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• application(array)
  • Application(array)
    • id121
    • user_id29
    • application_id(null)
    • is_child0
    • trial_status_id10
    • total_sites4
    • abstract_of_study<p> Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p> <p> The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p> <p> Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>
    • study_title<p> Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p> <p> The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p> <p> Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>
    • laymans_summary<p> Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p> <p> The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p> <p> Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>
    • short_titleIusto obcaecati Nam dicta veli
    • protocol_noECCT/24/11/02
    • reference_no(null)
    • version_noConsectetur qui ipsam omnis eos et voluptas
    • date_of_protocol20-11-2015
    • study_drugEst esse ex reprehenderit aute laborum illo consectetur soluta atque dolor quia numquam odit delectus et aut placeat
    • disease_conditionEt officia qui consequuntur quisquam veritatis obcaecati sunt non sit dolorum quae
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    • product_type_chemical1
    • product_type_medical_device1
    • product_type_chemical_nameEagan Alston
    • product_type_medical_device_nameTanisha Rowland
    • comparatorYes
    • comparator_nameBrendan Blair
    • comparator_registeredAut enim quaerat consequatur s
    • comparator_countriesRerum quis ut veniam
    • ecct_not_applicable0
    • ecct_ref_number
    • email_addressjkiprotich@intellisoftkenya.com
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    • declaration_applicantSunt atque ipsum obcaecati commodo aspernatur fuga Voluptatem sed sequi cupidatat quo enim
    • declaration_date107-11-2024
    • declaration_principal_investigatorSit reprehenderit dicta beatae officia et magni deserunt ipsum in sint voluptates sed necessitatibus neque quis aspernatur esse ut
    • declaration_date214-11-2024
    • placebo_presentYes
    • study_objectives<p> Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p> <p> The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p> <p> Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>
    • principal_inclusion_criteria<p> Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p> <p> The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p> <p> Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>
    • principal_exclusion_criteria<p> Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p> <p> The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p> <p> Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>
    • primary_end_points<p> Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p> <p> The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p> <p> Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>
    • scope_diagnosis1
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    • scope_therapy1
    • scope_safety0
    • scope_efficacy1
    • scope_pharmacokinetic0
    • scope_pharmacodynamic0
    • scope_bioequivalence0
    • scope_dose_response0
    • scope_pharmacogenetic0
    • scope_pharmacogenomic1
    • scope_pharmacoecomomic0
    • scope_others1
    • scope_others_specifyLorem voluptatem Ab
    • trial_human_pharmacology1
    • trial_administration_humans1
    • trial_bioequivalence_study1
    • trial_other1
    • trial_other_specifySimilique tempore c
    • trial_therapeutic_exploratory1
    • trial_therapeutic_confirmatory1
    • trial_therapeutic_use1
    • design_controlledYes
    • site_capacity(null)
    • staff_numbers<p> Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p> <p> The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p> <p> Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>
    • other_details_explanation<p> Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p> <p> The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p> <p> Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>
    • other_details_regulatory_notapproved<p> Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p> <p> The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p> <p> Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>
    • other_details_regulatory_approved<p> Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p> <p> The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p> <p> Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>
    • other_details_regulatory_rejected<p> Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p> <p> The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p> <p> Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>
    • other_details_regulatory_halted<p> Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p> <p> The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p> <p> Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>
    • estimated_duration3
    • design_controlled_randomisedNo
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    • design_controlled_double_blindNo
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    • design_controlled_specifyEum labore saepe rem quia sint dolore porro magni nihil facilis doloribus sint ipsa et officia distinctio Aut
    • design_controlled_comparatorBlanditiis quaerat est ex
    • design_controlled_other_medicinalYes
    • design_controlled_placeboNo
    • design_controlled_medicinal_otherNo
    • design_controlled_medicinal_specify
    • single_site_member_stateNo
    • location_of_area
    • single_site_physical_address
    • single_site_contact_person
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    • multiple_sites_member_stateNo
    • multiple_countriesYes
    • multiple_member_states4
    • number_of_sites
    • multi_country_listHarum hic tempora ne
    • data_monitoring_committeeYes
    • total_enrolment_per_siteNon ex beatae a dele
    • total_participants_worldwideExcepteur maxime nisi voluptatem minim ad quisquam harum dolore doloribus quia sunt consequatur Perspiciatis doloribus sed
    • population_less_than_18_yearsYes
    • population_uteroNo
    • population_preterm_newbornYes
    • population_newbornYes
    • population_infant_and_toddlerNo
    • population_childrenNo
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    • population_adultNo
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    • gender_female1
    • gender_male0
    • subjects_healthyNo
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    • subjects_incapable_consentNo
    • subjects_specify
    • subjects_othersYes
    • subjects_others_specifyExercitation perspic
    • investigator1_given_nameRachel Hewitt
    • investigator1_middle_nameKylynn Townsend
    • investigator1_family_nameOctavia Acosta
    • investigator1_qualificationDolores quae ut corrupti voluptatem in aliquip animi esse aliqua Dicta sapiente ipsam debitis impedit nobis
    • investigator1_professional_addressVel aut quis in consectetur incidunt placeat sint consectetur sint dolores commodi
    • investigator1_telephone+1 (618) 138-4296
    • investigator1_emailbezic@mailinator.com
    • organisations_transferred_Yes
    • number_participantsSuscipit adipisicing
    • notification<p> Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p> <p> The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p> <p> Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>
    • approval_date29-11-2024
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    • date_submitted20-11-2024
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    • approved2
    • approved_reasonTest
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    • final_report<p> test sample</p>
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    • quantity_dispensed3
    • quantity_destroyed4
    • quantity_exported1
    • balance_site2
    • final_date2025-08-05
    • ecitizen_invoice324265
    • modified2025-08-05 08:08:23
    • created2024-10-18 08:02:13
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    • qualificationDentist
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    • name_of_institution
    • institution_physical
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    • county_id47
    • country_id115
    • group_id5
    • activation_key
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    • created2024-01-19 06:00:03
    • modified2024-10-16 14:11:49
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    • namePaused or preparation for extension of study
    • created2025-01-06 00:00:00
    • modified2025-01-06 00:00:00
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      • created2024-12-17 07:16:36
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      • summary1.1 Introduction Ipsum at in duis et Primary pharmacodynamics comments Velit dolores deseru Secondary pharmacodynamics comments Tempore dolor et ve Pharmacodynamic drug interactions comments Dolores est obcaeca Pharmacokinetics comments Porro deserunt natus Absorption, Distribution, Metabolism & Excretion comments Ipsam placeat magna Other pharmacokinetic studies comments Maxime fuga Eum ali Animal species selection/Study design comments Et architecto nostru Single dose toxicity comments Recusandae Elit vo Repeat-dose toxicity comments Optio voluptatem E Genotoxicity comments Aut excepteur commod Carcinogenicity comments Est vero reprehende Reproductive and developmental toxicity - comments Nisi asperiores duis Juvenile toxicity studies comments Nostrum sed ipsum ut Other studies (including enhanced PPND studies) comments Veniam nostrud debi Local tolerance comments Saepe debitis ipsam Other toxicity studies comments A natus sunt id ven Additional Considerations comments Dolorum molestiae vo GLP aspects comments Autem at velit labo Overall comment/ conclusion on the non-clinical assessment Ea velit sed quaerat
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      • created2024-12-17 07:30:23
      • modified2024-12-17 07:31:14
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      • summary1.1 Introduction Ipsum at in duis et Primary pharmacodynamics comments Velit dolores deseru Secondary pharmacodynamics comments Tempore dolor et ve Pharmacodynamic drug interactions comments Dolores est obcaeca Pharmacokinetics comments Porro deserunt natus Absorption, Distribution, Metabolism & Excretion comments Ipsam placeat magna Other pharmacokinetic studies comments Maxime fuga Eum ali Animal species selection/Study design comments Et architecto nostru Single dose toxicity comments Recusandae Elit vo Repeat-dose toxicity comments Optio voluptatem E Genotoxicity comments Aut excepteur commod Carcinogenicity comments Est vero reprehende Reproductive and developmental toxicity - comments Nisi asperiores duis Juvenile toxicity studies comments Nostrum sed ipsum ut Other studies (including enhanced PPND studies) comments Veniam nostrud debi Local tolerance comments Saepe debitis ipsam Other toxicity studies comments A natus sunt id ven Additional Considerations comments Dolorum molestiae vo GLP aspects comments Autem at velit labo Overall comment/ conclusion on the non-clinical assessment Ea velit sed quaerat
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      • applicant_opinion_letter(null)
      • applicant_approval_letter(null)
      • applicant_statement(null)
      • applicant_participating_countries(null)
      • applicant_addendum(null)
      • applicant_fees(null)
      • declaration_applicant
      • declaration_date1(null)
      • declaration_principal_investigator
      • declaration_date2(null)
      • placebo_present
      • study_objectives
      • principal_inclusion_criteria
      • principal_exclusion_criteria
      • primary_end_points
      • scope_diagnosis(null)
      • scope_prophylaxis(null)
      • scope_therapy(null)
      • scope_safety(null)
      • scope_efficacy(null)
      • scope_pharmacokinetic(null)
      • scope_pharmacodynamic(null)
      • scope_bioequivalence(null)
      • scope_dose_response(null)
      • scope_pharmacogenetic(null)
      • scope_pharmacogenomic(null)
      • scope_pharmacoecomomic(null)
      • scope_others(null)
      • scope_others_specify(null)
      • trial_human_pharmacology(null)
      • trial_administration_humans(null)
      • trial_bioequivalence_study(null)
      • trial_other(null)
      • trial_other_specify(null)
      • trial_therapeutic_exploratory(null)
      • trial_therapeutic_confirmatory(null)
      • trial_therapeutic_use(null)
      • design_controlled
      • site_capacity(null)
      • staff_numbers
      • other_details_explanation
      • other_details_regulatory_notapproved
      • other_details_regulatory_approved
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_duration
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_state
      • location_of_area
      • multiple_sites_member_state
      • multiple_countries
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committee
      • total_enrolment_per_site
      • total_participants_worldwide
      • population_less_than_18_years
      • population_utero
      • population_preterm_newborn
      • population_newborn
      • population_infant_and_toddler
      • population_children
      • population_adolescent
      • population_above_18
      • population_adult
      • population_elderly
      • gender_female(null)
      • gender_male(null)
      • subjects_healthy
      • subjects_patients
      • subjects_vulnerable_populations
      • subjects_women_child_bearing
      • subjects_women_using_contraception
      • subjects_pregnant_women
      • subjects_nursing_women
      • subjects_emergency_situation
      • subjects_incapable_consent
      • subjects_specify
      • subjects_others
      • subjects_others_specify
      • investigator1_given_name(null)
      • investigator1_middle_name(null)
      • investigator1_family_name(null)
      • investigator1_qualification(null)
      • investigator1_professional_address(null)
      • organisations_transferred_(null)
      • number_participants
      • notification
      • approval_date(null)
      • submitted1
      • date_submitted2024-11-29 09:49:42
      • modified2024-11-29 09:49:42
      • created2024-11-29 09:49:25
    • 1(array)
      • id17
      • application_id121
      • trial_status_id(null)
      • abstract_of_study
      • study_title<p> Next amendment here</p>
      • laymans_summary
      • protocol_no(null)
      • version_no
      • date_of_protocol(null)
      • study_drug
      • disease_condition
      • product_type(null)
      • product_type_biologicals(null)
      • product_type_proteins(null)
      • product_type_immunologicals(null)
      • product_type_vaccines(null)
      • product_type_hormones(null)
      • product_type_toxoid(null)
      • product_type_chemical(null)
      • product_type_medical_device(null)
      • product_type_chemical_name(null)
      • product_type_medical_device_name(null)
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • previous_dates(null)
      • coordinating_investigators
      • principal_investigators
      • pharmacist
      • sponsor_details
      • gender
      • details_of_sites
      • placebos
      • scopes
      • organizations
      • types_and_phases
      • ecct_not_applicable0
      • ecct_ref_number
      • email_address(null)
      • applicant_covering_letter(null)
      • applicant_protocol(null)
      • applicant_patient_information(null)
      • applicant_investigators_brochure(null)
      • applicant_investigators_cv(null)
      • applicant_signed_declaration(null)
      • applicant_financial_declaration(null)
      • applicant_gmp_certificate(null)
      • applicant_indemnity_cover(null)
      • applicant_opinion_letter(null)
      • applicant_approval_letter(null)
      • applicant_statement(null)
      • applicant_participating_countries(null)
      • applicant_addendum(null)
      • applicant_fees(null)
      • declaration_applicant
      • declaration_date1(null)
      • declaration_principal_investigator
      • declaration_date2(null)
      • placebo_present
      • study_objectives
      • principal_inclusion_criteria
      • principal_exclusion_criteria
      • primary_end_points
      • scope_diagnosis(null)
      • scope_prophylaxis(null)
      • scope_therapy(null)
      • scope_safety(null)
      • scope_efficacy(null)
      • scope_pharmacokinetic(null)
      • scope_pharmacodynamic(null)
      • scope_bioequivalence(null)
      • scope_dose_response(null)
      • scope_pharmacogenetic(null)
      • scope_pharmacogenomic(null)
      • scope_pharmacoecomomic(null)
      • scope_others(null)
      • scope_others_specify(null)
      • trial_human_pharmacology(null)
      • trial_administration_humans(null)
      • trial_bioequivalence_study(null)
      • trial_other(null)
      • trial_other_specify(null)
      • trial_therapeutic_exploratory(null)
      • trial_therapeutic_confirmatory(null)
      • trial_therapeutic_use(null)
      • design_controlled
      • site_capacity(null)
      • staff_numbers
      • other_details_explanation
      • other_details_regulatory_notapproved
      • other_details_regulatory_approved
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_duration
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_state
      • location_of_area
      • multiple_sites_member_state
      • multiple_countries
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committee
      • total_enrolment_per_site
      • total_participants_worldwide
      • population_less_than_18_years
      • population_utero
      • population_preterm_newborn
      • population_newborn
      • population_infant_and_toddler
      • population_children
      • population_adolescent
      • population_above_18
      • population_adult
      • population_elderly
      • gender_female(null)
      • gender_male(null)
      • subjects_healthy
      • subjects_patients
      • subjects_vulnerable_populations
      • subjects_women_child_bearing
      • subjects_women_using_contraception
      • subjects_pregnant_women
      • subjects_nursing_women
      • subjects_emergency_situation
      • subjects_incapable_consent
      • subjects_specify
      • subjects_others
      • subjects_others_specify
      • investigator1_given_name(null)
      • investigator1_middle_name(null)
      • investigator1_family_name(null)
      • investigator1_qualification(null)
      • investigator1_professional_address(null)
      • organisations_transferred_(null)
      • number_participants
      • notification
      • approval_date(null)
      • submitted1
      • date_submitted2024-11-29 09:50:05
      • modified2024-11-29 09:50:05
      • created2024-11-29 09:49:53
    • 2(array)
      • id18
      • application_id121
      • trial_status_id(null)
      • abstract_of_study
      • study_title<p> Next </p>
      • laymans_summary
      • protocol_no(null)
      • version_no
      • date_of_protocol(null)
      • study_drug
      • disease_condition
      • product_type(null)
      • product_type_biologicals(null)
      • product_type_proteins(null)
      • product_type_immunologicals(null)
      • product_type_vaccines(null)
      • product_type_hormones(null)
      • product_type_toxoid(null)
      • product_type_chemical(null)
      • product_type_medical_device(null)
      • product_type_chemical_name(null)
      • product_type_medical_device_name(null)
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • previous_dates(null)
      • coordinating_investigators
      • principal_investigators
      • pharmacist
      • sponsor_details
      • gender
      • details_of_sites
      • placebos
      • scopes
      • organizations
      • types_and_phases
      • ecct_not_applicable0
      • ecct_ref_number
      • email_address(null)
      • applicant_covering_letter(null)
      • applicant_protocol(null)
      • applicant_patient_information(null)
      • applicant_investigators_brochure(null)
      • applicant_investigators_cv(null)
      • applicant_signed_declaration(null)
      • applicant_financial_declaration(null)
      • applicant_gmp_certificate(null)
      • applicant_indemnity_cover(null)
      • applicant_opinion_letter(null)
      • applicant_approval_letter(null)
      • applicant_statement(null)
      • applicant_participating_countries(null)
      • applicant_addendum(null)
      • applicant_fees(null)
      • declaration_applicant
      • declaration_date1(null)
      • declaration_principal_investigator
      • declaration_date2(null)
      • placebo_present
      • study_objectives
      • principal_inclusion_criteria
      • principal_exclusion_criteria
      • primary_end_points
      • scope_diagnosis(null)
      • scope_prophylaxis(null)
      • scope_therapy(null)
      • scope_safety(null)
      • scope_efficacy(null)
      • scope_pharmacokinetic(null)
      • scope_pharmacodynamic(null)
      • scope_bioequivalence(null)
      • scope_dose_response(null)
      • scope_pharmacogenetic(null)
      • scope_pharmacogenomic(null)
      • scope_pharmacoecomomic(null)
      • scope_others(null)
      • scope_others_specify(null)
      • trial_human_pharmacology(null)
      • trial_administration_humans(null)
      • trial_bioequivalence_study(null)
      • trial_other(null)
      • trial_other_specify(null)
      • trial_therapeutic_exploratory(null)
      • trial_therapeutic_confirmatory(null)
      • trial_therapeutic_use(null)
      • design_controlled
      • site_capacity(null)
      • staff_numbers
      • other_details_explanation
      • other_details_regulatory_notapproved
      • other_details_regulatory_approved
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_duration
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_state
      • location_of_area
      • multiple_sites_member_state
      • multiple_countries
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committee
      • total_enrolment_per_site
      • total_participants_worldwide
      • population_less_than_18_years
      • population_utero
      • population_preterm_newborn
      • population_newborn
      • population_infant_and_toddler
      • population_children
      • population_adolescent
      • population_above_18
      • population_adult
      • population_elderly
      • gender_female(null)
      • gender_male(null)
      • subjects_healthy
      • subjects_patients
      • subjects_vulnerable_populations
      • subjects_women_child_bearing
      • subjects_women_using_contraception
      • subjects_pregnant_women
      • subjects_nursing_women
      • subjects_emergency_situation
      • subjects_incapable_consent
      • subjects_specify
      • subjects_others
      • subjects_others_specify
      • investigator1_given_name(null)
      • investigator1_middle_name(null)
      • investigator1_family_name(null)
      • investigator1_qualification(null)
      • investigator1_professional_address(null)
      • organisations_transferred_(null)
      • number_participants
      • notification
      • approval_date(null)
      • submitted1
      • date_submitted2024-11-29 09:51:35
      • modified2024-11-29 09:51:35
      • created2024-11-29 09:51:21
    • 3(array)
      • id19
      • application_id121
      • trial_status_id(null)
      • abstract_of_study
      • study_title
      • laymans_summary
      • protocol_no(null)
      • version_no
      • date_of_protocol(null)
      • study_drug
      • disease_condition
      • product_type(null)
      • product_type_biologicals(null)
      • product_type_proteins(null)
      • product_type_immunologicals(null)
      • product_type_vaccines(null)
      • product_type_hormones(null)
      • product_type_toxoid(null)
      • product_type_chemical(null)
      • product_type_medical_device(null)
      • product_type_chemical_name(null)
      • product_type_medical_device_name(null)
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • previous_dates(null)
      • coordinating_investigators
      • principal_investigators
      • pharmacist
      • sponsor_details
      • gender
      • details_of_sites
      • placebos
      • scopes
      • organizations
      • types_and_phases
      • ecct_not_applicable0
      • ecct_ref_number
      • email_address(null)
      • applicant_covering_letter(null)
      • applicant_protocol(null)
      • applicant_patient_information(null)
      • applicant_investigators_brochure(null)
      • applicant_investigators_cv(null)
      • applicant_signed_declaration(null)
      • applicant_financial_declaration(null)
      • applicant_gmp_certificate(null)
      • applicant_indemnity_cover(null)
      • applicant_opinion_letter(null)
      • applicant_approval_letter(null)
      • applicant_statement(null)
      • applicant_participating_countries(null)
      • applicant_addendum(null)
      • applicant_fees(null)
      • declaration_applicant
      • declaration_date1(null)
      • declaration_principal_investigator
      • declaration_date2(null)
      • placebo_present
      • study_objectives
      • principal_inclusion_criteria
      • principal_exclusion_criteria
      • primary_end_points
      • scope_diagnosis(null)
      • scope_prophylaxis(null)
      • scope_therapy(null)
      • scope_safety(null)
      • scope_efficacy(null)
      • scope_pharmacokinetic(null)
      • scope_pharmacodynamic(null)
      • scope_bioequivalence(null)
      • scope_dose_response(null)
      • scope_pharmacogenetic(null)
      • scope_pharmacogenomic(null)
      • scope_pharmacoecomomic(null)
      • scope_others(null)
      • scope_others_specify(null)
      • trial_human_pharmacology(null)
      • trial_administration_humans(null)
      • trial_bioequivalence_study(null)
      • trial_other(null)
      • trial_other_specify(null)
      • trial_therapeutic_exploratory(null)
      • trial_therapeutic_confirmatory(null)
      • trial_therapeutic_use(null)
      • design_controlled
      • site_capacity(null)
      • staff_numbers
      • other_details_explanation
      • other_details_regulatory_notapproved
      • other_details_regulatory_approved
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_duration
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_state
      • location_of_area
      • multiple_sites_member_state
      • multiple_countries
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committee
      • total_enrolment_per_site
      • total_participants_worldwide
      • population_less_than_18_years
      • population_utero
      • population_preterm_newborn
      • population_newborn
      • population_infant_and_toddler
      • population_children
      • population_adolescent
      • population_above_18
      • population_adult
      • population_elderly
      • gender_female(null)
      • gender_male(null)
      • subjects_healthy
      • subjects_patients
      • subjects_vulnerable_populations
      • subjects_women_child_bearing
      • subjects_women_using_contraception
      • subjects_pregnant_women
      • subjects_nursing_women
      • subjects_emergency_situation
      • subjects_incapable_consent
      • subjects_specify
      • subjects_others
      • subjects_others_specify
      • investigator1_given_name(null)
      • investigator1_middle_name(null)
      • investigator1_family_name(null)
      • investigator1_qualification(null)
      • investigator1_professional_address(null)
      • organisations_transferred_(null)
      • number_participants
      • notification
      • approval_date(null)
      • submitted1
      • date_submitted2024-11-29 10:03:41
      • modified2024-11-29 10:03:41
      • created2024-11-29 09:52:18
    • 4(array)
      • id20
      • application_id121
      • trial_status_id(null)
      • abstract_of_study
      • study_title
      • laymans_summary
      • protocol_no(null)
      • version_no
      • date_of_protocol(null)
      • study_drug
      • disease_condition
      • product_type(null)
      • product_type_biologicals(null)
      • product_type_proteins(null)
      • product_type_immunologicals(null)
      • product_type_vaccines(null)
      • product_type_hormones(null)
      • product_type_toxoid(null)
      • product_type_chemical(null)
      • product_type_medical_device(null)
      • product_type_chemical_name(null)
      • product_type_medical_device_name(null)
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • previous_dates(null)
      • coordinating_investigatorsKiprotich Japheth
      • principal_investigatorsAnother One
      • pharmacistComment Here
      • sponsor_details
      • gender
      • details_of_sites
      • placebos
      • scopes
      • organizations
      • types_and_phases
      • ecct_not_applicable0
      • ecct_ref_number
      • email_address(null)
      • applicant_covering_letter(null)
      • applicant_protocol(null)
      • applicant_patient_information(null)
      • applicant_investigators_brochure(null)
      • applicant_investigators_cv(null)
      • applicant_signed_declaration(null)
      • applicant_financial_declaration(null)
      • applicant_gmp_certificate(null)
      • applicant_indemnity_cover(null)
      • applicant_opinion_letter(null)
      • applicant_approval_letter(null)
      • applicant_statement(null)
      • applicant_participating_countries(null)
      • applicant_addendum(null)
      • applicant_fees(null)
      • declaration_applicant
      • declaration_date1(null)
      • declaration_principal_investigator
      • declaration_date2(null)
      • placebo_present
      • study_objectives
      • principal_inclusion_criteria
      • principal_exclusion_criteria
      • primary_end_points
      • scope_diagnosis(null)
      • scope_prophylaxis(null)
      • scope_therapy(null)
      • scope_safety(null)
      • scope_efficacy(null)
      • scope_pharmacokinetic(null)
      • scope_pharmacodynamic(null)
      • scope_bioequivalence(null)
      • scope_dose_response(null)
      • scope_pharmacogenetic(null)
      • scope_pharmacogenomic(null)
      • scope_pharmacoecomomic(null)
      • scope_others(null)
      • scope_others_specify(null)
      • trial_human_pharmacology(null)
      • trial_administration_humans(null)
      • trial_bioequivalence_study(null)
      • trial_other(null)
      • trial_other_specify(null)
      • trial_therapeutic_exploratory(null)
      • trial_therapeutic_confirmatory(null)
      • trial_therapeutic_use(null)
      • design_controlled
      • site_capacity(null)
      • staff_numbers
      • other_details_explanation
      • other_details_regulatory_notapproved
      • other_details_regulatory_approved
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_duration
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_state
      • location_of_area
      • multiple_sites_member_state
      • multiple_countries
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committee
      • total_enrolment_per_site
      • total_participants_worldwide
      • population_less_than_18_years
      • population_utero
      • population_preterm_newborn
      • population_newborn
      • population_infant_and_toddler
      • population_children
      • population_adolescent
      • population_above_18
      • population_adult
      • population_elderly
      • gender_female(null)
      • gender_male(null)
      • subjects_healthy
      • subjects_patients
      • subjects_vulnerable_populations
      • subjects_women_child_bearing
      • subjects_women_using_contraception
      • subjects_pregnant_women
      • subjects_nursing_women
      • subjects_emergency_situation
      • subjects_incapable_consent
      • subjects_specify
      • subjects_others
      • subjects_others_specify
      • investigator1_given_name(null)
      • investigator1_middle_name(null)
      • investigator1_family_name(null)
      • investigator1_qualification(null)
      • investigator1_professional_address(null)
      • organisations_transferred_(null)
      • number_participants
      • notification
      • approval_date(null)
      • submitted1
      • date_submitted2024-11-29 10:04:21
      • modified2024-11-29 10:04:21
      • created2024-11-29 10:03:51
    • 5(array)
      • id21
      • application_id121
      • trial_status_id(null)
      • abstract_of_study
      • study_title
      • laymans_summary
      • protocol_no(null)
      • version_no
      • date_of_protocol(null)
      • study_drug
      • disease_condition
      • product_type(null)
      • product_type_biologicals(null)
      • product_type_proteins(null)
      • product_type_immunologicals(null)
      • product_type_vaccines(null)
      • product_type_hormones(null)
      • product_type_toxoid(null)
      • product_type_chemical(null)
      • product_type_medical_device(null)
      • product_type_chemical_name(null)
      • product_type_medical_device_name(null)
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      • content<h3 style="text-align: center;"> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><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" /></span></span></h3> <p style="text-align: center;"> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><strong>MINISTRY</strong> <strong>OF</strong> <strong>HEALTH</strong></span></span></p> <p style="text-align: center;"> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><strong>PHARMACY</strong> <strong>AND</strong> <strong>POISONS</strong> <strong>BOARD</strong></span></span></p> <table style="width: 100%; border:0px"> <tbody> <tr> <td style="width: 33.33%; border:0px"> <div id="left-editor"> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">Telegram: "MINHEALTH", Nairobi</span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">Cell phone: 0709 770 100</span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">Email: info@pharmacyboardkenya.org</span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">Website: web.pharmacyboardkenya.org</span></span></p> </div> </td> <td style="width: 33.33%;border:0px">  </td> <td style="width: 33.33%;border:0px"> <div id="right-editor"> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">Pharmacy and Poisons Board House</span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">Along Lenana Road </span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">P.O. Box 27663-00506 </span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">NAIROBI </span></span></p> </div> </td> </tr> </tbody> </table> <address> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"> </span></span></address> <address> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">When replying please quote</span></span></address> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><strong>Ref.</strong> <strong>No.</strong> <strong>ECCT/1/2024-ECCT/24/11/02                                                                                                                                                                             17 Dec 2024</strong></span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><strong>Linus Sexton Ori Hill Jacob Mckay,</strong></span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><strong>Principal</strong> <strong>Investigator</strong> <strong>ECCT/24/11/02,</strong></span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><strong>Aliquam fugiat qui officia veniam excepturi et nisi neque enim aliquip tempora,</strong></span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">Dear Sir/Madam,</span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><strong><u>Re: ECCT/24/11/02 : Annual Approval; </u></strong></span></span></p> <p> <strong><u>Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</u></strong></p> <p> <strong><u>The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</u></strong></p> <p> <strong><u>Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</u></strong></p> <p> <strong><u>  Iusto obcaecati Nam dicta veli</u></strong><strong style="font-family: "bookman old style", serif;"><u>.</u></strong></p> <p>  </p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">Reference is made to the above study.</span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">We acknowledge receipt of the following documents;</span></span></p> <div style="margin-left: 15px;"> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">1. Cover Letter (Should list all the submitted documents, their version numbers and dates)<br /> <a href="/attachments/download/1072">screenshot_from_2024_11_28_11_17_15_2.png</a> dated 29th November 2024 Version 6<br /> 2. Annual progress report<br /> <a href="/attachments/download/1100">logo_28.png</a> dated 2nd December 2024 Version 1<br /> 3. SAE and SUSAR cumulative logs<br /> <a href="/attachments/download/1101">logo_29.png</a> dated 25th November 2024 Version 2<br /> 4. A signed checklist confirming the submission of the document<br /> <a href="/attachments/download/1102">logo_30.png</a> dated 19th December 2024 Version 4<br /> 5. Evidence of registration of the study at Pan African Clinical Trials Registry https://pactr.samrc.ac.za<br /> <a href="/attachments/download/1103">logo_31.png</a> dated 2nd December 2024 Version 3<br /> 6. Copy of valid participants’ clinical trials insurance cover<br /> <a href="/attachments/download/1104">logo_32.png</a> dated 3rd December 2024 Version 2<br /> 7. Copy of the valid professional indemnity insurance cover for the study pharmacist<br /> <a href="/attachments/download/1105">logo_33.png</a> dated 2nd December 2024 Version 4<br /> 8. Copy of the valid professional indemnity insurance cover for the investigators<br /> <a href="/attachments/download/1106">logo_34.png</a> dated 2nd December 2024 Version 3<br /> 9. Copy of the Annual Practice License for the Pharmacist<br /> <a href="/attachments/download/1107">logo_35.png</a> dated 2nd December 2024 Version 2<br /> 10. Copy of the Annual Practice License of the Investigators<br /> <a href="/attachments/download/1108">logo_36.png</a> dated 2nd December 2024 Version 2<br /> 11. Copy of current favourable opinion letter from the local Ethics Review Committee (ERC).<br /> <a href="/attachments/download/1109">logo_37.png</a> dated 2nd December 2024 Version 1<br /> 12. The Development Safety Update Report (DSUR)<br /> <a href="/attachments/download/1110">logo_38.png</a> dated 9th December 2024 Version 1<br /> 13. Updated Investigators Brochure/Package inserts or Investigational Medicinal Product Dossier (IMPD)<br /> <a href="/attachments/download/1111">logo_39.png</a> dated 25th November 2024 Version 1<br /> 14. Protocol Violations and Protocol Deviations logs<br /> <a href="/attachments/download/1112">logo_40.png</a> dated 2nd December 2024 Version 1<br /> 15. Latest Data Safety Monitoring Board (DSMB) report<br /> <a href="/attachments/download/1113">logo_41.png</a> dated 2nd December 2024 Version 1</span></span></div> <p> <span style="font-size:12px;">After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials notes the following:</span></p> <p> <span style="font-size:12px;">       </span></p> <p> <span style="font-size:12px;">The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study: </span></p> <p> Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p> <p> The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p> <p> Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p> <p> ECCT/24/11/02<strong>.</strong></p> <p>  </p> <p> <span style="font-size:12px;">This approval is <strong>valid</strong> <strong>for</strong> <strong>one</strong> <strong>year</strong> 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 <b>17th December 2025</b></span></p> <ol> <li> <span style="font-size:12px;">You should ensure compliance with Kenya Legal, regulatory and GCP requirements</span></li> <li> <span style="font-size:12px;">All safety reports should be submitted to ECCT as per the current PPB clinical trials guidelines</span></li> <li> <span style="font-size:12px;">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</span></li> <li> <span style="font-size:12px;">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</span></li> </ol> <div> <p> <span style="font-size:12px;">Yours Sincerely,</span></p> </div> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">:signature</span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">:approver</span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><strong><u>For Chief Executive Officer</u></strong></span></span></p> <p>  </p>
      • 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      • approvermanager
      • approval_date17-12-2024
      • expiry_date17-12-2025
      • statussubmitted
      • deleted0
      • deleted_date(null)
      • created2024-12-17 07:14:38
      • modified2024-12-17 07:15:03
    • 1(array)
      • id9
      • application_id121
      • approval_noECCT/2/2024-ECCT/24/11/02
      • type0
      • content<h3 style="text-align: center;"> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><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" /></span></span></h3> <p style="text-align: center;"> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><strong>MINISTRY</strong> <strong>OF</strong> <strong>HEALTH</strong></span></span></p> <p style="text-align: center;"> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><strong>PHARMACY</strong> <strong>AND</strong> <strong>POISONS</strong> <strong>BOARD</strong></span></span></p> <table style="width: 100%; border:0px"> <tbody> <tr> <td style="width: 33.33%; border:0px"> <div id="left-editor"> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">Telegram: "MINHEALTH", Nairobi</span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">Cell phone: 0709 770 100</span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">Email: info@pharmacyboardkenya.org</span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">Website: web.pharmacyboardkenya.org</span></span></p> </div> </td> <td style="width: 33.33%;border:0px">  </td> <td style="width: 33.33%;border:0px"> <div id="right-editor"> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">Pharmacy and Poisons Board House</span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">Along Lenana Road </span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">P.O. Box 27663-00506 </span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">NAIROBI </span></span></p> </div> </td> </tr> </tbody> </table> <address> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"> </span></span></address> <address> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">When replying please quote</span></span></address> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><strong>Ref.</strong> <strong>No.</strong> <strong>ECCT/2/2024-ECCT/24/11/02                                                                                                                                                                             17 Dec 2024</strong></span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><strong>Linus Sexton Ori Hill Jacob Mckay,</strong></span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><strong>Principal</strong> <strong>Investigator</strong> <strong>ECCT/24/11/02,</strong></span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><strong>Aliquam fugiat qui officia veniam excepturi et nisi neque enim aliquip tempora,</strong></span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">Dear Sir/Madam,</span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><strong><u>Re: ECCT/24/11/02 : Initial Approval; </u></strong></span></span></p> <p> <strong><u>Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</u></strong></p> <p> <strong><u>The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</u></strong></p> <p> <strong><u>Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</u></strong></p> <p> <strong><u>  Iusto obcaecati Nam dicta veli</u></strong><strong style="font-family: "bookman old style", serif;"><u>.</u></strong></p> <p>  </p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">Reference is made to the above study.</span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">We acknowledge receipt of the following documents;</span></span></p> <div style="margin-left: 15px;"> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">1. Cover Letter (Should list all the submitted documents, their version numbers and dates)<br /> <a href="/attachments/download/1042">screenshot_from_2024_11_20_08_51_47.png</a> dated 1st November 2024 Version 3<br /> 2. The Study Protocol<br /> <a href="/attachments/download/1043">screenshot_from_2024_11_20_08_51_47_2.png</a> dated 2nd November 2024 Version 3<br /> <a href="/attachments/download/1044">screenshot_from_2024_11_20_08_51_47_3.png</a> dated 7th November 2024 Version 3<br /> 3. Registration of the study at Pan African Clinical Trials Registry https://pactr.samrc.ac.za<br /> <a href="/attachments/download/1045">screenshot_from_2024_11_20_08_51_47_4.png</a> dated 3rd November 2024 Version 3<br /> 4. Patient Information leaflet and Informed consent form<br /> <a href="/attachments/download/1046">screenshot_from_2024_11_20_08_51_47_5.png</a> dated 4th November 2024 Version 3<br /> 5. Investigators Brochure/Package inserts<br /> <a href="/attachments/download/1047">screenshot_from_2024_11_20_08_51_47_6.png</a> dated 5th November 2024 Version 3<br /> 6. Investigational Medicinal Product Dossier (IMPD)<br /> <a href="/attachments/download/1048">screenshot_from_2024_11_20_08_51_47_7.png</a> dated 7th November 2024 Version 3<br /> 7. Adequate data and information from previous studies and Phases to support carrying out of the current study<br /> <a href="/attachments/download/1049">screenshot_from_2024_11_20_08_51_47_8.png</a> dated 7th November 2024 Version 3<br /> 8. Stability data of the investigational product<br /> <a href="/attachments/download/1050">screenshot_from_2024_11_20_08_51_47_9.png</a> dated 9th November 2024 Version 3<br /> 9. GMP certificate of the investigational product from the site of manufacture<br /> <a href="/attachments/download/1051">screenshot_from_2024_11_20_08_51_47_10.png</a> dated 7th November 2024 Version 3<br /> 10. Certificate of Analysis of the investigational product<br /> <a href="/attachments/download/1052">screenshot_from_2024_11_20_08_51_47_11.png</a> dated 9th November 2024 Version 3<br /> 11. Pictorial Sample of the investigational products. This sample should include the text of the labeling to be used<br /> <a href="/attachments/download/1053">screenshot_from_2024_11_20_08_51_47_12.png</a> dated 20th November 2024 Version 3<br /> 12. Signed investigator(s) CV(s) including that of study Pharmacist (NB: The CV should include the current workload of the Principal Investigator )<br /> <a href="/attachments/download/1054">screenshot_from_2024_11_20_08_51_47_13.png</a> dated 14th November 2024 Version 3<br /> 13. Evidence of contractual agreement between sponsor and Principal Investigator.<br /> <a href="/attachments/download/1055">screenshot_from_2024_11_20_08_51_47_14.png</a> dated 7th November 2024 Version 3<br /> 14. Evidence of recent GCP training of the core study staff<br /> <a href="/attachments/download/1056">screenshot_from_2024_11_20_08_51_47_15.png</a> dated 7th November 2024 Version 4<br /> 15. DSMB Charter including the composition and meeting schedule<br /> <a href="/attachments/download/1057">screenshot_from_2024_11_20_08_51_47_16.png</a> dated 7th November 2024 Version 4<br /> 16. Detailed budget of the study<br /> <a href="/attachments/download/1058">screenshot_from_2024_11_20_08_51_47_17.png</a> dated 13th November 2024 Version 4<br /> 17. Financial declaration by Sponsor and/or PI<br /> <a href="/attachments/download/1059">screenshot_from_2024_11_20_08_51_47_18.png</a> dated 6th November 2024 Version 4<br /> 18. Signed Declaration by Sponsor or Principal investigator that the study will be carried out according to the protocol and applicable laws, regulations and GCP requirements.<br /> <a href="/attachments/download/1060">screenshot_from_2024_11_20_08_51_47_19.png</a> dated 14th November 2024 Version 4<br /> 19. Indemnity cover for PI, investigators and study Pharmacist.<br /> <a href="/attachments/download/1061">screenshot_from_2024_11_20_08_51_47_20.png</a> dated 11th November 2024 Version 4<br /> 20. Clinical Trials Insurance cover for study participants<br /> <a href="/attachments/download/1062">screenshot_from_2024_11_20_08_51_47_21.png</a> dated 5th November 2024 Version 4<br /> 21. Copy of favorable opinion letter from the local Ethics Review Committee (ERC).<br /> <a href="/attachments/download/1063">screenshot_from_2024_11_20_08_51_47_22.png</a> dated 5th November 2024 Version 4<br /> 22. Copy of current Practice Licenses for the Investigators and study Pharmacist<br /> <a href="/attachments/download/1064">screenshot_from_2024_11_20_08_51_47_23.png</a> dated 12th November 2024 Version 4<br /> 23. Copy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable<br /> <a href="/attachments/download/1065">screenshot_from_2024_11_20_08_51_47_24.png</a> dated 6th November 2024 Version 4<br /> 24. For multicentre/multi-site studies, a site specific addendum for each of the proposed sites including among other things the sites’ capacity to carry out the study i.e personnel, equipment, laboratory etc<br /> <a href="/attachments/download/1066">screenshot_from_2024_11_20_08_51_47_25.png</a> dated 4th November 2024 Version 4<br /> 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.<br /> <a href="/attachments/download/1067">screenshot_from_2024_11_20_08_51_47_26.png</a> dated 12th November 2024 Version 4<br /> 26. Payment of fees<br /> <a href="/attachments/download/1068">screenshot_from_2024_11_20_08_51_47_27.png</a> dated 11th November 2024 Version 4<br /> 27. Statistical Analysis Plan<br /> <a href="/attachments/download/1069">screenshot_from_2024_11_20_08_51_47_28.png</a> dated 11th November 2024 Version 4<br /> 28. Signed Checklist<br /> <a href="/attachments/download/1070">screenshot_from_2024_11_20_08_51_47_29.png</a> dated 11th November 2024 Version 4</span></span></div> <p> <span style="font-size:12px;">After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials notes the following:</span></p> <p> <span style="font-size:12px;"><strong>     </strong></span></p> <p> <span style="font-size:12px;">The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study: </span></p> <p> Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p> <p> The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p> <p> Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p> <p> ECCT/24/11/02<strong>.</strong></p> <p>  </p> <p> <span style="font-size:12px;">This approval is <strong>valid</strong> <strong>for</strong> <strong>one</strong> <strong>year</strong> 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 <b>29th November 2025</b></span></p> <ol> <li> <span style="font-size:12px;">You should ensure compliance with Kenya Legal, regulatory and GCP requirements</span></li> <li> <span style="font-size:12px;">All safety reports should be submitted to ECCT as per the current PPB clinical trials guidelines</span></li> <li> <span style="font-size:12px;">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</span></li> <li> <span style="font-size:12px;">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</span></li> </ol> <div> <p> <span style="font-size:12px;">Yours Sincerely,</span></p> </div> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">:signature</span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">:approver</span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><strong><u>For Chief Executive Officer</u></strong></span></span></p> <p>  </p>
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
      • approvermanager
      • approval_date17-12-2024
      • expiry_date17-12-2025
      • statusapproved
      • deleted0
      • deleted_date(null)
      • created2024-12-17 07:15:18
      • modified2024-12-17 07:15:44
    • 2(array)
      • id66
      • application_id121
      • approval_noECCT/3/2024-ECCT/24/11/02
      • type0
      • content<h3 style="text-align: center;"> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><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" /></span></span></h3> <p style="text-align: center;"> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><strong>MINISTRY</strong> <strong>OF</strong> <strong>HEALTH</strong></span></span></p> <p style="text-align: center;"> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><strong>PHARMACY</strong> <strong>AND</strong> <strong>POISONS</strong> <strong>BOARD</strong></span></span></p> <table style="width: 100%; border:0px"> <tbody> <tr> <td style="width: 33.33%; border:0px"> <div id="left-editor"> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">Telegram: "MINHEALTH", Nairobi</span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">Cell phone: 0709 770 100</span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">Email: info@pharmacyboardkenya.org</span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">Website: web.pharmacyboardkenya.org</span></span></p> </div> </td> <td style="width: 33.33%;border:0px">  </td> <td style="width: 33.33%;border:0px"> <div id="right-editor"> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">Pharmacy and Poisons Board House</span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">Along Lenana Road </span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">P.O. Box 27663-00506 </span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">NAIROBI </span></span></p> </div> </td> </tr> </tbody> </table> <address> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"> </span></span></address> <address> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">When replying please quote</span></span></address> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><strong>Ref.</strong> <strong>No.</strong> <strong>ECCT/3/2024-ECCT/24/11/02                                                                                                                                                                             14 Jan 2025</strong></span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><strong>Linus Sexton Ori Hill Jacob Mckay,</strong></span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><strong>Principal</strong> <strong>Investigator</strong> <strong>ECCT/24/11/02,</strong></span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><strong>Aliquam fugiat qui officia veniam excepturi et nisi neque enim aliquip tempora,</strong></span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">Dear Sir/Madam,</span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><strong><u>Re: ECCT/24/11/02 : Initial Approval; </u></strong></span></span></p> <p> <strong><u>Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</u></strong></p> <p> <strong><u>The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</u></strong></p> <p> <strong><u>Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</u></strong></p> <p> <strong><u>  Iusto obcaecati Nam dicta veli</u></strong><strong style="font-family: "bookman old style", serif;"><u>.</u></strong></p> <p>  </p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">Reference is made to the above study.</span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">We acknowledge receipt of the following documents;</span></span></p> <div style="margin-left: 15px;"> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">1. Cover Letter (Should list all the submitted documents, their version numbers and dates)<br /> <a href="/attachments/download/1042">screenshot_from_2024_11_20_08_51_47.png</a> dated dated: 1st November 2024 Version 3<br /> 2. The Study Protocol<br /> <a href="/attachments/download/1043">screenshot_from_2024_11_20_08_51_47_2.png</a> dated dated: 2nd November 2024 Version 3<br /> <a href="/attachments/download/1044">screenshot_from_2024_11_20_08_51_47_3.png</a> dated dated: 7th November 2024 Version 3<br /> 3. Registration of the study at Pan African Clinical Trials Registry https://pactr.samrc.ac.za<br /> <a href="/attachments/download/1045">screenshot_from_2024_11_20_08_51_47_4.png</a> dated dated: 3rd November 2024 Version 3<br /> 4. Patient Information leaflet and Informed consent form<br /> <a href="/attachments/download/1046">screenshot_from_2024_11_20_08_51_47_5.png</a> dated dated: 4th November 2024 Version 3<br /> 5. Investigators Brochure/Package inserts<br /> <a href="/attachments/download/1047">screenshot_from_2024_11_20_08_51_47_6.png</a> dated dated: 5th November 2024 Version 3<br /> 6. Investigational Medicinal Product Dossier (IMPD)<br /> <a href="/attachments/download/1048">screenshot_from_2024_11_20_08_51_47_7.png</a> dated dated: 7th November 2024 Version 3<br /> 7. Adequate data and information from previous studies and Phases to support carrying out of the current study<br /> <a href="/attachments/download/1049">screenshot_from_2024_11_20_08_51_47_8.png</a> dated dated: 7th November 2024 Version 3<br /> 8. Stability data of the investigational product<br /> <a href="/attachments/download/1050">screenshot_from_2024_11_20_08_51_47_9.png</a> dated dated: 9th November 2024 Version 3<br /> 9. GMP certificate of the investigational product from the site of manufacture<br /> <a href="/attachments/download/1051">screenshot_from_2024_11_20_08_51_47_10.png</a> dated dated: 7th November 2024 Version 3<br /> 10. Certificate of Analysis of the investigational product<br /> <a href="/attachments/download/1052">screenshot_from_2024_11_20_08_51_47_11.png</a> dated dated: 9th November 2024 Version 3<br /> 11. Pictorial Sample of the investigational products. This sample should include the text of the labeling to be used<br /> <a href="/attachments/download/1053">screenshot_from_2024_11_20_08_51_47_12.png</a> dated dated: 20th November 2024 Version 3<br /> 12. Signed investigator(s) CV(s) including that of study Pharmacist (NB: The CV should include the current workload of the Principal Investigator )<br /> <a href="/attachments/download/1054">screenshot_from_2024_11_20_08_51_47_13.png</a> dated dated: 14th November 2024 Version 3<br /> 13. Evidence of contractual agreement between sponsor and Principal Investigator.<br /> <a href="/attachments/download/1055">screenshot_from_2024_11_20_08_51_47_14.png</a> dated dated: 7th November 2024 Version 3<br /> 14. Evidence of recent GCP training of the core study staff<br /> <a href="/attachments/download/1056">screenshot_from_2024_11_20_08_51_47_15.png</a> dated dated: 7th November 2024 Version 4<br /> 15. DSMB Charter including the composition and meeting schedule<br /> <a href="/attachments/download/1057">screenshot_from_2024_11_20_08_51_47_16.png</a> dated dated: 7th November 2024 Version 4<br /> 16. Detailed budget of the study<br /> <a href="/attachments/download/1058">screenshot_from_2024_11_20_08_51_47_17.png</a> dated dated: 13th November 2024 Version 4<br /> 17. Financial declaration by Sponsor and/or PI<br /> <a href="/attachments/download/1059">screenshot_from_2024_11_20_08_51_47_18.png</a> dated dated: 6th November 2024 Version 4<br /> 18. Signed Declaration by Sponsor or Principal investigator that the study will be carried out according to the protocol and applicable laws, regulations and GCP requirements.<br /> <a href="/attachments/download/1060">screenshot_from_2024_11_20_08_51_47_19.png</a> dated dated: 14th November 2024 Version 4<br /> 19. Indemnity cover for PI, investigators and study Pharmacist.<br /> <a href="/attachments/download/1061">screenshot_from_2024_11_20_08_51_47_20.png</a> dated dated: 11th November 2024 Version 4<br /> 20. Clinical Trials Insurance cover for study participants<br /> <a href="/attachments/download/1062">screenshot_from_2024_11_20_08_51_47_21.png</a> dated dated: 5th November 2024 Version 4<br /> 21. Copy of favorable opinion letter from the local Ethics Review Committee (ERC).<br /> <a href="/attachments/download/1063">screenshot_from_2024_11_20_08_51_47_22.png</a> dated dated: 5th November 2024 Version 4<br /> 22. Copy of current Practice Licenses for the Investigators and study Pharmacist<br /> <a href="/attachments/download/1064">screenshot_from_2024_11_20_08_51_47_23.png</a> dated dated: 12th November 2024 Version 4<br /> 23. Copy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable<br /> <a href="/attachments/download/1065">screenshot_from_2024_11_20_08_51_47_24.png</a> dated dated: 6th November 2024 Version 4<br /> 24. For multicentre/multi-site studies, a site specific addendum for each of the proposed sites including among other things the sites’ capacity to carry out the study i.e personnel, equipment, laboratory etc<br /> <a href="/attachments/download/1066">screenshot_from_2024_11_20_08_51_47_25.png</a> dated dated: 4th November 2024 Version 4<br /> 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.<br /> <a href="/attachments/download/1067">screenshot_from_2024_11_20_08_51_47_26.png</a> dated dated: 12th November 2024 Version 4<br /> 26. Payment of fees<br /> <a href="/attachments/download/1068">screenshot_from_2024_11_20_08_51_47_27.png</a> dated dated: 11th November 2024 Version 4<br /> 27. Statistical Analysis Plan<br /> <a href="/attachments/download/1069">screenshot_from_2024_11_20_08_51_47_28.png</a> dated dated: 11th November 2024 Version 4<br /> 28. Signed Checklist<br /> <a href="/attachments/download/1070">screenshot_from_2024_11_20_08_51_47_29.png</a> dated dated: 11th November 2024 Version 4</span></span></div> <p> <span style="font-size:12px;">After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials notes the following:</span></p> <p> <span style="font-size:12px;"><strong>        1.1 Introduction Ipsum at in duis et Primary pharmacodynamics comments Velit dolores deseru Secondary pharmacodynamics comments Tempore dolor et ve Pharmacodynamic drug interactions comments Dolores est obcaeca Pharmacokinetics comments Porro deserunt natus Absorption, Distribution, Metabolism & Excretion comments Ipsam placeat magna Other pharmacokinetic studies comments Maxime fuga Eum ali Animal species selection/Study design comments Et architecto nostru Single dose toxicity comments Recusandae Elit vo Repeat-dose toxicity comments Optio voluptatem E Genotoxicity comments Aut excepteur commod Carcinogenicity comments Est vero reprehende Reproductive and developmental toxicity - comments Nisi asperiores duis Juvenile toxicity studies comments Nostrum sed ipsum ut Other studies (including enhanced PPND studies) comments Veniam nostrud debi Local tolerance comments Saepe debitis ipsam Other toxicity studies comments A natus sunt id ven Additional Considerations comments Dolorum molestiae vo GLP aspects comments Autem at velit labo Overall comment/ conclusion on the non-clinical assessment Ea velit sed quaerat </strong></span></p> <p> <span style="font-size:12px;">The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study: </span></p> <p> Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p> <p> The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p> <p> Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p> <p> ECCT/24/11/02<strong>.</strong></p> <p>  </p> <p> <span style="font-size:12px;">This approval is <strong>valid</strong> <strong>for</strong> <strong>one</strong> <strong>year</strong> 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 <b>29th November 2025</b></span></p> <ol> <li> <span style="font-size:12px;">You should ensure compliance with Kenya Legal, regulatory and GCP requirements</span></li> <li> <span style="font-size:12px;">All safety reports should be submitted to ECCT as per the current PPB clinical trials guidelines</span></li> <li> <span style="font-size:12px;">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</span></li> <li> <span style="font-size:12px;">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</span></li> </ol> <div> <p> <span style="font-size:12px;">Yours Sincerely,</span></p> </div> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">:signature</span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;">:approver</span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><strong><u>For Chief Executive Officer</u></strong></span></span></p> <p>  </p>
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      • addressAutem odio eaque quia est blanditiis reiciendis commodi et adipisicing enim voluptate
      • telephone_number+1 (343) 625-7251
      • fax_number+1 (936) 324-2944
      • cell_number+1 (942) 698-1737
      • email_addressvugit@mailinator.com
      • created2024-11-20 09:47:01
      • modified2024-11-20 10:15:06
  • SiteInspection(empty)
  • Sae(array)
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      • form_typeSAE
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      • reporter_emailjkiprotich@intellisoftkenya.com
      • deleted0
      • deleted_date(null)
      • created2024-12-04 14:46:22
      • modified2024-12-04 14:46:22
    • 1(array)
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      • deleted0
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      • created2024-12-04 17:04:03
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      • created2024-12-10 16:14:22
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      • reporter_emailjkiprotich@intellisoftkenya.com
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      • created2024-12-16 07:21:03
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      • reporter_emailjkiprotich@intellisoftkenya.com
      • deleted0
      • deleted_date(null)
      • created2024-12-16 07:21:18
      • modified2024-12-16 07:21:18
    • 5(array)
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      • sae_id(null)
      • reference_noSUSAR/2024/04
      • form_typeSUSAR
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      • deleted0
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      • created2024-12-16 07:21:42
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  • Ciom(array)
    • 0(array)
      • id16
      • application_id121
      • reference_no(null)
      • user_id29
      • reporter_emailjkiprotich@intellisoftkenya.com
      • e2b_content<?xml version="1.0" encoding="ISO-8859-1"?> <!DOCTYPE ichicsr SYSTEM "http://eudravigilance.ema.europa.eu/dtd/icsr21xml.dtd"> <ichicsr lang="en"> <ichicsrmessageheader lang="en"> <messagetype>ichicsr</messagetype> <messageformatversion>2.1</messageformatversion> <messageformatrelease>2.0</messageformatrelease> <messagenumb>KE-PPB-2024-761</messagenumb> <messagesenderidentifier>PPB</messagesenderidentifier> <messagereceiveridentifier>KE</messagereceiveridentifier> <messagedateformat>204</messagedateformat> <messagedate>20241129122630</messagedate> </ichicsrmessageheader> <safetyreport lang="en"> <safetyreportversion>1</safetyreportversion> <safetyreportid>KE-PPB-SADR/2024/219</safetyreportid> <primarysourcecountry>KE</primarysourcecountry> <occurcountry>KE</occurcountry> <transmissiondateformat/> <transmissiondate/> <reporttype>1</reporttype> <serious>1</serious> <seriousnessdeath>2</seriousnessdeath> <seriousnesslifethreatening>1</seriousnesslifethreatening> <seriousnesshospitalization>2</seriousnesshospitalization> <seriousnessdisabling>2</seriousnessdisabling> <seriousnesscongenitalanomali>2</seriousnesscongenitalanomali> <seriousnessother>2</seriousnessother> <receivedateformat>102</receivedateformat> <receivedate>20241115</receivedate> <receiptdateformat>102</receiptdateformat> <receiptdate>20241115</receiptdate> <additionaldocument>2</additionaldocument> <documentlist></documentlist> <fulfillexpeditecriteria>1</fulfillexpeditecriteria> <authoritynumb>KE-PPB-SADR/2024/219</authoritynumb> <companynumb/> <duplicate>0</duplicate> <casenullification>0</casenullification> <nullificationreason/> <medicallyconfirm>1</medicallyconfirm> <primarysource> <reportergivename>Wilson</reportergivename> <reporterfamilyname></reporterfamilyname> <reporterorganization>Goodlife Pharmacy-Waterfront</reporterorganization> <reporterdepartment/> <reporterstreet>0737028576</reporterstreet> <reportercity/> <reporterstate/> <reporterpostcode/> <reportercountry>KE</reportercountry> <qualification>3</qualification> <literaturereference/> <studyname/> <sponsorstudynumb/> <observestudytype/> </primarysource> <sender> <sendertype>3</sendertype> <senderorganization>Pharmacy and Poisons Board</senderorganization> <senderdepartment>Department of Pharmacovigilance</senderdepartment> <sendertitle>Dr.</sendertitle> <sendergivename>Christabel</sendergivename> <sendermiddlename>N.</sendermiddlename> <senderfamilyname>Khaemba</senderfamilyname> <senderstreetaddress>P.O. Box:27663-00506</senderstreetaddress> <sendercity>Nairobi</sendercity> <senderstate/> <senderpostcode>00506</senderpostcode> <sendercountrycode>KE</sendercountrycode> <sendertel>720608811</sendertel> <sendertelextension/> <sendertelcountrycode>254</sendertelcountrycode> <senderfax>2713409</senderfax> <senderfaxextension>20</senderfaxextension> <senderfaxcountrycode>254</senderfaxcountrycode> <senderemailaddress>pv@pharmacyboardkenya.org</senderemailaddress> </sender> <receiver> <receivertype/> <receiverorganization/> <receiverdepartment/> <receivertitle/> <receivergivename/> <receivermiddlename/> <receiverfamilyname/> <receiverstreetaddress/> <receivercity/> <receiverstate/> <receiverpostcode/> <receivercountrycode/> <receivertel/> <receivertelextension/> <receivertelcountrycode/> <receiverfax/> <receiverfaxextension/> <receiverfaxcountrycode/> <receiveremailaddress/> </receiver> <patient> <patientinitial>Mr. Ibo</patientinitial> <patientgpmedicalrecordnumb></patientgpmedicalrecordnumb> <patientspecialistrecordnumb></patientspecialistrecordnumb> <patienthospitalrecordnumb></patienthospitalrecordnumb> <patientinvestigationnumb/> <patientbirthdateformat/> <patientbirthdate/> <patientonsetage/> <patientonsetageunit/> <gestationperiod/> <gestationperiodunit/> <patientagegroup>5</patientagegroup> <patientweight></patientweight> <patientheight>0</patientheight> <patientsex>1</patientsex> <lastmenstrualdateformat/> <patientlastmenstrualdate/> <patientmedicalhistorytext></patientmedicalhistorytext> <resultstestsprocedures></resultstestsprocedures> <patientdeath> <patientdeathdateformat/> <patientdeathdate/> <patientautopsyyesno/> </patientdeath> <reaction> <primarysourcereaction>(Intense) Dizziness, headache and Nausea</primarysourcereaction> <reactionmeddraversionllt>23.0</reactionmeddraversionllt> <reactionmeddrallt>Diethylcarbamazine and Albendazole related intense Dizziness, Headache and Nausea </reactionmeddrallt> <reactionmeddraversionpt></reactionmeddraversionpt> <reactionmeddrapt></reactionmeddrapt> <termhighlighted/> <reactionstartdateformat> 102</reactionstartdateformat> <reactionstartdate>20241114</reactionstartdate> <reactionenddateformat/> <reactionenddate/> <reactionduration/> <reactiondurationunit/> <reactionfirsttime/> <reactionfirsttimeunit/> <reactionlasttime/> <reactionlasttimeunit/> <reactionoutcome>6</reactionoutcome> </reaction> <drug> <drugcharacterization>1</drugcharacterization> <medicinalproduct>DEC</medicinalproduct> <obtaindrugcountry/> <drugbatchnumb/> <drugauthorizationnumb/> <drugauthorizationcountry/> <drugauthorizationholder/> <drugstructuredosagenumb>400</drugstructuredosagenumb> <drugstructuredosageunit>003</drugstructuredosageunit> <drugseparatedosagenumb/> <drugintervaldosageunitnumb/> <drugintervaldosagedefinition/> <drugcumulativedosagenumb/> <drugcumulativedosageunit/> <drugdosagetext/> <drugdosageform/> <drugadministrationroute>048</drugadministrationroute> <drugparadministration/> <reactiongestationperiod/> <reactiongestationperiodunit/> <drugindicationmeddraversion/> <drugindication>MDA</drugindication> <drugstartdateformat>102</drugstartdateformat> <drugstartdate>20241114</drugstartdate> <drugstartperiod/> <drugstartperiodunit/> <druglastperiod/> <druglastperiodunit/> <drugenddateformat>102</drugenddateformat> <drugenddate>20241114</drugenddate> <drugtreatmentduration/> <drugtreatmentdurationunit/> <actiondrug>4</actiondrug> <drugrecurreadministration/> <drugadditional/> <activesubstance> <activesubstancename>Diethylcarbamazine </activesubstancename> </activesubstance> <drugreactionrelatedness> <drugreactionassesmeddraversion /> <drugreactionasses /> <drugassessmentsource/> <drugassessmentmethod /> <drugresult /> </drugreactionrelatedness> </drug> <summary> <narrativeincludeclinical>The patient started complaining of intense dizziness, headache and nausea eight hours after taking the aforementioned drugs. </narrativeincludeclinical> <reportercomment></reportercomment> <senderdiagnosismeddraversion /> <senderdiagnosis /> <sendercomment/> </summary> </patient> </safetyreport> </ichicsr>
      • e2b_file(null)
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      • dirnamegen
      • basenamesadr_761.xml
      • checksum3d5f30069cc95a14f61278b8091c89e8
      • alternative(null)
      • group(null)
      • descriptionSample Comment
      • created2024-11-29 12:27:14
      • modified2024-11-29 12:27:14
  • StudyRoute(array)
    • 0(array)
      • id509
      • application_id121
      • study_routeophthalmic
      • created2024-11-20 09:47:01
      • modified2024-11-20 10:15:06
    • 1(array)
      • id510
      • application_id121
      • study_routeintra-amniotic
      • created2024-11-20 09:47:01
      • modified2024-11-20 10:15:06
    • 2(array)
      • id511
      • application_id121
      • study_routeintradiscal (intraspinal)
      • created2024-11-20 09:47:01
      • modified2024-11-20 10:15:06
  • Manufacturer(array)
    • 0(array)
      • id32
      • application_id121
      • manufacturer_nameMaisie Mccullough
      • addressLorem porro aspernatur deleniti veniam officiis est cupiditate rem libero occaecat
      • manufacturer_countryBrazil
      • manufacturer_phone+1 (525) 411-3839
      • manufacturer_emailpaseqid@mailinator.com
      • manufacturing_activitiesComplete manufacturing activities
      • other_specifyNobis deserunt ut non odio sunt laborum eos eum
      • created2024-11-20 09:47:01
      • modified2024-11-20 10:15:06
  • Reassignment(empty)
  • Attachment(empty)
  • AnnualApproval(array)
    • 0(array)
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      • foreign_key121
      • dirnameimg
      • basenamescreenshot_from_2024_11_28_11_17_15_2.png
      • checksum0dc2ff8fde7772c650757335f1f26ca4
      • alternative(null)
      • groupCover Letter
      • descriptionCover Letter (Should list all the submitted documents, their version numbers and dates)
      • year2024
      • file_date29-11-2024
      • pocket_nameCover Letter
      • version_no6
      • created2024-11-29 09:42:55
      • modified2024-11-29 09:42:55
      • pathimg/screenshot_from_2024_11_28_11_17_15_2.png
    • 1(array)
      • id1100
      • modelAnnualApproval
      • file/var/www/ctr/app/webroot/media/transfer/img/logo_28.png
      • foreign_key121
      • dirnameimg
      • basenamelogo_28.png
      • checksumc0a119cbad26d41a09d41f4c87635f4e
      • alternative(null)
      • groupprogress_report
      • descriptionAnnual progress report
      • year2024
      • file_date02-12-2024
      • pocket_nameprogress_report
      • version_no1
      • created2024-12-17 07:09:08
      • modified2024-12-17 07:09:08
      • pathimg/logo_28.png
    • 2(array)
      • id1101
      • modelAnnualApproval
      • file/var/www/ctr/app/webroot/media/transfer/img/logo_29.png
      • foreign_key121
      • dirnameimg
      • basenamelogo_29.png
      • checksumc0a119cbad26d41a09d41f4c87635f4e
      • alternative(null)
      • groupsae_susar_log
      • descriptionSAE and SUSAR cumulative logs
      • year2024
      • file_date25-11-2024
      • pocket_namesae_susar_log
      • version_no2
      • created2024-12-17 07:09:20
      • modified2024-12-17 07:09:20
      • pathimg/logo_29.png
    • 3(array)
      • id1102
      • modelAnnualApproval
      • file/var/www/ctr/app/webroot/media/transfer/img/logo_30.png
      • foreign_key121
      • dirnameimg
      • basenamelogo_30.png
      • checksumc0a119cbad26d41a09d41f4c87635f4e
      • alternative(null)
      • groupsigned_checklist
      • descriptionA signed checklist confirming the submission of the document
      • year2024
      • file_date19-12-2024
      • pocket_namesigned_checklist
      • version_no4
      • created2024-12-17 07:13:11
      • modified2024-12-17 07:13:11
      • pathimg/logo_30.png
    • 4(array)
      • id1103
      • modelAnnualApproval
      • file/var/www/ctr/app/webroot/media/transfer/img/logo_31.png
      • foreign_key121
      • dirnameimg
      • basenamelogo_31.png
      • checksumc0a119cbad26d41a09d41f4c87635f4e
      • alternative(null)
      • grouppan_african
      • descriptionEvidence of registration of the study at Pan African Clinical Trials Registry https://pactr.samrc.ac.za
      • year2024
      • file_date02-12-2024
      • pocket_namepan_african
      • version_no3
      • created2024-12-17 07:13:15
      • modified2024-12-17 07:13:15
      • pathimg/logo_31.png
    • 5(array)
      • id1104
      • modelAnnualApproval
      • file/var/www/ctr/app/webroot/media/transfer/img/logo_32.png
      • foreign_key121
      • dirnameimg
      • basenamelogo_32.png
      • checksumc0a119cbad26d41a09d41f4c87635f4e
      • alternative(null)
      • groupinsurance_cover
      • descriptionCopy of valid participants’ clinical trials insurance cover
      • year2024
      • file_date03-12-2024
      • pocket_nameinsurance_cover
      • version_no2
      • created2024-12-17 07:13:18
      • modified2024-12-17 07:13:18
      • pathimg/logo_32.png
    • 6(array)
      • id1105
      • modelAnnualApproval
      • file/var/www/ctr/app/webroot/media/transfer/img/logo_33.png
      • foreign_key121
      • dirnameimg
      • basenamelogo_33.png
      • checksumc0a119cbad26d41a09d41f4c87635f4e
      • alternative(null)
      • groupindemnity_cover_pharmacist
      • descriptionCopy of the valid professional indemnity insurance cover for the study pharmacist
      • year2024
      • file_date02-12-2024
      • pocket_nameindemnity_cover_pharmacist
      • version_no4
      • created2024-12-17 07:13:20
      • modified2024-12-17 07:13:20
      • pathimg/logo_33.png
    • 7(array)
      • id1106
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      • file/var/www/ctr/app/webroot/media/transfer/img/logo_34.png
      • foreign_key121
      • dirnameimg
      • basenamelogo_34.png
      • checksumc0a119cbad26d41a09d41f4c87635f4e
      • alternative(null)
      • groupindemnity_cover_investigator
      • descriptionCopy of the valid professional indemnity insurance cover for the investigators
      • year2024
      • file_date02-12-2024
      • pocket_nameindemnity_cover_investigator
      • version_no3
      • created2024-12-17 07:13:23
      • modified2024-12-17 07:13:23
      • pathimg/logo_34.png
    • 8(array)
      • id1107
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      • file/var/www/ctr/app/webroot/media/transfer/img/logo_35.png
      • foreign_key121
      • dirnameimg
      • basenamelogo_35.png
      • checksumc0a119cbad26d41a09d41f4c87635f4e
      • alternative(null)
      • groupannual_practice_pharmacist
      • descriptionCopy of the Annual Practice License for the Pharmacist
      • year2024
      • file_date02-12-2024
      • pocket_nameannual_practice_pharmacist
      • version_no2
      • created2024-12-17 07:13:26
      • modified2024-12-17 07:13:26
      • pathimg/logo_35.png
    • 9(array)
      • id1108
      • modelAnnualApproval
      • file/var/www/ctr/app/webroot/media/transfer/img/logo_36.png
      • foreign_key121
      • dirnameimg
      • basenamelogo_36.png
      • checksumc0a119cbad26d41a09d41f4c87635f4e
      • alternative(null)
      • groupannual_practice_investigator
      • descriptionCopy of the Annual Practice License of the Investigators
      • year2024
      • file_date02-12-2024
      • pocket_nameannual_practice_investigator
      • version_no2
      • created2024-12-17 07:13:31
      • modified2024-12-17 07:13:31
      • pathimg/logo_36.png
    • 10(array)
      • id1109
      • modelAnnualApproval
      • file/var/www/ctr/app/webroot/media/transfer/img/logo_37.png
      • foreign_key121
      • dirnameimg
      • basenamelogo_37.png
      • checksumc0a119cbad26d41a09d41f4c87635f4e
      • alternative(null)
      • grouperc
      • descriptionCopy of current favourable opinion letter from the local Ethics Review Committee (ERC).
      • year2024
      • file_date02-12-2024
      • pocket_nameerc
      • version_no1
      • created2024-12-17 07:13:34
      • modified2024-12-17 07:13:34
      • pathimg/logo_37.png
    • 11(array)
      • id1110
      • modelAnnualApproval
      • file/var/www/ctr/app/webroot/media/transfer/img/logo_38.png
      • foreign_key121
      • dirnameimg
      • basenamelogo_38.png
      • checksumc0a119cbad26d41a09d41f4c87635f4e
      • alternative(null)
      • groupdsur
      • descriptionThe Development Safety Update Report (DSUR)
      • year2024
      • file_date09-12-2024
      • pocket_namedsur
      • version_no1
      • created2024-12-17 07:13:36
      • modified2024-12-17 07:13:36
      • pathimg/logo_38.png
    • 12(array)
      • id1111
      • modelAnnualApproval
      • file/var/www/ctr/app/webroot/media/transfer/img/logo_39.png
      • foreign_key121
      • dirnameimg
      • basenamelogo_39.png
      • checksumc0a119cbad26d41a09d41f4c87635f4e
      • alternative(null)
      • groupimpd
      • descriptionUpdated Investigators Brochure/Package inserts or Investigational Medicinal Product Dossier (IMPD)
      • year2024
      • file_date25-11-2024
      • pocket_nameimpd
      • version_no1
      • created2024-12-17 07:13:38
      • modified2024-12-17 07:13:38
      • pathimg/logo_39.png
    • 13(array)
      • id1112
      • modelAnnualApproval
      • file/var/www/ctr/app/webroot/media/transfer/img/logo_40.png
      • foreign_key121
      • dirnameimg
      • basenamelogo_40.png
      • checksumc0a119cbad26d41a09d41f4c87635f4e
      • alternative(null)
      • groupprotocol_violations
      • descriptionProtocol Violations and Protocol Deviations logs
      • year2024
      • file_date02-12-2024
      • pocket_nameprotocol_violations
      • version_no1
      • created2024-12-17 07:13:40
      • modified2024-12-17 07:13:40
      • pathimg/logo_40.png
    • 14(array)
      • id1113
      • modelAnnualApproval
      • file/var/www/ctr/app/webroot/media/transfer/img/logo_41.png
      • foreign_key121
      • dirnameimg
      • basenamelogo_41.png
      • checksumc0a119cbad26d41a09d41f4c87635f4e
      • alternative(null)
      • groupdsmb
      • descriptionLatest Data Safety Monitoring Board (DSMB) report
      • year2024
      • file_date02-12-2024
      • pocket_namedsmb
      • version_no1
      • created2024-12-17 07:13:44
      • modified2024-12-17 07:13:44
      • pathimg/logo_41.png
  • AmendmentChecklist(empty)
  • Reminder(empty)
  • ParticipantFlow(empty)
  • Budget(array)
    • 0(array)
      • id32
      • application_id121
      • year(null)
      • budget_period(null)
      • personnel_currencyEUR
      • personnelIpsam fugia
      • transport_currencyEUR
      • transportPossimus p
      • field_currencyKES
      • fieldEsse qui se
      • supplies_currencyKES
      • suppliesMinima quia
      • pharmacy_currencyUSD
      • pharmacyAccusamus n
      • travel_currencyUSD
      • travelObcaecati s
      • regulatory_currencyKES
      • regulatoryEa dolores
      • it_currencyEUR
      • itError sint
      • lab_currency(null)
      • lab(null)
      • others_currencyEUR
      • othersNon perfere
      • kemri_currency(null)
      • kemri(null)
      • wrair_currency(null)
      • wrair(null)
      • subject_currencyKES
      • subjectOfficia rep
      • grand_currencyKES
      • grand_totalOfficia ame
      • study_informationTempor rerum dolorem
      • personnel_kshsEst repudi
      • transport_kshsIncidunt a
      • field_kshsRatione par
      • supplies_kshsEsse esse
      • pharmacy_kshsEst sint f
      • travel_kshsEt culpa qu
      • regulatory_kshsLaboris rep
      • it_kshsNisi est v
      • lab_kshs(null)
      • others_kshsVoluptatem
      • grand_total_kshsRem quam ve
      • subject_kshsFugiat at
      • created2024-11-20 09:47:01
      • modified2024-11-20 10:15:06
  • Deviation(empty)
  • Document(empty)
  • CoverLetter(empty)
  • Protocol(empty)
  • PatientLeaflet(empty)
  • Brochure(empty)
  • GmpCertificate(empty)
  • Cv(empty)
  • Finance(empty)
  • Declaration(empty)
  • IndemnityCover(empty)
  • OpinionLetter(empty)
  • ApprovalLetter(empty)
  • Statement(empty)
  • ParticipatingStudy(empty)
  • Addendum(empty)
  • Registration(empty)
  • Fee(empty)
  • Checklist(array)
    • 0(array)
      • id1042
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2024_11_20_08_51_47.png
      • foreign_key121
      • dirnameimg
      • basenamescreenshot_from_2024_11_20_08_51_47.png
      • checksum9e503ade36341f566429e27192cb5b34
      • alternative(null)
      • groupapplicant_covering_letter
      • descriptionCover Letter (Should list all the submitted documents, their version numbers and dates) *
      • year(null)
      • file_date01-11-2024
      • pocket_nameapplicant_covering_letter
      • version_no3
      • created2024-11-20 10:08:40
      • modified2024-11-20 10:15:06
      • pathimg/screenshot_from_2024_11_20_08_51_47.png
    • 1(array)
      • id1043
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2024_11_20_08_51_47_2.png
      • foreign_key121
      • dirnameimg
      • basenamescreenshot_from_2024_11_20_08_51_47_2.png
      • checksum9e503ade36341f566429e27192cb5b34
      • alternative(null)
      • groupapplicant_protocol
      • descriptionThe Study Protocol *
      • year(null)
      • file_date02-11-2024
      • pocket_nameapplicant_protocol
      • version_no3
      • created2024-11-20 10:08:51
      • modified2024-11-20 10:15:06
      • pathimg/screenshot_from_2024_11_20_08_51_47_2.png
    • 2(array)
      • id1044
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2024_11_20_08_51_47_3.png
      • foreign_key121
      • dirnameimg
      • basenamescreenshot_from_2024_11_20_08_51_47_3.png
      • checksum9e503ade36341f566429e27192cb5b34
      • alternative(null)
      • groupapplicant_protocol
      • descriptionThe Study Protocol *
      • year(null)
      • file_date07-11-2024
      • pocket_nameapplicant_protocol
      • version_no3
      • created2024-11-20 10:09:07
      • modified2024-11-20 10:09:07
      • pathimg/screenshot_from_2024_11_20_08_51_47_3.png
    • 3(array)
      • id1045
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2024_11_20_08_51_47_4.png
      • foreign_key121
      • dirnameimg
      • basenamescreenshot_from_2024_11_20_08_51_47_4.png
      • checksum9e503ade36341f566429e27192cb5b34
      • alternative(null)
      • groupapplicant_pan_african
      • descriptionRegistration of the study at Pan African Clinical Trials Registry https://pactr.samrc.ac.za *
      • year(null)
      • file_date03-11-2024
      • pocket_nameapplicant_pan_african
      • version_no3
      • created2024-11-20 10:09:20
      • modified2024-11-20 10:09:20
      • pathimg/screenshot_from_2024_11_20_08_51_47_4.png
    • 4(array)
      • id1046
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2024_11_20_08_51_47_5.png
      • foreign_key121
      • dirnameimg
      • basenamescreenshot_from_2024_11_20_08_51_47_5.png
      • checksum9e503ade36341f566429e27192cb5b34
      • alternative(null)
      • groupapplicant_patient_information
      • descriptionPatient Information leaflet and Informed consent form *
      • year(null)
      • file_date04-11-2024
      • pocket_nameapplicant_patient_information
      • version_no3
      • created2024-11-20 10:09:40
      • modified2024-11-20 10:09:40
      • pathimg/screenshot_from_2024_11_20_08_51_47_5.png
    • 5(array)
      • id1047
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2024_11_20_08_51_47_6.png
      • foreign_key121
      • dirnameimg
      • basenamescreenshot_from_2024_11_20_08_51_47_6.png
      • checksum9e503ade36341f566429e27192cb5b34
      • alternative(null)
      • groupapplicant_investigators_brochure
      • descriptionInvestigators Brochure/Package inserts *
      • year(null)
      • file_date05-11-2024
      • pocket_nameapplicant_investigators_brochure
      • version_no3
      • created2024-11-20 10:09:49
      • modified2024-11-20 10:09:49
      • pathimg/screenshot_from_2024_11_20_08_51_47_6.png
    • 6(array)
      • id1048
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2024_11_20_08_51_47_7.png
      • foreign_key121
      • dirnameimg
      • basenamescreenshot_from_2024_11_20_08_51_47_7.png
      • checksum9e503ade36341f566429e27192cb5b34
      • alternative(null)
      • groupapplicant_impd
      • descriptionInvestigational Medicinal Product Dossier (IMPD) *
      • year(null)
      • file_date07-11-2024
      • pocket_nameapplicant_impd
      • version_no3
      • created2024-11-20 10:10:01
      • modified2024-11-20 10:10:01
      • pathimg/screenshot_from_2024_11_20_08_51_47_7.png
    • 7(array)
      • id1049
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2024_11_20_08_51_47_8.png
      • foreign_key121
      • dirnameimg
      • basenamescreenshot_from_2024_11_20_08_51_47_8.png
      • checksum9e503ade36341f566429e27192cb5b34
      • alternative(null)
      • groupapplicant_prev_data
      • descriptionAdequate data and information from previous studies and Phases to support carrying out of the current study *
      • year(null)
      • file_date07-11-2024
      • pocket_nameapplicant_prev_data
      • version_no3
      • created2024-11-20 10:10:15
      • modified2024-11-20 10:10:15
      • pathimg/screenshot_from_2024_11_20_08_51_47_8.png
    • 8(array)
      • id1050
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2024_11_20_08_51_47_9.png
      • foreign_key121
      • dirnameimg
      • basenamescreenshot_from_2024_11_20_08_51_47_9.png
      • checksum9e503ade36341f566429e27192cb5b34
      • alternative(null)
      • groupapplicant_stability_data
      • descriptionStability data of the investigational product *
      • year(null)
      • file_date09-11-2024
      • pocket_nameapplicant_stability_data
      • version_no3
      • created2024-11-20 10:10:25
      • modified2024-11-20 10:10:25
      • pathimg/screenshot_from_2024_11_20_08_51_47_9.png
    • 9(array)
      • id1051
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2024_11_20_08_51_47_10.png
      • foreign_key121
      • dirnameimg
      • basenamescreenshot_from_2024_11_20_08_51_47_10.png
      • checksum9e503ade36341f566429e27192cb5b34
      • alternative(null)
      • groupapplicant_gmp_certificate
      • descriptionGMP certificate of the investigational product from the site of manufacture *
      • year(null)
      • file_date07-11-2024
      • pocket_nameapplicant_gmp_certificate
      • version_no3
      • created2024-11-20 10:10:35
      • modified2024-11-20 10:10:35
      • pathimg/screenshot_from_2024_11_20_08_51_47_10.png
    • 10(array)
      • id1052
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2024_11_20_08_51_47_11.png
      • foreign_key121
      • dirnameimg
      • basenamescreenshot_from_2024_11_20_08_51_47_11.png
      • checksum9e503ade36341f566429e27192cb5b34
      • alternative(null)
      • groupapplicant_analysis_cert
      • descriptionCertificate of Analysis of the investigational product *
      • year(null)
      • file_date09-11-2024
      • pocket_nameapplicant_analysis_cert
      • version_no3
      • created2024-11-20 10:10:46
      • modified2024-11-20 10:10:46
      • pathimg/screenshot_from_2024_11_20_08_51_47_11.png
    • 11(array)
      • id1053
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2024_11_20_08_51_47_12.png
      • foreign_key121
      • dirnameimg
      • basenamescreenshot_from_2024_11_20_08_51_47_12.png
      • checksum9e503ade36341f566429e27192cb5b34
      • alternative(null)
      • groupapplicant_pictorial_sample
      • descriptionPictorial Sample of the investigational products. This sample should include the text of the labeling to be used *
      • year(null)
      • file_date20-11-2024
      • pocket_nameapplicant_pictorial_sample
      • version_no3
      • created2024-11-20 10:10:56
      • modified2024-11-20 10:10:56
      • pathimg/screenshot_from_2024_11_20_08_51_47_12.png
    • 12(array)
      • id1054
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2024_11_20_08_51_47_13.png
      • foreign_key121
      • dirnameimg
      • basenamescreenshot_from_2024_11_20_08_51_47_13.png
      • checksum9e503ade36341f566429e27192cb5b34
      • alternative(null)
      • groupapplicant_investigators_cv
      • descriptionSigned investigator(s) CV(s) including that of study Pharmacist (NB: The CV should include the current workload of the Principal Investigator ) *
      • year(null)
      • file_date14-11-2024
      • pocket_nameapplicant_investigators_cv
      • version_no3
      • created2024-11-20 10:11:08
      • modified2024-11-20 10:11:08
      • pathimg/screenshot_from_2024_11_20_08_51_47_13.png
    • 13(array)
      • id1055
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2024_11_20_08_51_47_14.png
      • foreign_key121
      • dirnameimg
      • basenamescreenshot_from_2024_11_20_08_51_47_14.png
      • checksum9e503ade36341f566429e27192cb5b34
      • alternative(null)
      • groupapplicant_contractual_agreement
      • descriptionEvidence of contractual agreement between sponsor and Principal Investigator. *
      • year(null)
      • file_date07-11-2024
      • pocket_nameapplicant_contractual_agreement
      • version_no3
      • created2024-11-20 10:11:59
      • modified2024-11-20 10:11:59
      • pathimg/screenshot_from_2024_11_20_08_51_47_14.png
    • 14(array)
      • id1056
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2024_11_20_08_51_47_15.png
      • foreign_key121
      • dirnameimg
      • basenamescreenshot_from_2024_11_20_08_51_47_15.png
      • checksum9e503ade36341f566429e27192cb5b34
      • alternative(null)
      • groupapplicant_gcp_training
      • descriptionEvidence of recent GCP training of the core study staff *
      • year(null)
      • file_date07-11-2024
      • pocket_nameapplicant_gcp_training
      • version_no4
      • created2024-11-20 10:12:10
      • modified2024-11-20 10:12:10
      • pathimg/screenshot_from_2024_11_20_08_51_47_15.png
    • 15(array)
      • id1057
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2024_11_20_08_51_47_16.png
      • foreign_key121
      • dirnameimg
      • basenamescreenshot_from_2024_11_20_08_51_47_16.png
      • checksum9e503ade36341f566429e27192cb5b34
      • alternative(null)
      • groupapplicant_dsmb_charter
      • descriptionDSMB Charter including the composition and meeting schedule *
      • year(null)
      • file_date07-11-2024
      • pocket_nameapplicant_dsmb_charter
      • version_no4
      • created2024-11-20 10:12:19
      • modified2024-11-20 10:12:19
      • pathimg/screenshot_from_2024_11_20_08_51_47_16.png
    • 16(array)
      • id1058
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2024_11_20_08_51_47_17.png
      • foreign_key121
      • dirnameimg
      • basenamescreenshot_from_2024_11_20_08_51_47_17.png
      • checksum9e503ade36341f566429e27192cb5b34
      • alternative(null)
      • groupapplicant_detailed_budget
      • descriptionDetailed budget of the study *
      • year(null)
      • file_date13-11-2024
      • pocket_nameapplicant_detailed_budget
      • version_no4
      • created2024-11-20 10:12:29
      • modified2024-11-20 10:12:29
      • pathimg/screenshot_from_2024_11_20_08_51_47_17.png
    • 17(array)
      • id1059
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2024_11_20_08_51_47_18.png
      • foreign_key121
      • dirnameimg
      • basenamescreenshot_from_2024_11_20_08_51_47_18.png
      • checksum9e503ade36341f566429e27192cb5b34
      • alternative(null)
      • groupapplicant_financial_declaration
      • descriptionFinancial declaration by Sponsor and/or PI *
      • year(null)
      • file_date06-11-2024
      • pocket_nameapplicant_financial_declaration
      • version_no4
      • created2024-11-20 10:12:37
      • modified2024-11-20 10:12:37
      • pathimg/screenshot_from_2024_11_20_08_51_47_18.png
    • 18(array)
      • id1060
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2024_11_20_08_51_47_19.png
      • foreign_key121
      • dirnameimg
      • basenamescreenshot_from_2024_11_20_08_51_47_19.png
      • checksum9e503ade36341f566429e27192cb5b34
      • alternative(null)
      • groupapplicant_signed_declaration
      • descriptionSigned Declaration by Sponsor or Principal investigator that the study will be carried out according to the protocol and applicable laws, regulations and GCP requirements. *
      • year(null)
      • file_date14-11-2024
      • pocket_nameapplicant_signed_declaration
      • version_no4
      • created2024-11-20 10:12:47
      • modified2024-11-20 10:12:47
      • pathimg/screenshot_from_2024_11_20_08_51_47_19.png
    • 19(array)
      • id1061
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2024_11_20_08_51_47_20.png
      • foreign_key121
      • dirnameimg
      • basenamescreenshot_from_2024_11_20_08_51_47_20.png
      • checksum9e503ade36341f566429e27192cb5b34
      • alternative(null)
      • groupapplicant_indemnity_pi
      • descriptionIndemnity cover for PI, investigators and study Pharmacist. *
      • year(null)
      • file_date11-11-2024
      • pocket_nameapplicant_indemnity_pi
      • version_no4
      • created2024-11-20 10:12:56
      • modified2024-11-20 10:12:56
      • pathimg/screenshot_from_2024_11_20_08_51_47_20.png
    • 20(array)
      • id1062
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2024_11_20_08_51_47_21.png
      • foreign_key121
      • dirnameimg
      • basenamescreenshot_from_2024_11_20_08_51_47_21.png
      • checksum9e503ade36341f566429e27192cb5b34
      • alternative(null)
      • groupapplicant_indemnity_cover
      • descriptionClinical Trials Insurance cover for study participants *
      • year(null)
      • file_date05-11-2024
      • pocket_nameapplicant_indemnity_cover
      • version_no4
      • created2024-11-20 10:13:04
      • modified2024-11-20 10:13:04
      • pathimg/screenshot_from_2024_11_20_08_51_47_21.png
    • 21(array)
      • id1063
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2024_11_20_08_51_47_22.png
      • foreign_key121
      • dirnameimg
      • basenamescreenshot_from_2024_11_20_08_51_47_22.png
      • checksum9e503ade36341f566429e27192cb5b34
      • alternative(null)
      • groupapplicant_opinion_letter
      • descriptionCopy of favorable opinion letter from the local Ethics Review Committee (ERC). *
      • year(null)
      • file_date05-11-2024
      • pocket_nameapplicant_opinion_letter
      • version_no4
      • created2024-11-20 10:13:14
      • modified2024-11-20 10:13:14
      • pathimg/screenshot_from_2024_11_20_08_51_47_22.png
    • 22(array)
      • id1064
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2024_11_20_08_51_47_23.png
      • foreign_key121
      • dirnameimg
      • basenamescreenshot_from_2024_11_20_08_51_47_23.png
      • checksum9e503ade36341f566429e27192cb5b34
      • alternative(null)
      • groupapplicant_practice_license
      • descriptionCopy of current Practice Licenses for the Investigators and study Pharmacist *
      • year(null)
      • file_date12-11-2024
      • pocket_nameapplicant_practice_license
      • version_no4
      • created2024-11-20 10:13:24
      • modified2024-11-20 10:13:24
      • pathimg/screenshot_from_2024_11_20_08_51_47_23.png
    • 23(array)
      • id1065
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2024_11_20_08_51_47_24.png
      • foreign_key121
      • dirnameimg
      • basenamescreenshot_from_2024_11_20_08_51_47_24.png
      • checksum9e503ade36341f566429e27192cb5b34
      • alternative(null)
      • groupapplicant_approval_letter
      • descriptionCopy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable
      • year(null)
      • file_date06-11-2024
      • pocket_nameapplicant_approval_letter
      • version_no4
      • created2024-11-20 10:13:32
      • modified2024-11-20 10:13:32
      • pathimg/screenshot_from_2024_11_20_08_51_47_24.png
    • 24(array)
      • id1066
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2024_11_20_08_51_47_25.png
      • foreign_key121
      • dirnameimg
      • basenamescreenshot_from_2024_11_20_08_51_47_25.png
      • checksum9e503ade36341f566429e27192cb5b34
      • alternative(null)
      • groupapplicant_addendum
      • descriptionFor multicentre/multi-site studies, a site specific addendum for each of the proposed sites including among other things the sites’ capacity to carry out the study i.e personnel, equipment, laboratory etc
      • year(null)
      • file_date04-11-2024
      • pocket_nameapplicant_addendum
      • version_no4
      • created2024-11-20 10:13:42
      • modified2024-11-20 10:13:42
      • pathimg/screenshot_from_2024_11_20_08_51_47_25.png
    • 25(array)
      • id1067
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2024_11_20_08_51_47_26.png
      • foreign_key121
      • dirnameimg
      • basenamescreenshot_from_2024_11_20_08_51_47_26.png
      • checksum9e503ade36341f566429e27192cb5b34
      • alternative(null)
      • groupapplicant_statement
      • descriptionA signed statement by the applicant indicating that all information contained in, or referenced by, the application is complete and accurate and is not false or misleading. *
      • year(null)
      • file_date12-11-2024
      • pocket_nameapplicant_statement
      • version_no4
      • created2024-11-20 10:13:52
      • modified2024-11-20 10:13:52
      • pathimg/screenshot_from_2024_11_20_08_51_47_26.png
    • 26(array)
      • id1068
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2024_11_20_08_51_47_27.png
      • foreign_key121
      • dirnameimg
      • basenamescreenshot_from_2024_11_20_08_51_47_27.png
      • checksum9e503ade36341f566429e27192cb5b34
      • alternative(null)
      • groupapplicant_fees
      • descriptionPayment of fees *
      • year(null)
      • file_date11-11-2024
      • pocket_nameapplicant_fees
      • version_no4
      • created2024-11-20 10:14:07
      • modified2024-11-20 10:14:07
      • pathimg/screenshot_from_2024_11_20_08_51_47_27.png
    • 27(array)
      • id1069
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2024_11_20_08_51_47_28.png
      • foreign_key121
      • dirnameimg
      • basenamescreenshot_from_2024_11_20_08_51_47_28.png
      • checksum9e503ade36341f566429e27192cb5b34
      • alternative(null)
      • groupstatistical_analysis_plan
      • descriptionStatistical Analysis Plan *
      • year(null)
      • file_date11-11-2024
      • pocket_namestatistical_analysis_plan
      • version_no4
      • created2024-11-20 10:14:15
      • modified2024-11-20 10:14:15
      • pathimg/screenshot_from_2024_11_20_08_51_47_28.png
    • 28(array)
      • id1070
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2024_11_20_08_51_47_29.png
      • foreign_key121
      • dirnameimg
      • basenamescreenshot_from_2024_11_20_08_51_47_29.png
      • checksum9e503ade36341f566429e27192cb5b34
      • alternative(null)
      • groupapplicant_signed_checklist
      • descriptionSigned Checklist *
      • year(null)
      • file_date11-11-2024
      • pocket_nameapplicant_signed_checklist
      • version_no4
      • created2024-11-20 10:14:26
      • modified2024-11-20 10:14:26
      • pathimg/screenshot_from_2024_11_20_08_51_47_29.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

App Constants

CakePHP Constants

PHP Environment

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