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• application(array)
  • Application(array)
    • id248
    • user_id29
    • application_id(null)
    • is_child0
    • trial_status_id(null)
    • total_sites3
    • abstract_of_study<p> Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>
    • study_title<p> Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>
    • laymans_summary<p> Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>
    • short_titleQui exercitation ut officia ob
    • protocol_noECCT/26/02/02
    • reference_no(null)
    • version_noMolestiae expedita dolores aliquam blanditiis excepteur
    • date_of_protocol23-02-2026
    • study_drugOfficia dolores suscipit dignissimos porro quos aut magna aut asperiores quis
    • disease_conditionQuis soluta consectetur aut ipsam aute commodi quia
    • product_type_biologicals0
    • product_type_proteins1
    • product_type_immunologicals1
    • product_type_vaccines0
    • product_type_hormones0
    • product_type_toxoid0
    • product_type_chemical0
    • product_type_medical_device1
    • product_type_chemical_nameMorgan Goff
    • product_type_medical_device_nameAlexis Workman
    • comparatorYes
    • comparator_nameMartina Glover
    • comparator_registeredCillum deserunt cumque tenetur
    • comparator_countriesDolor ipsam illum n
    • ecct_not_applicable0
    • ecct_ref_number
    • email_addressjkiprotich@intellisoftkenya.com
    • applicant_covering_letter1
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    • applicant_approval_letter0
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    • applicant_participating_countries(null)
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    • applicant_analysis_cert0
    • applicant_pictorial_sample0
    • applicant_gcp_training0
    • applicant_dsmb_charter0
    • applicant_detailed_budget0
    • applicant_indemnity_pi0
    • applicant_practice_license0
    • applicant_registration_ctr(null)
    • applicant_pan_african0
    • applicant_hard_copies(null)
    • applicant_signed_checklist0
    • statistical_analysis_plan0
    • applicant_contractual_agreement0
    • declaration_applicantCommodi quisquam proident excepturi cum et atque qui voluptas sed commodi ad
    • declaration_date123-02-2026
    • declaration_principal_investigatorEaque ex aut omnis velit enim odit ut aut aut quis totam fugit nisi est enim maiores molestiae
    • declaration_date223-02-2026
    • placebo_presentYes
    • study_objectives<p> Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>
    • principal_inclusion_criteria<p> Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>
    • principal_exclusion_criteria<p> Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>
    • primary_end_points<p> Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>
    • scope_diagnosis1
    • scope_prophylaxis0
    • scope_therapy0
    • scope_safety1
    • scope_efficacy0
    • scope_pharmacokinetic1
    • scope_pharmacodynamic0
    • scope_bioequivalence1
    • scope_dose_response1
    • scope_pharmacogenetic1
    • scope_pharmacogenomic1
    • scope_pharmacoecomomic0
    • scope_others0
    • scope_others_specify
    • trial_human_pharmacology0
    • trial_administration_humans0
    • trial_bioequivalence_study1
    • trial_other1
    • trial_other_specifyRerum itaque eu illo
    • trial_therapeutic_exploratory1
    • trial_therapeutic_confirmatory1
    • trial_therapeutic_use1
    • design_controlledYes
    • site_capacity(null)
    • staff_numbers<p> Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>
    • other_details_explanation<p> Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>
    • other_details_regulatory_notapproved<p> Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>
    • other_details_regulatory_approved<p> Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>
    • other_details_regulatory_rejected<p> Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>
    • other_details_regulatory_halted<p> Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>
    • estimated_duration4
    • design_controlled_randomisedNo
    • design_controlled_openYes
    • design_controlled_single_blindNo
    • design_controlled_double_blindNo
    • design_controlled_parallel_groupNo
    • design_controlled_cross_overYes
    • design_controlled_otherYes
    • design_controlled_specifyQuasi sint deserunt totam libero voluptate tenetur voluptas ut dolor blanditiis sed sunt magni eu provident ut voluptate
    • design_controlled_comparatorExpedita anim aut deserun
    • design_controlled_other_medicinalYes
    • design_controlled_placeboYes
    • design_controlled_medicinal_otherNo
    • design_controlled_medicinal_specify
    • single_site_member_stateNo
    • location_of_area
    • single_site_physical_address
    • single_site_contact_person
    • single_site_telephone
    • multiple_sites_member_stateYes
    • multiple_countriesNo
    • multiple_member_states
    • number_of_sites4
    • multi_country_list
    • data_monitoring_committeeYes
    • total_enrolment_per_sitePorro non adipisicin
    • total_participants_worldwideVoluptatum alias rerum voluptatem laudantium labore proident consequatur mollitia
    • population_less_than_18_yearsYes
    • population_uteroYes
    • population_preterm_newbornNo
    • population_newbornYes
    • population_infant_and_toddlerYes
    • population_childrenYes
    • population_adolescentYes
    • population_above_18Yes
    • population_adultYes
    • population_elderlyYes
    • gender_female1
    • gender_male1
    • subjects_healthyNo
    • subjects_patientsNo
    • subjects_vulnerable_populationsYes
    • subjects_women_child_bearingNo
    • subjects_women_using_contraceptionYes
    • subjects_pregnant_womenNo
    • subjects_nursing_womenNo
    • subjects_emergency_situationNo
    • subjects_incapable_consentNo
    • subjects_specify
    • subjects_othersNo
    • subjects_others_specify
    • investigator1_given_nameDominic Douglas
    • investigator1_middle_nameRonan Jimenez
    • investigator1_family_nameAline Spears
    • investigator1_qualificationEos quasi esse amet ut corporis
    • investigator1_professional_addressMagni nihil et quas in similique magna velit ut et pariatur Eos sunt
    • investigator1_telephone+1 (392) 378-2765
    • investigator1_emailtofesegete@mailinator.com
    • organisations_transferred_Yes
    • number_participantsSunt quisquam quia i
    • notification<p> Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>
    • approval_date23-03-2026
    • submitted1
    • deleted0
    • deleted_date(null)
    • deactivated0
    • date_submitted25-02-2026
    • unsubmitted1
    • initial_date_submitted23-02-2026
    • admin_stopped0
    • admin_stopped_reason(null)
    • approved2
    • approved_reason
    • approved_date(null)
    • final_report(null)
    • implication_results(null)
    • quantity_imported(null)
    • quantity_dispensed(null)
    • quantity_destroyed(null)
    • quantity_exported(null)
    • balance_site(null)
    • final_date(null)
    • ecitizen_invoice436615
    • modified2026-03-23 12:03:26
    • created2026-02-23 06:56:12
    • ai_content1
  • User(array)
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    • usernamejkiprotich
    • password547f0111bc877d5579f28409dcb3dafc5439c785
    • confirm_password547f0111bc877d5579f28409dcb3dafc5439c785
    • nameJapheth Kiprotich
    • emailjkiprotich@intellisoftkenya.com
    • national_id_number32645167
    • sponsor(null)
    • sponsor_emailjkiprotich@intellisoftkenya.com
    • qualificationDentist
    • phone_no254724743788
    • name_of_institution
    • institution_physical
    • institution_address
    • institution_contact
    • county_id47
    • country_id115
    • group_id5
    • activation_key
    • forgot_password0
    • is_active1
    • deactivated0
    • created2024-01-19 06:00:03
    • modified2024-10-16 14:11:49
  • TrialStatus(array)
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    • created(null)
    • modified(null)
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      • created2026-02-23 08:02:46
      • modified2026-02-23 08:03:01
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      • created2026-02-23 08:03:06
      • modified2026-02-23 08:04:38
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      • user_id849
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      • title(null)
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      • summary<p> 1.1 Introduction</p> <p> Dolores et id vel v</p> <p>  </p> <p> The pharmacology studies provide the pharmacological basis for the proposed trial</p> <p> No</p> <p>  </p> <p> Were relevant in vitro and/or in vivo models studied?</p> <p> No</p> <p>  </p> <p> Is the intended pharmacological effect expected/ possible at clinical exposure?</p> <p> No</p> <p>  </p> <p> Were pharmacologically active major metabolites identified?</p> <p> N/A</p> <p>  </p> <p> Is the IMP a first-in-class compound?</p> <p> No</p> <p>  </p> <p> Primary pharmacodynamics workspace</p> <p> Obcaecati eum adipis</p> <p>  </p> <p> Primary pharmacodynamics comments</p> <p> Ut magni ad deleniti</p> <p>  </p> <p> The studies described in this section identified off-target effects</p> <p> N/A</p> <p>  </p> <p> Are off-target effects expected / possible at clinical exposure?</p> <p> No</p> <p>  </p> <p> Secondary pharmacodynamics workspace</p> <p> Quis amet sit ulla</p> <p>  </p> <p> Secondary pharmacodynamics comments</p> <p> Ea atque quod optio</p> <p>  </p> <p> Cardiovascular - Study type</p> <p> Tempore dolorem ita</p> <p>  </p> <p> Cardiovascular - Issues identified</p> <p> N/A</p> <p>  </p> <p> Cardiovascular - Major findings</p> <p> Nostrum non cupidita</p> <p>  </p> <p> Respiratory - Study type</p> <p> Laboriosam molestia</p> <p>  </p> <p> Respiratory - Issues identified</p> <p> No</p> <p>  </p> <p> Respiratory - Major findings</p> <p> Yes</p> <p>  </p> <p> CNS - Study type</p> <p> Aspernatur voluptatu</p> <p>  </p> <p> CNS - Issues identified</p> <p> N/A</p> <p>  </p> <p> CNS - Major findings</p> <p> Yes</p> <p>  </p> <p> Other - Study type</p> <p> Et laborum recusanda</p> <p>  </p> <p> Other - Issues identified</p> <p> No</p> <p>  </p> <p> Other - Major findings</p> <p> No</p> <p>  </p> <p> Did the safety pharmacology studies identify significant concerns?</p> <p> Yes</p> <p>  </p> <p> Do sufficient margins of exposure exist for planned clinical exposure?</p> <p> N/A</p> <p>  </p> <p> Safety pharmacology workspace</p> <p> Dolore impedit offi</p> <p>  </p> <p> Safety pharmacology comments</p> <p> Yes</p> <p>  </p> <p> Have potential pharmacodynamics drug interactions been identified?</p> <p> Yes</p> <p>  </p> <p> Pharmacodynamic drug interactions workspace</p> <p> Ea sint saepe recusa</p> <p>  </p> <p> Pharmacodynamic drug interactions comments</p> <p> Quia aute excepturi</p> <p>  </p> <p> Are the methods of analysis and their sensitivities adequate?</p> <p> Yes</p> <p>  </p> <p> Pharmacokinetics workspace</p> <p> Maxime rem quaerat e</p> <p>  </p> <p> Pharmacokinetics comments</p> <p> Enim illo ducimus v</p> <p>  </p> <p> Absorption - Issues identified</p> <p> N/A</p> <p>  </p> <p> Absorption - Findings</p> <p> Vitae dolor autem al</p> <p>  </p> <p> Distribution - Issues identified</p> <p> N/A</p> <p>  </p> <p> Distribution - Findings</p> <p> Eius accusantium nes</p> <p>  </p> <p> Metabolism - Issues identified</p> <p> No</p> <p>  </p> <p> Metabolism - Findings</p> <p> Minim laudantium et</p> <p>  </p> <p> Excretion - Issues identified</p> <p> Yes</p> <p>  </p> <p> Excretion - Findings</p> <p> Tempora voluptatum q</p> <p>  </p> <p> Do the ADME studies identify significant concerns?</p> <p> N/A</p> <p>  </p> <p> Major human metabolites were identified</p> <p> No</p> <p>  </p> <p> Unique human metabolites were identified</p> <p> N/A</p> <p>  </p> <p> Absorption, Distribution, Metabolism & Excretion workspace</p> <p> Labore debitis est</p> <p>  </p> <p> Absorption, Distribution, Metabolism & Excretion comments</p> <p> Aut dolore velit cu</p> <p>  </p> <p> Target evaluated - Interaction identified</p> <p> No</p> <p>  </p> <p> Target evaluated - Findings</p> <p> Deserunt delectus a</p> <p>  </p> <p> Enzyme inhibition - Interaction identified</p> <p> No</p> <p>  </p> <p> Enzyme inhibition - Findings</p> <p> Voluptate doloremque</p> <p>  </p> <p> Enzyme induction - Interactioin identified</p> <p> Yes</p> <p>  </p> <p> Enzyme induction - Findings</p> <p> Praesentium dolorum</p> <p>  </p> <p> Transporter - Interaction identified</p> <p> N/A</p> <p>  </p> <p> Transporter - Findings</p> <p> Facere id nisi labor</p> <p>  </p> <p> Co-pathways - Interaction identified</p> <p> Yes</p> <p>  </p> <p> Co-pathways - Findings</p> <p> Sapiente id quia par</p> <p>  </p> <p> Potential for PK drug interactions is indicated at therapeutic dose</p> <p> N/A</p> <p>  </p> <p> The potential interactions have been highlighted to investigators and relevant information is included in the IB/study protocol</p> <p> Yes</p> <p>  </p> <p> Pharmacokinetic drug interactions (Enzymes, Transporter, other) workspace</p> <p> Ducimus sed archite</p> <p>  </p> <p> Pharmacokinetic drug interactions (Enzymes, Transporter, other) comments</p> <p> Yes</p> <p>  </p> <p> Were other PK studies performed?</p> <p> N/A</p> <p>  </p> <p> Do these studies identify concerns?</p> <p> N/A</p> <p>  </p> <p> Other pharmacokinetic studies workspace</p> <p> In mollit obcaecati</p> <p>  </p> <p> Other pharmacokinetic studies comments</p> <p> Doloremque pariatur</p> <p>  </p> <p> Toxicologically relevant animal species studied</p> <p> Yes</p> <p>  </p> <p> The studied species show similar pharmacology to humans</p> <p> Yes</p> <p>  </p> <p> The studied species show similar PK to humans</p> <p> N/A</p> <p>  </p> <p> The studies were sufficiently well-designed</p> <p> No</p> <p>  </p> <p> Animal species selection/Study design workspace</p> <p> Ratione placeat aut</p> <p>  </p> <p> Animal species selection/Study design comments</p> <p> Illo consequat Libe</p> <p>  </p> <p> Species</p> <p> Molestias nulla illu</p> <p>  </p> <p> Dose/ Route</p> <p> Aliquip soluta repre</p> <p>  </p> <p> NO(A)EL/LOEL /MNTD</p> <p> Pariatur Incididunt</p> <p>  </p> <p> Major findings</p> <p> Et enim voluptas dis</p> <p>  </p> <p> Were significant toxicities identified?</p> <p> Yes</p> <p>  </p> <p> Do sufficient margins of exposure exist for planned clinical exposure?</p> <p> Yes</p> <p>  </p> <p> Single dose toxicity workspace</p> <p> Ut rem cum beatae si</p> <p>  </p> <p> Single dose toxicity comments</p> <p> Aut consequatur ali</p> <p>  </p> <p> Study duration</p> <p> Voluptate sint neces</p> <p>  </p> <p> Species</p> <p> Voluptatem Voluptat</p> <p>  </p> <p> Dose/ Route</p> <p> Neque exercitationem</p> <p>  </p> <p> NO(A)EL / LOEL /MNTD</p> <p> Consequatur Deserun</p> <p>  </p> <p> Major findings</p> <p> Molestiae molestiae</p> <p>  </p> <p> Were significant toxicities identified?</p> <p> No</p> <p>  </p> <p> Do sufficient margins of exposure exist for planned clinical exposure?</p> <p> N/A</p> <p>  </p> <p> Does the duration of treatment support the proposed trial duration?</p> <p> Yes</p> <p>  </p> <p> Repeat-dose toxicity workspace</p> <p> Quia a est enim assu</p> <p>  </p> <p> Repeat-dose toxicity comments</p> <p> Velit itaque cupidat</p> <p>  </p> <p> Gene mutations in bacteria - Test system</p> <p> Aspernatur officiis</p> <p>  </p> <p> Gene mutations in bacteria - Results (Positive/Negative/Equivocal)</p> <p> Qui facere culpa mol</p> <p>  </p> <p> In vitro mammalian assay - Test system</p> <p> Vel non dolor evenie</p> <p>  </p> <p> In vitro mammalian assay - Results (Positive/Negative/Equivocal))</p> <p> Veritatis rerum dolo</p> <p>  </p> <p> In vivo genotoxicity test - Test system</p> <p> Fugiat eaque soluta</p> <p>  </p> <p> In vivo genotoxicity test - Results (Positive/Negative/Equivocal)</p> <p> Aut a qui ut non ven</p> <p>  </p> <p> Additional assays - Test system</p> <p> Tempora iusto perspi</p> <p>  </p> <p> Additional assays - (Positive/Negative/Equivocal)</p> <p> Omnis dolore sit ad</p> <p>  </p> <p> Do the submitted data indicate genotoxic potential?</p> <p> Yes</p> <p>  </p> <p> Genotoxicity workspace</p> <p> Delectus iste digni</p> <p>  </p> <p> Genotoxicity comments</p> <p> Nisi nisi delectus</p> <p>  </p> <p> Do studies identify potential for carcinogenicity?</p> <p> No</p> <p>  </p> <p> Do sufficient margins of exposure exist for planned clinical exposure?</p> <p> No</p> <p>  </p> <p> Carcinogenicity workspace</p> <p> Lorem in velit dolor</p> <p>  </p> <p> Carcinogenicity comments</p> <p> Quisquam qui fuga D</p> <p>  </p> <p> Fertility and early embryonic development - Toxicities identified</p> <p> N/A</p> <p>  </p> <p> Fertility and early embryonic development - Findings</p> <p> Quod vero mollitia a</p> <p>  </p> <p> Embryo-fetal development - Toxicities identified</p> <p> N/A</p> <p>  </p> <p> Embryo-fetal development - Findings</p> <p> Et earum quae delect</p> <p>  </p> <p> Prenatal and postnatal development, including maternal function - Toxicities identified</p> <p> N/A</p> <p>  </p> <p> Prenatal and postnatal development, including maternal function - Findings</p> <p> Minus voluptatem ea</p> <p>  </p> <p> Do sufficient margins of exposure exist for planned clinical exposure?</p> <p> No</p> <p>  </p> <p> Reproductive and developmental toxicity - workspace</p> <p> Ipsum ab nostrud pa</p> <p>  </p> <p> Reproductive and developmental toxicity - comments</p> <p> Voluptas cillum comm</p> <p>  </p> <p> The studies used animals in the appropriate age range</p> <p> N/A</p> <p>  </p> <p> The studies identified additional/enhanced juvenile toxicities</p> <p> N/A</p> <p>  </p> <p> Do sufficient margins of exposure exist for planned clinical exposure?</p> <p> Yes</p> <p>  </p> <p> Juvenile toxicity studies workspace</p> <p> Minus odit itaque as</p> <p>  </p> <p> Juvenile toxicity studies comments</p> <p> Lorem ipsam molestia</p> <p>  </p> <p> The studies identified potential toxicities</p> <p> Yes</p> <p>  </p> <p> Do sufficient margins of exposure exist for planned clinical exposure?</p> <p> N/A</p> <p>  </p> <p> Other studies (including enhanced PPND studies) workspace</p> <p> In molestiae sunt e</p> <p>  </p> <p> Add a brief description of the ePPND studies performed in line with ICHS6(R1) and any additional invitro or invivo studies, and the results</p> <p> Consequuntur mollit</p> <p>  </p> <p> Other studies (including enhanced PPND studies) comments</p> <p> Blanditiis labore re</p> <p>  </p> <p> IMP - Suspected/ demonstrated teratogenic or fetotoxic effects</p> <p> N/A</p> <p>  </p> <p> IMP - Genotoxic</p> <p> No</p> <p>  </p> <p> IMP - Insufficient data</p> <p> No</p> <p>  </p> <p> IMP - Demonstrated embryo-fetotoxic effects, which do not seem relevant to the CT participants</p> <p> Yes</p> <p>  </p> <p> IMP - Sufficient data and no indication of risk</p> <p> Yes</p> <p>  </p> <p> Comparator IMP/ auxiliary MP - Suspected or demonstrated</p> <p> Yes</p> <p>  </p> <p> Comparator IMP/ auxiliary MP - teratogenic or fetotoxic</p> <p> No</p> <p>  </p> <p> Comparator IMP/ auxiliary MP - Genotoxic</p> <p> Yes</p> <p>  </p> <p> Comparator IMP/ auxiliary MP - Insufficient data</p> <p> Yes</p> <p>  </p> <p> Comparator IMP/ auxiliary MP - Demonstrated embryo-fetotoxic effects, which do not seem relevant to the CT participants</p> <p> No</p> <p>  </p> <p> Comparator IMP/ auxiliary MP - Sufficient data and no indication of risk</p> <p> Yes</p> <p>  </p> <p> WOCBP1/male partners of WOCBP are included in the proposed clinical trial</p> <p> N/A</p> <p>  </p> <p> According to the guidance issued by the Clinical Trials Facilitation Group on "Recommendations related to contraception and pregnancy testing in clinical trials” the risk of teratogenicity/ fetotoxicity based on the non-clinical data is considered (demonstrated/suspected, possible or unlikely))</p> <p> Dolores vitae fugiat</p> <p>  </p> <p> Recommendations for contraception measures workspace</p> <p> Saepe quia in accusa</p> <p>  </p> <p> Recommendations for contraception measures comments</p> <p> N/A</p> <p>  </p> <p> Do the submitted studies indicate a potential for local toxicity?</p> <p> Yes</p> <p>  </p> <p> Local tolerance workspace</p> <p> Magna commodo exerci</p> <p>  </p> <p> Local tolerance comments</p> <p> Neque iure in quo te</p> <p>  </p> <p> Phototoxicity - Toxicities identified</p> <p> N/A</p> <p>  </p> <p> Phototoxicity - Findings</p> <p> Non tempore adipisc</p> <p>  </p> <p> Tissue cross reactivity - Toxicities identified</p> <p> N/A</p> <p>  </p> <p> Tissue cross reactivity - Findings</p> <p> Reprehenderit atque</p> <p>  </p> <p> Antigenicity - Toxicities identified</p> <p> No</p> <p>  </p> <p> Antigenicity - Findings</p> <p> Repellendus At veli</p> <p>  </p> <p> Immunotoxicity - Toxicities identified</p> <p> No</p> <p>  </p> <p> Immunotoxicity - Findings</p> <p> Aliquip consequuntur</p> <p>  </p> <p> Dependence - Toxicities identified</p> <p> No</p> <p>  </p> <p> Dependence - Findings</p> <p> Ex aspernatur iste n</p> <p>  </p> <p> Metabolites - Toxicities identified</p> <p> N/A</p> <p>  </p> <p> Metabolites - Findings</p> <p> Omnis ad modi rem ut</p> <p>  </p> <p> Impurities - Toxicities identified</p> <p> N/A</p> <p>  </p> <p> Impurities - Findings</p> <p> Sed qui atque commod</p> <p>  </p> <p> Other - Toxicities identified</p> <p> No</p> <p>  </p> <p> Other - Findings</p> <p> Rerum soluta sequi p</p> <p>  </p> <p> Other toxicity studies workspace</p> <p> Officia nisi pariatu</p> <p>  </p> <p> Other toxicity studies comments</p> <p> Magni omnis et sunt</p> <p>  </p> <p> Is the starting dose adequately justified?</p> <p> N/A</p> <p>  </p> <p> Are the dose steps adequately justified?</p> <p> No</p> <p>  </p> <p> Is the maximum dose adequately justified?</p> <p> Yes</p> <p>  </p> <p> Additional Considerations workspace</p> <p> Quibusdam in velit</p> <p>  </p> <p> Additional Considerations comments</p> <p> Nam rerum laudantium</p> <p>  </p> <p> Were all pivotal safety studies performed in line with the good laboratory practices (GLP) of the Organization for Economic Cooperation and Development? Were the studies performed in a country that is a member of OECD Mutual Acceptance of Data (MAD) for GLP?</p> <p> Yes</p> <p>  </p> <p> GLP aspects workspace</p> <p> Explicabo Irure lab</p> <p>  </p> <p> GLP aspects comments</p> <p> Porro ab quae quas a</p> <p>  </p> <p> The non-clinical data provided are acceptable</p> <p> N/A</p> <p>  </p> <p> Supplementary information needs to be provided (refer to the list of requests for additional information)</p> <p> Yes</p> <p>  </p> <p> Overall comment/ conclusion on the non-clinical assessment</p> <p> Hic et fuga Asperna</p> <p>  </p> <p> 1.7.1 REQUESTS FOR ADDITIONAL INFORMATION: NON-CLINICAL</p> <p> Fugit quos a nisi s</p> <p>  </p>
      • recommendation<p> Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>
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      • summary<p> 1.1 Introduction</p> <p> Dolores et id vel v</p> <p>  </p> <p> The pharmacology studies provide the pharmacological basis for the proposed trial</p> <p> No</p> <p>  </p> <p> Were relevant in vitro and/or in vivo models studied?</p> <p> No</p> <p>  </p> <p> Is the intended pharmacological effect expected/ possible at clinical exposure?</p> <p> No</p> <p>  </p> <p> Were pharmacologically active major metabolites identified?</p> <p> N/A</p> <p>  </p> <p> Is the IMP a first-in-class compound?</p> <p> No</p> <p>  </p> <p> Primary pharmacodynamics workspace</p> <p> Obcaecati eum adipis</p> <p>  </p> <p> Primary pharmacodynamics comments</p> <p> Ut magni ad deleniti</p> <p>  </p> <p> The studies described in this section identified off-target effects</p> <p> N/A</p> <p>  </p> <p> Are off-target effects expected / possible at clinical exposure?</p> <p> No</p> <p>  </p> <p> Secondary pharmacodynamics workspace</p> <p> Quis amet sit ulla</p> <p>  </p> <p> Secondary pharmacodynamics comments</p> <p> Ea atque quod optio</p> <p>  </p> <p> Cardiovascular - Study type</p> <p> Tempore dolorem ita</p> <p>  </p> <p> Cardiovascular - Issues identified</p> <p> N/A</p> <p>  </p> <p> Cardiovascular - Major findings</p> <p> Nostrum non cupidita</p> <p>  </p> <p> Respiratory - Study type</p> <p> Laboriosam molestia</p> <p>  </p> <p> Respiratory - Issues identified</p> <p> No</p> <p>  </p> <p> Respiratory - Major findings</p> <p> Yes</p> <p>  </p> <p> CNS - Study type</p> <p> Aspernatur voluptatu</p> <p>  </p> <p> CNS - Issues identified</p> <p> N/A</p> <p>  </p> <p> CNS - Major findings</p> <p> Yes</p> <p>  </p> <p> Other - Study type</p> <p> Et laborum recusanda</p> <p>  </p> <p> Other - Issues identified</p> <p> No</p> <p>  </p> <p> Other - Major findings</p> <p> No</p> <p>  </p> <p> Did the safety pharmacology studies identify significant concerns?</p> <p> Yes</p> <p>  </p> <p> Do sufficient margins of exposure exist for planned clinical exposure?</p> <p> N/A</p> <p>  </p> <p> Safety pharmacology workspace</p> <p> Dolore impedit offi</p> <p>  </p> <p> Safety pharmacology comments</p> <p> Yes</p> <p>  </p> <p> Have potential pharmacodynamics drug interactions been identified?</p> <p> Yes</p> <p>  </p> <p> Pharmacodynamic drug interactions workspace</p> <p> Ea sint saepe recusa</p> <p>  </p> <p> Pharmacodynamic drug interactions comments</p> <p> Quia aute excepturi</p> <p>  </p> <p> Are the methods of analysis and their sensitivities adequate?</p> <p> Yes</p> <p>  </p> <p> Pharmacokinetics workspace</p> <p> Maxime rem quaerat e</p> <p>  </p> <p> Pharmacokinetics comments</p> <p> Enim illo ducimus v</p> <p>  </p> <p> Absorption - Issues identified</p> <p> N/A</p> <p>  </p> <p> Absorption - Findings</p> <p> Vitae dolor autem al</p> <p>  </p> <p> Distribution - Issues identified</p> <p> N/A</p> <p>  </p> <p> Distribution - Findings</p> <p> Eius accusantium nes</p> <p>  </p> <p> Metabolism - Issues identified</p> <p> No</p> <p>  </p> <p> Metabolism - Findings</p> <p> Minim laudantium et</p> <p>  </p> <p> Excretion - Issues identified</p> <p> Yes</p> <p>  </p> <p> Excretion - Findings</p> <p> Tempora voluptatum q</p> <p>  </p> <p> Do the ADME studies identify significant concerns?</p> <p> N/A</p> <p>  </p> <p> Major human metabolites were identified</p> <p> No</p> <p>  </p> <p> Unique human metabolites were identified</p> <p> N/A</p> <p>  </p> <p> Absorption, Distribution, Metabolism & Excretion workspace</p> <p> Labore debitis est</p> <p>  </p> <p> Absorption, Distribution, Metabolism & Excretion comments</p> <p> Aut dolore velit cu</p> <p>  </p> <p> Target evaluated - Interaction identified</p> <p> No</p> <p>  </p> <p> Target evaluated - 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Suspected/ demonstrated teratogenic or fetotoxic effects</p> <p> N/A</p> <p>  </p> <p> IMP - Genotoxic</p> <p> No</p> <p>  </p> <p> IMP - Insufficient data</p> <p> No</p> <p>  </p> <p> IMP - Demonstrated embryo-fetotoxic effects, which do not seem relevant to the CT participants</p> <p> Yes</p> <p>  </p> <p> IMP - Sufficient data and no indication of risk</p> <p> Yes</p> <p>  </p> <p> Comparator IMP/ auxiliary MP - Suspected or demonstrated</p> <p> Yes</p> <p>  </p> <p> Comparator IMP/ auxiliary MP - teratogenic or fetotoxic</p> <p> No</p> <p>  </p> <p> Comparator IMP/ auxiliary MP - Genotoxic</p> <p> Yes</p> <p>  </p> <p> Comparator IMP/ auxiliary MP - Insufficient data</p> <p> Yes</p> <p>  </p> <p> Comparator IMP/ auxiliary MP - Demonstrated embryo-fetotoxic effects, which do not seem relevant to the CT participants</p> <p> No</p> <p>  </p> <p> Comparator IMP/ auxiliary MP - Sufficient data and no indication of risk</p> <p> Yes</p> <p>  </p> <p> WOCBP1/male partners of WOCBP are included in the proposed clinical trial</p> <p> N/A</p> <p>  </p> <p> According to the guidance issued by the Clinical Trials Facilitation Group on "Recommendations related to contraception and pregnancy testing in clinical trials” the risk of teratogenicity/ fetotoxicity based on the non-clinical data is considered (demonstrated/suspected, possible or unlikely))</p> <p> Dolores vitae fugiat</p> <p>  </p> <p> Recommendations for contraception measures workspace</p> <p> Saepe quia in accusa</p> <p>  </p> <p> Recommendations for contraception measures comments</p> <p> N/A</p> <p>  </p> <p> Do the submitted studies indicate a potential for local toxicity?</p> <p> Yes</p> <p>  </p> <p> Local tolerance workspace</p> <p> Magna commodo exerci</p> <p>  </p> <p> Local tolerance comments</p> <p> Neque iure in quo te</p> <p>  </p> <p> Phototoxicity - 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      • recommendation<p> Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>
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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>PPB/ECCT/26/02/02/2026(5)                                                                                                                                                                             23rd March 2026</strong></span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><strong>Molly White Kalia Stanley Samuel Rollins,</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/26/02/02,</strong></span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><strong>Nisi magna rerum consequatur deleniti voluptate dignissimos numquam sit sit ex est maxime,</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/26/02/02 : Initial Approval; Qui exercitation ut officia ob  :short_title</u></strong></span><strong style="font-family: "bookman old style", serif;"><u>.</u></strong></span></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="http://45.79.161.190:8080/attachments/download/2319">screenshot_2026_02_13_at_15_33_12_13.png</a> dated 23rd February 2026 Version 1<br>2. The Study Protocol<br><a href="http://45.79.161.190:8080/attachments/download/2320">screenshot_2026_02_13_at_15_33_12_14.png</a> dated 23rd February 2026 Version 1<br>3. Patient Information leaflet and Informed consent form<br><a href="http://45.79.161.190:8080/attachments/download/2321">screenshot_2026_02_13_at_15_33_12_15.png</a> dated 23rd February 2026 Version 1<br>4. Investigators Brochure/Package inserts<br><a href="http://45.79.161.190:8080/attachments/download/2322">screenshot_2026_02_13_at_15_33_12_16.png</a> dated 23rd February 2026 Version 1<br>5. GMP certificate of the investigational product from the site of manufacture<br><a href="http://45.79.161.190:8080/attachments/download/2323">screenshot_2026_02_13_at_15_33_12_17.png</a> dated 23rd February 2026 Version 1<br>6. 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="http://45.79.161.190:8080/attachments/download/2324">screenshot_2026_02_13_at_15_33_12_18.png</a> dated 23rd February 2026 Version 1<br>7. Financial declaration by Sponsor and/or PI <a href="http://45.79.161.190:8080/attachments/export/1736">click here</a><br><a href="http://45.79.161.190:8080/attachments/download/2325">screenshot_2026_02_13_at_15_33_12_19.png</a> dated 23rd February 2026 Version 1<br>8. Signed Declaration by Sponsor or Principal investigator that the study will be carried out according to the protocol and applicable laws, regulations and GCP requirements. <a href="http://45.79.161.190:8080/attachments/export/1732"> click here </a><br><a href="http://45.79.161.190:8080/attachments/download/2326">screenshot_2026_02_13_at_15_33_12_20.png</a> dated 23rd February 2026 Version 1<br>9. Clinical Trials Insurance cover for study participants<br><a href="http://45.79.161.190:8080/attachments/download/2327">screenshot_2026_02_13_at_15_33_12_21.png</a> dated 23rd February 2026 Version 1<br>10. Copy of favorable opinion letter from the local Ethics Review Committee (ERC).<br><a href="http://45.79.161.190:8080/attachments/download/2328">screenshot_2026_02_13_at_15_33_12_22.png</a> dated 23rd February 2026 Version 1<br>11. 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="http://45.79.161.190:8080/attachments/download/2329">screenshot_2026_02_13_at_15_33_12_23.png</a> dated 23rd February 2026 Version 1<br>12. Payment of fees<br><a href="http://45.79.161.190:8080/attachments/download/2330">screenshot_2026_02_13_at_15_33_12_24.png</a> dated 23rd February 2026 Version 1<br></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>        :reviewer_summary_comments</strong></span></p> <p> <span style="font-size:12px;">The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study: Qui exercitation ut officia ob ECCT/26/02/02<strong>.</strong></span></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>23rd March 2027</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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  • SiteInspection(empty)
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  • Ciom(empty)
  • StudyRoute(array)
    • 0(array)
      • id163
      • application_id248
      • study_routeintradermal
      • created2020-08-04 12:09:54
      • modified2026-02-25 12:07:29
  • Manufacturer(array)
    • 0(array)
      • id74
      • application_id248
      • manufacturer_nameThane Dale
      • addressDolore ipsum qui cum quia repellendus Pariatur Veniam velit quis odio consequatur natus dolore ex quis
      • manufacturer_countryCzech Republic
      • manufacturer_phone+1 (107) 635-7943
      • manufacturer_emailpiqy@mailinator.com
      • manufacturing_activitiesStability testing
      • other_specifyFugiat voluptate nulla aperiam sapiente iste
      • created2026-02-23 07:01:57
      • modified2026-02-25 12:07:29
  • Reassignment(empty)
  • Attachment(empty)
  • AnnualApproval(empty)
  • AmendmentChecklist(empty)
  • Reminder(empty)
  • ParticipantFlow(empty)
  • Budget(array)
    • 0(array)
      • id74
      • application_id248
      • year(null)
      • budget_period(null)
      • personnel_currencyEUR
      • personnelNatus quide
      • transport_currencyEUR
      • transportA quidem in
      • field_currencyEUR
      • fieldEx consequa
      • supplies_currencyUSD
      • suppliesEst cillum
      • pharmacy_currencyEUR
      • pharmacyLabore volu
      • travel_currencyUSD
      • travelOdio aliqua
      • regulatory_currencyUSD
      • regulatoryDeserunt be
      • it_currencyKES
      • itQuidem amet
      • lab_currency(null)
      • lab(null)
      • others_currencyUSD
      • othersEnim sit n
      • kemri_currency(null)
      • kemri(null)
      • wrair_currency(null)
      • wrair(null)
      • subject_currencyEUR
      • subjectVoluptatem
      • grand_currencyUSD
      • grand_totalDoloremque
      • study_informationUt quisquam nesciunt
      • personnel_kshsError alias
      • transport_kshsEt id ex m
      • field_kshsFugiat omn
      • supplies_kshsOmnis eveni
      • pharmacy_kshsVeniam in
      • travel_kshsAut volupta
      • regulatory_kshsMollit quod
      • it_kshsQuidem in d
      • lab_kshs(null)
      • others_kshsEaque proid
      • grand_total_kshsEiusmod adi
      • subject_kshsVel velit m
      • created2026-02-23 07:01:57
      • modified2026-02-25 12:07:29
  • 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)
      • id2319
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_2026_02_13_at_15_33_12_13.png
      • foreign_key248
      • dirnameimg
      • basenamescreenshot_2026_02_13_at_15_33_12_13.png
      • checksum398174e579e99024b8b47121b96fa310
      • alternative(null)
      • groupapplicant_covering_letter
      • descriptionCover Letter (Should list all the submitted documents, their version numbers and dates) *
      • year(null)
      • file_date23-02-2026
      • pocket_nameapplicant_covering_letter
      • version_no1
      • created2026-02-23 06:58:59
      • modified2026-02-25 12:07:29
      • pathimg/screenshot_2026_02_13_at_15_33_12_13.png
    • 1(array)
      • id2320
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_2026_02_13_at_15_33_12_14.png
      • foreign_key248
      • dirnameimg
      • basenamescreenshot_2026_02_13_at_15_33_12_14.png
      • checksum398174e579e99024b8b47121b96fa310
      • alternative(null)
      • groupapplicant_protocol
      • descriptionThe Study Protocol *
      • year(null)
      • file_date23-02-2026
      • pocket_nameapplicant_protocol
      • version_no1
      • created2026-02-23 06:59:07
      • modified2026-02-23 06:59:07
      • pathimg/screenshot_2026_02_13_at_15_33_12_14.png
    • 2(array)
      • id2321
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_2026_02_13_at_15_33_12_15.png
      • foreign_key248
      • dirnameimg
      • basenamescreenshot_2026_02_13_at_15_33_12_15.png
      • checksum398174e579e99024b8b47121b96fa310
      • alternative(null)
      • groupapplicant_patient_information
      • descriptionPatient Information leaflet and Informed consent form *
      • year(null)
      • file_date23-02-2026
      • pocket_nameapplicant_patient_information
      • version_no1
      • created2026-02-23 06:59:21
      • modified2026-02-23 06:59:21
      • pathimg/screenshot_2026_02_13_at_15_33_12_15.png
    • 3(array)
      • id2322
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_2026_02_13_at_15_33_12_16.png
      • foreign_key248
      • dirnameimg
      • basenamescreenshot_2026_02_13_at_15_33_12_16.png
      • checksum398174e579e99024b8b47121b96fa310
      • alternative(null)
      • groupapplicant_investigators_brochure
      • descriptionInvestigators Brochure/Package inserts *
      • year(null)
      • file_date23-02-2026
      • pocket_nameapplicant_investigators_brochure
      • version_no1
      • created2026-02-23 07:00:38
      • modified2026-02-23 07:00:38
      • pathimg/screenshot_2026_02_13_at_15_33_12_16.png
    • 4(array)
      • id2323
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_2026_02_13_at_15_33_12_17.png
      • foreign_key248
      • dirnameimg
      • basenamescreenshot_2026_02_13_at_15_33_12_17.png
      • checksum398174e579e99024b8b47121b96fa310
      • alternative(null)
      • groupapplicant_gmp_certificate
      • descriptionGMP certificate of the investigational product from the site of manufacture *
      • year(null)
      • file_date23-02-2026
      • pocket_nameapplicant_gmp_certificate
      • version_no1
      • created2026-02-23 07:00:49
      • modified2026-02-23 07:00:49
      • pathimg/screenshot_2026_02_13_at_15_33_12_17.png
    • 5(array)
      • id2324
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_2026_02_13_at_15_33_12_18.png
      • foreign_key248
      • dirnameimg
      • basenamescreenshot_2026_02_13_at_15_33_12_18.png
      • checksum398174e579e99024b8b47121b96fa310
      • 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_date23-02-2026
      • pocket_nameapplicant_investigators_cv
      • version_no1
      • created2026-02-23 07:00:58
      • modified2026-02-23 07:00:58
      • pathimg/screenshot_2026_02_13_at_15_33_12_18.png
    • 6(array)
      • id2325
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_2026_02_13_at_15_33_12_19.png
      • foreign_key248
      • dirnameimg
      • basenamescreenshot_2026_02_13_at_15_33_12_19.png
      • checksum398174e579e99024b8b47121b96fa310
      • alternative(null)
      • groupapplicant_financial_declaration
      • descriptionFinancial declaration by Sponsor and/or PI click here *
      • year(null)
      • file_date23-02-2026
      • pocket_nameapplicant_financial_declaration
      • version_no1
      • created2026-02-23 07:01:07
      • modified2026-02-23 07:01:07
      • pathimg/screenshot_2026_02_13_at_15_33_12_19.png
    • 7(array)
      • id2326
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_2026_02_13_at_15_33_12_20.png
      • foreign_key248
      • dirnameimg
      • basenamescreenshot_2026_02_13_at_15_33_12_20.png
      • checksum398174e579e99024b8b47121b96fa310
      • 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. click here *
      • year(null)
      • file_date23-02-2026
      • pocket_nameapplicant_signed_declaration
      • version_no1
      • created2026-02-23 07:01:16
      • modified2026-02-23 07:01:16
      • pathimg/screenshot_2026_02_13_at_15_33_12_20.png
    • 8(array)
      • id2327
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_2026_02_13_at_15_33_12_21.png
      • foreign_key248
      • dirnameimg
      • basenamescreenshot_2026_02_13_at_15_33_12_21.png
      • checksum398174e579e99024b8b47121b96fa310
      • alternative(null)
      • groupapplicant_indemnity_cover
      • descriptionClinical Trials Insurance cover for study participants *
      • year(null)
      • file_date23-02-2026
      • pocket_nameapplicant_indemnity_cover
      • version_no1
      • created2026-02-23 07:01:25
      • modified2026-02-23 07:01:25
      • pathimg/screenshot_2026_02_13_at_15_33_12_21.png
    • 9(array)
      • id2328
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_2026_02_13_at_15_33_12_22.png
      • foreign_key248
      • dirnameimg
      • basenamescreenshot_2026_02_13_at_15_33_12_22.png
      • checksum398174e579e99024b8b47121b96fa310
      • alternative(null)
      • groupapplicant_opinion_letter
      • descriptionCopy of favorable opinion letter from the local Ethics Review Committee (ERC). *
      • year(null)
      • file_date23-02-2026
      • pocket_nameapplicant_opinion_letter
      • version_no1
      • created2026-02-23 07:01:35
      • modified2026-02-23 07:01:35
      • pathimg/screenshot_2026_02_13_at_15_33_12_22.png
    • 10(array)
      • id2329
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_2026_02_13_at_15_33_12_23.png
      • foreign_key248
      • dirnameimg
      • basenamescreenshot_2026_02_13_at_15_33_12_23.png
      • checksum398174e579e99024b8b47121b96fa310
      • 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_date23-02-2026
      • pocket_nameapplicant_statement
      • version_no1
      • created2026-02-23 07:01:44
      • modified2026-02-23 07:01:44
      • pathimg/screenshot_2026_02_13_at_15_33_12_23.png
    • 11(array)
      • id2330
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_2026_02_13_at_15_33_12_24.png
      • foreign_key248
      • dirnameimg
      • basenamescreenshot_2026_02_13_at_15_33_12_24.png
      • checksum398174e579e99024b8b47121b96fa310
      • alternative(null)
      • groupapplicant_fees
      • descriptionPayment of fees *
      • year(null)
      • file_date23-02-2026
      • pocket_nameapplicant_fees
      • version_no1
      • created2026-02-23 07:01:53
      • modified2026-02-23 07:01:57
      • pathimg/screenshot_2026_02_13_at_15_33_12_24.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)
  • InternalReview(empty)
  • ActiveInspector(empty)
  • ManagerReview(empty)
  • Acceptance(empty)
  • Amendment(empty)
  • InvestigatorContact(empty)
  • ApplicationStage(empty)
  • Pharmacist(empty)
  • EthicalCommittee(empty)
  • AnnualLetter(empty)
  • AmendmentLetter(empty)
  • AmendmentApproval(empty)
  • AmendmentApprovalSummary(empty)
  • Organization(empty)
  • SiteDetail(empty)
  • Placebo(empty)
  • Sponsor(empty)
  • SiteInspection(empty)
  • Sae(empty)
  • Ciom(empty)
  • StudyRoute(empty)
  • Manufacturer(empty)
  • Reassignment(empty)
  • Attachment(empty)
  • AnnualApproval(empty)
  • AmendmentChecklist(empty)
  • Reminder(empty)
  • ParticipantFlow(empty)
  • Budget(empty)
  • Deviation(empty)
  • Document(empty)
  • CoverLetter(empty)
  • Protocol(empty)
  • PatientLeaflet(empty)
  • Brochure(empty)
  • GmpCertificate(empty)
  • Cv(empty)
  • Finance(empty)
  • Declaration(empty)
  • IndemnityCover(empty)
  • OpinionLetter(empty)
  • ApprovalLetter(empty)
  • Statement(empty)
  • ParticipatingStudy(empty)
  • Addendum(empty)
  • Registration(empty)
  • Fee(empty)
  • Checklist(empty)
  • StudyMonitor(empty)
  • ProtocolOutsource(empty)
  • Outsource(empty)
• Loaded Helpers(array)
  • 0Html
  • 1Form
  • 2Session
  • 3Text
  • 4Number
  • 5SimpleGraph
  • 6DebugTimer
  • 7Toolbar
  • 8HtmlToolbar

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