/webroot/index.php'
Php Self	'/app/webroot/index.php'
Request Time Float	(float) 1756471542.38
Request Time	(int) 1756471542

====

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:	Testronimal Study Phase 2
Study Objectives:	test
Laymans Summary:	Layman SUmmary
Abstract of Study:	Testronimal Study Phase 2

Request History

Session

Request

Cake Params

Post data

Query string

Cookie

Current Route

Sql Logs

default

Total Time: 59 ms Total Queries: 53 queries

Query Explain:

Memory

Timers

Logs

View Variables

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

Included Files

Total Time: 59 ms
Total Queries: 53 queries