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View Variables

• application(array)
  • Application(array)
    • id127
    • user_id26
    • application_id(null)
    • is_child0
    • trial_status_id7
    • total_sites3
    • abstract_of_study<p> test</p>
    • study_title<p> Laborum Doloribus illo impedi</p>
    • laymans_summary<p> test</p>
    • short_titleLaborum Doloribus illo impedi
    • protocol_noECCT/25/01/01
    • reference_no
    • version_noEt duis deserunt tempor blanditiis omnis cum distinctio
    • date_of_protocol15-01-1977
    • study_drugOccaecat quidem sunt officia adipisci aperiam reprehenderit illo error culpa atque ut voluptas sit vero
    • disease_conditionImpedit eaque facilis dignissimos magni dolorem sit dolore in quia modi cumque dicta
    • product_type_biologicals0
    • product_type_proteins0
    • product_type_immunologicals1
    • product_type_vaccines0
    • product_type_hormones1
    • product_type_toxoid0
    • product_type_chemical0
    • product_type_medical_device1
    • product_type_chemical_nameAmela Wiley
    • product_type_medical_device_nameMiranda Fry
    • comparatorYes
    • comparator_nameHolmes Tanner
    • comparator_registeredEnim aperiam incidunt est ut
    • comparator_countriesDeserunt eiusmod ver
    • ecct_not_applicable0
    • ecct_ref_number
    • email_addressqimuvo@mailinator.com
    • applicant_covering_letter1
    • applicant_protocol1
    • applicant_patient_information1
    • applicant_investigators_brochure1
    • applicant_investigators_cv1
    • applicant_signed_declaration1
    • applicant_financial_declaration1
    • applicant_gmp_certificate1
    • applicant_indemnity_cover1
    • applicant_opinion_letter1
    • applicant_approval_letter1
    • applicant_statement1
    • applicant_participating_countries(null)
    • applicant_addendum1
    • applicant_fees1
    • applicant_complete_form(null)
    • applicant_impd1
    • applicant_prev_data1
    • applicant_stability_data1
    • applicant_analysis_cert1
    • applicant_pictorial_sample1
    • applicant_gcp_training1
    • applicant_dsmb_charter1
    • applicant_detailed_budget1
    • applicant_indemnity_pi1
    • applicant_practice_license1
    • applicant_registration_ctr(null)
    • applicant_pan_african1
    • applicant_hard_copies(null)
    • applicant_signed_checklist1
    • statistical_analysis_plan1
    • applicant_contractual_agreement0
    • declaration_applicantUnde lorem aut expedita sed assumenda sint qui cupiditate
    • declaration_date108-12-2013
    • declaration_principal_investigatorError tempor odit dicta aute perferendis autem cum doloribus omnis odio quaerat nihil reiciendis quasi eos minima itaque
    • declaration_date207-01-2025
    • placebo_presentYes
    • study_objectives<p> test</p>
    • principal_inclusion_criteria<p> test</p>
    • principal_exclusion_criteria<p> test</p>
    • primary_end_points<p> test</p>
    • scope_diagnosis1
    • scope_prophylaxis0
    • scope_therapy1
    • scope_safety1
    • scope_efficacy0
    • scope_pharmacokinetic0
    • scope_pharmacodynamic1
    • scope_bioequivalence0
    • scope_dose_response0
    • scope_pharmacogenetic0
    • scope_pharmacogenomic1
    • scope_pharmacoecomomic0
    • scope_others0
    • scope_others_specify
    • trial_human_pharmacology1
    • trial_administration_humans0
    • trial_bioequivalence_study1
    • trial_other0
    • trial_other_specify
    • trial_therapeutic_exploratory1
    • trial_therapeutic_confirmatory1
    • trial_therapeutic_use0
    • design_controlledNo
    • site_capacity(null)
    • staff_numbers<p> test</p>
    • other_details_explanation<p> test</p>
    • other_details_regulatory_notapproved<p> tets</p>
    • other_details_regulatory_approved<p> test</p>
    • other_details_regulatory_rejected<p> tets</p>
    • other_details_regulatory_halted<p> test</p>
    • estimated_durationEx qui assumenda laudantium eos dolor voluptatem Quaerat vero ut ex voluptatem corporis neque laborum Irure
    • design_controlled_randomised
    • design_controlled_open
    • design_controlled_single_blind
    • design_controlled_double_blind
    • design_controlled_parallel_group
    • design_controlled_cross_over
    • design_controlled_other
    • design_controlled_specify
    • design_controlled_comparator
    • design_controlled_other_medicinal
    • design_controlled_placebo
    • design_controlled_medicinal_other
    • design_controlled_medicinal_specify
    • single_site_member_stateNo
    • location_of_area
    • single_site_physical_address
    • single_site_contact_person
    • single_site_telephone
    • multiple_sites_member_stateYes
    • multiple_countriesYes
    • multiple_member_states20
    • number_of_sites2
    • multi_country_listEos aute voluptatem
    • data_monitoring_committeeNo
    • total_enrolment_per_site200
    • total_participants_worldwideVoluptatem incididunt nostrud sint error nobis itaque nisi enim
    • population_less_than_18_yearsYes
    • population_uteroNo
    • population_preterm_newbornYes
    • population_newbornYes
    • population_infant_and_toddlerYes
    • population_childrenYes
    • population_adolescentNo
    • population_above_18Yes
    • population_adultYes
    • population_elderlyNo
    • gender_female0
    • gender_male1
    • subjects_healthyYes
    • subjects_patientsNo
    • subjects_vulnerable_populationsYes
    • subjects_women_child_bearingNo
    • subjects_women_using_contraceptionYes
    • subjects_pregnant_womenYes
    • subjects_nursing_womenUnclear
    • subjects_emergency_situationYes
    • subjects_incapable_consentYes
    • subjects_specifyLabore quae cum qui
    • subjects_othersYes
    • subjects_others_specifyVoluptate qui sed al
    • investigator1_given_nameRemedios Steele
    • investigator1_middle_nameTaShya Moore
    • investigator1_family_nameBrady Key
    • investigator1_qualificationEveniet laudantium doloremque provident illo maiores asperiores animi totam reiciendis corporis est
    • investigator1_professional_addressVoluptatibus voluptates nemo sit et lorem
    • investigator1_telephone+1 (974) 807-5529
    • investigator1_emailcuvicenuwy@mailinator.com
    • organisations_transferred_No
    • number_participants20000
    • notification<p> test</p>
    • approval_date07-01-2025
    • submitted1
    • deleted0
    • deleted_date(null)
    • deactivated0
    • date_submitted07-01-2025
    • unsubmitted1
    • initial_date_submitted07-01-2025
    • admin_stopped0
    • admin_stopped_reason(null)
    • approved2
    • approved_reasontest
    • 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_invoice343770
    • modified2025-02-18 08:53:19
    • created2025-01-06 15:07:01
  • User(array)
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    • usernamejavan
    • passwordee68d9627812445cb0ccfd02e319d77ad0f9f4c9
    • confirm_passwordee68d9627812445cb0ccfd02e319d77ad0f9f4c9
    • nameJavan
    • emailjayoma@intellisoftkenya.com
    • national_id_number89019283
    • sponsor(null)
    • sponsor_emailjayoma@intellisoftkenya.com
    • qualificationtest
    • phone_no+254702674563
    • name_of_institutiontest
    • institution_physicaltest street
    • institution_addresstest address
    • institution_contacttest contacts
    • county_id47
    • country_id115
    • group_id5
    • activation_key
    • forgot_password(null)
    • is_active1
    • deactivated0
    • created2024-01-17 15:58:25
    • modified2024-05-21 07:37:41
  • TrialStatus(array)
    • id7
    • valueAnalysing
    • nameAnalysing
    • created2013-10-07 18:21:02
    • modified2013-10-07 18:21:02
  • Review(array)
    • 0(array)
      • id15
      • user_id2
      • application_id127
      • typeppb_comment
      • assessment_type(null)
      • title(null)
      • text<p> manager comments</p>
      • summary(null)
      • recommendation<p> Managers recommendations</p>
      • notified0
      • accepted(null)
      • conflict(null)
      • statusUnsubmitted
      • created2025-01-07 08:51:31
      • modified2025-01-07 08:51:31
    • 1(array)
      • id19
      • user_id84
      • application_id127
      • typerequest
      • assessment_type(null)
      • titlePPB request
      • text
      • summary(null)
      • recommendationttest message
      • notified0
      • acceptedaccepted
      • conflictNo
      • statusUnsubmitted
      • created2025-01-07 10:17:34
      • modified2025-01-07 10:18:32
    • 2(array)
      • id21
      • user_id2
      • application_id127
      • typeppb_comment
      • assessment_type(null)
      • title(null)
      • text<p> The Role of Cybersecurity in Modern Organizations</p> <h4> Importance of Cybersecurity</h4> <p> In today's digital age, organizations rely heavily on technology to manage operations, store sensitive data, and connect with customers. This dependency on digital infrastructure has made cybersecurity a crucial aspect of business continuity, protecting against data breaches, cyberattacks, and other security threats.</p> <h4> Emerging Threats in Cyberspace</h4> <p> With the rapid evolution of cyber threats, including ransomware, phishing attacks, and advanced persistent threats, organizations face challenges in keeping their systems secure. These threats are becoming more sophisticated, targeting critical industries such as healthcare, finance, and government.</p> <h4> Strategies for Effective Cyber Defense</h4> <p> To mitigate these risks, companies must adopt robust security measures such as multi-factor authentication, endpoint detection, and encryption. Training employees on security best practices and conducting regular risk assessments are also essential in creating a proactive security culture.</p> <h4> Future of Cybersecurity</h4> <p> As the digital landscape continues to evolve, so must cybersecurity strategies. Innovations like artificial intelligence and machine learning are paving the way for more efficient threat detection and response systems. By staying ahead of trends, organizations can secure their assets and build trust with stakeholders.</p>
      • summary(null)
      • recommendation<p> The Role of Cybersecurity in Modern Organizations</p> <h4> Importance of Cybersecurity</h4> <p> In today's digital age, organizations rely heavily on technology to manage operations, store sensitive data, and connect with customers. This dependency on digital infrastructure has made cybersecurity a crucial aspect of business continuity, protecting against data breaches, cyberattacks, and other security threats.</p> <h4> Emerging Threats in Cyberspace</h4> <p> With the rapid evolution of cyber threats, including ransomware, phishing attacks, and advanced persistent threats, organizations face challenges in keeping their systems secure. These threats are becoming more sophisticated, targeting critical industries such as healthcare, finance, and government.</p> <h4> Strategies for Effective Cyber Defense</h4> <p> To mitigate these risks, companies must adopt robust security measures such as multi-factor authentication, endpoint detection, and encryption. Training employees on security best practices and conducting regular risk assessments are also essential in creating a proactive security culture.</p> <h4> Future of Cybersecurity</h4> <p> As the digital landscape continues to evolve, so must cybersecurity strategies. Innovations like artificial intelligence and machine learning are paving the way for more efficient threat detection and response systems. By staying ahead of trends, organizations can secure their assets and build trust with stakeholders.</p>
      • notified0
      • accepted(null)
      • conflict(null)
      • statusUnsubmitted
      • created2025-01-08 15:20:26
      • modified2025-01-08 15:20:26
    • 3(array)
      • id23
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      • application_id127
      • typeppb_comment
      • assessment_type(null)
      • title(null)
      • text<p> test password</p>
      • summary(null)
      • recommendation<p> test password</p>
      • notified0
      • accepted(null)
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      • statusUnsubmitted
      • created2025-01-09 12:56:28
      • modified2025-01-09 12:56:28
    • 4(array)
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      • user_id3
      • application_id127
      • typerequest
      • assessment_type(null)
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      • text
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      • recommendation
      • notified0
      • acceptedaccepted
      • conflictNo
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      • created2025-01-09 13:18:12
      • modified2025-01-09 13:19:04
    • 5(array)
      • id51
      • user_id83
      • application_id127
      • typerequest
      • assessment_type(null)
      • titlePPB request
      • text
      • summary(null)
      • recommendation
      • notified0
      • acceptedaccepted
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      • created2025-02-17 09:04:57
      • modified2025-02-17 09:33:46
    • 6(array)
      • id55
      • user_id3
      • application_id127
      • typereviewer_comment
      • assessment_typeclinical
      • title(null)
      • text(null)
      • summary<p> <strong>Trial category workspace</strong><br /> Rerum labore atque c<br /> <br /> <strong>Trial category comments</strong><br /> Aliquam nihil dolore<br /> <br /> <strong>Trial phase workspace</strong><br /> Ipsam nemo nulla sae<br /> <br /> <strong>Trial phase comments (if in disagreement with the study phase proposed): </strong><br /> Magni non tempore d<br /> <br /> <strong>Therapeutic condition workspace</strong><br /> Minus accusantium qu<br /> <br /> <strong>Brief description of the disease</strong><br /> Adipisci vero duis c<br /> <br /> <strong>Brief discussion of clinical pharmacokinetic data, efficacy and safety data described in the IB from previous trials /previously investigated indications(s) for the IMP(s). Non-clinical studies may also be discussed for early or FIH clinical trials. Consideration should be given to the justification provided based on the non-clinical data, for the proposed starting dose, dose steps, and maximum exposure</strong><br /> At fugiat laudantiu<br /> <br /> <strong>Assessor’s discussion on the clinical development:</strong><br /> Dicta dolore consequ<br /> <br /> <strong>Consider what is new in this trial, the clinical relevance, and the medical need that the trial aims to address</strong><br /> Odit minim doloremqu<br /> <br /> <strong>Clinical Trial Rationale comments</strong><br /> Veritatis suscipit d<br /> <br /> <strong>Consider if there are established primary endpoints for this type of study/indication, do they match the goals, are they validated?</strong><br /> Fugiat fugiat illo<br /> <br /> <strong>Primary objectives comments</strong><br /> Nobis laborum illo i<br /> <br /> <strong>Secondary objectives workspace</strong><br /> Nam sed officiis ver<br /> <br /> <strong>Secondary objectives comments</strong><br /> Minim ab nobis dolor<br /> <br /> <strong>Study population workspace</strong><br /> Voluptates vitae qua<br /> <br /> <strong>Study population comments</strong><br /> Velit impedit ea eu<br /> <br /> <strong>Take also into consideration the gender and age allocation of participants, and determine whether a specific group is excluded or underrepresented</strong><br /> Voluptatem Et quod<br /> <br /> <strong>Inclusion criteria comments</strong><br /> Quia quis suscipit v<br /> <br /> <strong>Check if a justification is provided in the event that a specific group is excluded or underrepresented Applicable for registered products, consider the contraindications included in the SmPC for the investigational medical product, comparator, and auxiliary medical products</strong><br /> Temporibus cumque de<br /> <br /> <strong>Exclusion criteria comments</strong><br /> Occaecat officia qui<br /> <br /> <strong>The inclusion of vulnerable population is justifiable only if this information cannot be obtained from non‑vulnerable populations For incapacitated or minor participants, the trial should offer some direct benefit to the tem or to the population that they represent</strong><br /> Ab sunt ut voluptas<br /> <br /> <strong>Vulnerable populations comments</strong><br /> Illo cillum esse con<br /> <br /> <strong>Brief description of the study plan and design, and whenever possible, include a diagram/flow chart Discuss the expected duration of the participants' participation and a description of the sequence and duration of all the clinical trial periods, including the follow up</strong><br /> Doloremque assumenda<br /> <br /> <strong>Study plan and design comments</strong><br /> Ratione ut facere au<br /> <br /> <strong>Consider the dose(s)/dose steps, dose rationale, route of administration, schedule, treatment duration, and dose modifications</strong><br /> Sunt voluptatibus la<br /> <br /> <strong>Study treatment comments</strong><br /> Labore et eu ipsum c<br /> <br /> <strong>Comparator IMP(s) workspace</strong><br /> Nostrum explicabo R<br /> <br /> <strong>Comparator IMP(s) comments</strong><br /> Et itaque nisi omnis<br /> <br /> <strong>Placebo workspace</strong><br /> Quidem eum dignissim<br /> <br /> <strong>Placebo comments</strong><br /> Provident in ex nob<br /> <br /> <strong>Auxilliary medicinal product(s) workspace</strong><br /> Quibusdam culpa dolo<br /> <br /> <strong>Auxilliary medicinal product(s) comments</strong><br /> Deserunt ut reprehen<br /> <br /> <strong>Additional considerations workspace</strong><br /> Enim quaerat odit di<br /> <br /> <strong>Additional considerations comments</strong><br /> Accusamus esse at q<br /> <br /> <strong>Brief description of the important safety risks associated with trial treatments identified in any previous clinical trials, and as outlined in the IB or SmPC, or from another source</strong><br /> Aut itaque qui eum r<br /> <br /> <strong>Safety comments</strong><br /> Aut esse voluptatem<br /> <br /> <strong>Blinding and unblinding workspace</strong><br /> Dolore inventore dol<br /> <br /> <strong>Blinding and unblinding comments</strong><br /> Tempor voluptate ull<br /> <br /> <strong>Contraception measures workspace</strong><br /> Neque facere id rec<br /> <br /> <strong>Contraception measures comments</strong><br /> Hic cumque non repel<br /> <br /> <strong>Discontinuation criteria workspace</strong><br /> Sed eu ab eos sit e<br /> <br /> <strong>Discontinuation criteria comments</strong><br /> Quia reiciendis inci<br /> <br /> <strong>Other concomitant workspace</strong><br /> Qui aut vitae amet<br /> <br /> <strong>Other concomitant comments</strong><br /> Eos aliqua Eiusmod<br /> <br /> <strong>Safety and Monitoring workspace</strong><br /> Officiis qui praesen<br /> <br /> <strong>Safety and Monitoring comments</strong><br /> Culpa enim consectet<br /> <br /> <strong>Reference Safety Information workspace</strong><br /> Provident id offici<br /> <br /> <strong>Reference Safety Information comments</strong><br /> Laboriosam velit ve<br /> <br /> <strong>Data Safety Monitoring Committee workspace</strong><br /> Nulla reprehenderit<br /> <br /> <strong>Data Safety Monitoring Committee comments</strong><br /> Quo sint ut aute ab<br /> <br /> <strong>Definition of the end of the trial workspace</strong><br /> Illo ut dolor repreh<br /> <br /> <strong>Definition of the end of the trial comments</strong><br /> Ex aliquam dolor fug<br /> <br /> <strong>Biological samples used in the study workspace</strong><br /> Voluptatum suscipit<br /> <br /> <strong>Biological samples used in the study comments</strong><br /> Nisi labore incidunt<br /> <br /> <strong>Data protection workspace</strong><br /> Quae culpa sunt mag<br /> <br /> <strong>Data protection comments</strong><br /> Voluptatibus porro i<br /> <br /> <strong>Recruitment and informed consent procedures workspace</strong><br /> Quis quis ab veniam<br /> <br /> <strong>Recruitment and informed consent procedures comment</strong><br /> Iusto ducimus exerc<br /> <br /> <strong>Benefit/risk assessment workspace</strong><br /> Itaque veniam do re<br /> <br /> <strong>Comments on the benefit/risk:</strong><br /> Odio maxime repudian<br /> <br /> <strong>Assessor’s overall conclusions workspace</strong><br /> Reprehenderit et vol<br /> <br /> <strong>Overall comment/ conclusion on the clinical assessment:</strong><br /> Tenetur et sit nemo<br /> <br /> <strong>1.5.1 REQUESTS FOR ADDITIONAL INFORMATION</strong><br /> Cum suscipit explica<br />  </p>
      • recommendationHeading 1 Paragraph
      • notified0
      • accepted(null)
      • conflict(null)
      • statusSummary
      • created2025-02-28 14:20:32
      • modified2025-02-28 14:22:17
  • ActiveInspector(array)
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      • id15
      • user_id2
      • application_id127
      • typerequest
      • assessment_type(null)
      • titlePPB request
      • text
      • summary(null)
      • recommendation(null)
      • notified0
      • accepted(null)
      • conflict(null)
      • statusUnsubmitted
      • created2025-01-09 12:05:06
      • modified2025-01-09 12:05:06
    • 1(array)
      • id16
      • user_id33
      • application_id127
      • typerequest
      • assessment_type(null)
      • titlePPB request
      • textyou've been assigned this
      • summary(null)
      • recommendation(null)
      • notified0
      • accepted(null)
      • conflict(null)
      • statusUnsubmitted
      • created2025-01-13 11:27:26
      • modified2025-01-13 11:27:26
  • ManagerReview(array)
    • 0(array)
      • id15
      • user_id2
      • application_id127
      • typeppb_comment
      • assessment_type(null)
      • title(null)
      • text<p> manager comments</p>
      • summary(null)
      • recommendation<p> Managers recommendations</p>
      • notified0
      • accepted(null)
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      • created2025-01-07 08:51:31
      • modified2025-01-07 08:51:31
    • 1(array)
      • id19
      • user_id84
      • application_id127
      • typerequest
      • assessment_type(null)
      • titlePPB request
      • text
      • summary(null)
      • recommendationttest message
      • notified0
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      • created2025-01-07 10:17:34
      • modified2025-01-07 10:18:32
    • 2(array)
      • id21
      • user_id2
      • application_id127
      • typeppb_comment
      • assessment_type(null)
      • title(null)
      • text<p> The Role of Cybersecurity in Modern Organizations</p> <h4> Importance of Cybersecurity</h4> <p> In today's digital age, organizations rely heavily on technology to manage operations, store sensitive data, and connect with customers. This dependency on digital infrastructure has made cybersecurity a crucial aspect of business continuity, protecting against data breaches, cyberattacks, and other security threats.</p> <h4> Emerging Threats in Cyberspace</h4> <p> With the rapid evolution of cyber threats, including ransomware, phishing attacks, and advanced persistent threats, organizations face challenges in keeping their systems secure. These threats are becoming more sophisticated, targeting critical industries such as healthcare, finance, and government.</p> <h4> Strategies for Effective Cyber Defense</h4> <p> To mitigate these risks, companies must adopt robust security measures such as multi-factor authentication, endpoint detection, and encryption. Training employees on security best practices and conducting regular risk assessments are also essential in creating a proactive security culture.</p> <h4> Future of Cybersecurity</h4> <p> As the digital landscape continues to evolve, so must cybersecurity strategies. Innovations like artificial intelligence and machine learning are paving the way for more efficient threat detection and response systems. By staying ahead of trends, organizations can secure their assets and build trust with stakeholders.</p>
      • summary(null)
      • recommendation<p> The Role of Cybersecurity in Modern Organizations</p> <h4> Importance of Cybersecurity</h4> <p> In today's digital age, organizations rely heavily on technology to manage operations, store sensitive data, and connect with customers. This dependency on digital infrastructure has made cybersecurity a crucial aspect of business continuity, protecting against data breaches, cyberattacks, and other security threats.</p> <h4> Emerging Threats in Cyberspace</h4> <p> With the rapid evolution of cyber threats, including ransomware, phishing attacks, and advanced persistent threats, organizations face challenges in keeping their systems secure. These threats are becoming more sophisticated, targeting critical industries such as healthcare, finance, and government.</p> <h4> Strategies for Effective Cyber Defense</h4> <p> To mitigate these risks, companies must adopt robust security measures such as multi-factor authentication, endpoint detection, and encryption. Training employees on security best practices and conducting regular risk assessments are also essential in creating a proactive security culture.</p> <h4> Future of Cybersecurity</h4> <p> As the digital landscape continues to evolve, so must cybersecurity strategies. Innovations like artificial intelligence and machine learning are paving the way for more efficient threat detection and response systems. By staying ahead of trends, organizations can secure their assets and build trust with stakeholders.</p>
      • notified0
      • accepted(null)
      • conflict(null)
      • statusUnsubmitted
      • created2025-01-08 15:20:26
      • modified2025-01-08 15:20:26
    • 3(array)
      • id23
      • user_id2
      • application_id127
      • typeppb_comment
      • assessment_type(null)
      • title(null)
      • text<p> test password</p>
      • summary(null)
      • recommendation<p> test password</p>
      • notified0
      • accepted(null)
      • conflict(null)
      • statusUnsubmitted
      • created2025-01-09 12:56:28
      • modified2025-01-09 12:56:28
    • 4(array)
      • id24
      • user_id3
      • application_id127
      • typerequest
      • assessment_type(null)
      • titlePPB request
      • text
      • summary(null)
      • recommendation
      • notified0
      • acceptedaccepted
      • conflictNo
      • statusUnsubmitted
      • created2025-01-09 13:18:12
      • modified2025-01-09 13:19:04
    • 5(array)
      • id51
      • user_id83
      • application_id127
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      • assessment_type(null)
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      • summary<p> <strong>Trial category workspace</strong><br /> Rerum labore atque c<br /> <br /> <strong>Trial category comments</strong><br /> Aliquam nihil dolore<br /> <br /> <strong>Trial phase workspace</strong><br /> Ipsam nemo nulla sae<br /> <br /> <strong>Trial phase comments (if in disagreement with the study phase proposed): </strong><br /> Magni non tempore d<br /> <br /> <strong>Therapeutic condition workspace</strong><br /> Minus accusantium qu<br /> <br /> <strong>Brief description of the disease</strong><br /> Adipisci vero duis c<br /> <br /> <strong>Brief discussion of clinical pharmacokinetic data, efficacy and safety data described in the IB from previous trials /previously investigated indications(s) for the IMP(s). Non-clinical studies may also be discussed for early or FIH clinical trials. Consideration should be given to the justification provided based on the non-clinical data, for the proposed starting dose, dose steps, and maximum exposure</strong><br /> At fugiat laudantiu<br /> <br /> <strong>Assessor’s discussion on the clinical development:</strong><br /> Dicta dolore consequ<br /> <br /> <strong>Consider what is new in this trial, the clinical relevance, and the medical need that the trial aims to address</strong><br /> Odit minim doloremqu<br /> <br /> <strong>Clinical Trial Rationale comments</strong><br /> Veritatis suscipit d<br /> <br /> <strong>Consider if there are established primary endpoints for this type of study/indication, do they match the goals, are they validated?</strong><br /> Fugiat fugiat illo<br /> <br /> <strong>Primary objectives comments</strong><br /> Nobis laborum illo i<br /> <br /> <strong>Secondary objectives workspace</strong><br /> Nam sed officiis ver<br /> <br /> <strong>Secondary objectives comments</strong><br /> Minim ab nobis dolor<br /> <br /> <strong>Study population workspace</strong><br /> Voluptates vitae qua<br /> <br /> <strong>Study population comments</strong><br /> Velit impedit ea eu<br /> <br /> <strong>Take also into consideration the gender and age allocation of participants, and determine whether a specific group is excluded or underrepresented</strong><br /> Voluptatem Et quod<br /> <br /> <strong>Inclusion criteria comments</strong><br /> Quia quis suscipit v<br /> <br /> <strong>Check if a justification is provided in the event that a specific group is excluded or underrepresented Applicable for registered products, consider the contraindications included in the SmPC for the investigational medical product, comparator, and auxiliary medical products</strong><br /> Temporibus cumque de<br /> <br /> <strong>Exclusion criteria comments</strong><br /> Occaecat officia qui<br /> <br /> <strong>The inclusion of vulnerable population is justifiable only if this information cannot be obtained from non‑vulnerable populations For incapacitated or minor participants, the trial should offer some direct benefit to the tem or to the population that they represent</strong><br /> Ab sunt ut voluptas<br /> <br /> <strong>Vulnerable populations comments</strong><br /> Illo cillum esse con<br /> <br /> <strong>Brief description of the study plan and design, and whenever possible, include a diagram/flow chart Discuss the expected duration of the participants' participation and a description of the sequence and duration of all the clinical trial periods, including the follow up</strong><br /> Doloremque assumenda<br /> <br /> <strong>Study plan and design comments</strong><br /> Ratione ut facere au<br /> <br /> <strong>Consider the dose(s)/dose steps, dose rationale, route of administration, schedule, treatment duration, and dose modifications</strong><br /> Sunt voluptatibus la<br /> <br /> <strong>Study treatment comments</strong><br /> Labore et eu ipsum c<br /> <br /> <strong>Comparator IMP(s) workspace</strong><br /> Nostrum explicabo R<br /> <br /> <strong>Comparator IMP(s) comments</strong><br /> Et itaque nisi omnis<br /> <br /> <strong>Placebo workspace</strong><br /> Quidem eum dignissim<br /> <br /> <strong>Placebo comments</strong><br /> Provident in ex nob<br /> <br /> <strong>Auxilliary medicinal product(s) workspace</strong><br /> Quibusdam culpa dolo<br /> <br /> <strong>Auxilliary medicinal product(s) comments</strong><br /> Deserunt ut reprehen<br /> <br /> <strong>Additional considerations workspace</strong><br /> Enim quaerat odit di<br /> <br /> <strong>Additional considerations comments</strong><br /> Accusamus esse at q<br /> <br /> <strong>Brief description of the important safety risks associated with trial treatments identified in any previous clinical trials, and as outlined in the IB or SmPC, or from another source</strong><br /> Aut itaque qui eum r<br /> <br /> <strong>Safety comments</strong><br /> Aut esse voluptatem<br /> <br /> <strong>Blinding and unblinding workspace</strong><br /> Dolore inventore dol<br /> <br /> <strong>Blinding and unblinding comments</strong><br /> Tempor voluptate ull<br /> <br /> <strong>Contraception measures workspace</strong><br /> Neque facere id rec<br /> <br /> <strong>Contraception measures comments</strong><br /> Hic cumque non repel<br /> <br /> <strong>Discontinuation criteria workspace</strong><br /> Sed eu ab eos sit e<br /> <br /> <strong>Discontinuation criteria comments</strong><br /> Quia reiciendis inci<br /> <br /> <strong>Other concomitant workspace</strong><br /> Qui aut vitae amet<br /> <br /> <strong>Other concomitant comments</strong><br /> Eos aliqua Eiusmod<br /> <br /> <strong>Safety and Monitoring workspace</strong><br /> Officiis qui praesen<br /> <br /> <strong>Safety and Monitoring comments</strong><br /> Culpa enim consectet<br /> <br /> <strong>Reference Safety Information workspace</strong><br /> Provident id offici<br /> <br /> <strong>Reference Safety Information comments</strong><br /> Laboriosam velit ve<br /> <br /> <strong>Data Safety Monitoring Committee workspace</strong><br /> Nulla reprehenderit<br /> <br /> <strong>Data Safety Monitoring Committee comments</strong><br /> Quo sint ut aute ab<br /> <br /> <strong>Definition of the end of the trial workspace</strong><br /> Illo ut dolor repreh<br /> <br /> <strong>Definition of the end of the trial comments</strong><br /> Ex aliquam dolor fug<br /> <br /> <strong>Biological samples used in the study workspace</strong><br /> Voluptatum suscipit<br /> <br /> <strong>Biological samples used in the study comments</strong><br /> Nisi labore incidunt<br /> <br /> <strong>Data protection workspace</strong><br /> Quae culpa sunt mag<br /> <br /> <strong>Data protection comments</strong><br /> Voluptatibus porro i<br /> <br /> <strong>Recruitment and informed consent procedures workspace</strong><br /> Quis quis ab veniam<br /> <br /> <strong>Recruitment and informed consent procedures comment</strong><br /> Iusto ducimus exerc<br /> <br /> <strong>Benefit/risk assessment workspace</strong><br /> Itaque veniam do re<br /> <br /> <strong>Comments on the benefit/risk:</strong><br /> Odio maxime repudian<br /> <br /> <strong>Assessor’s overall conclusions workspace</strong><br /> Reprehenderit et vol<br /> <br /> <strong>Overall comment/ conclusion on the clinical assessment:</strong><br /> Tenetur et sit nemo<br /> <br /> <strong>1.5.1 REQUESTS FOR ADDITIONAL INFORMATION</strong><br /> Cum suscipit explica<br />  </p>
      • recommendationHeading 1 Paragraph
      • notified0
      • accepted(null)
      • conflict(null)
      • statusSummary
      • created2025-02-28 14:20:32
      • modified2025-02-28 14:22:17
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      • trial_administration_humans(null)
      • trial_bioequivalence_study(null)
      • trial_other(null)
      • trial_other_specify(null)
      • trial_therapeutic_exploratory(null)
      • trial_therapeutic_confirmatory(null)
      • trial_therapeutic_use(null)
      • design_controlled
      • site_capacity(null)
      • staff_numbers
      • other_details_explanation
      • other_details_regulatory_notapproved
      • other_details_regulatory_approved
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_duration
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_state
      • location_of_area
      • multiple_sites_member_state
      • multiple_countries
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committee
      • total_enrolment_per_site
      • total_participants_worldwide
      • population_less_than_18_years
      • population_utero
      • population_preterm_newborn
      • population_newborn
      • population_infant_and_toddler
      • population_children
      • population_adolescent
      • population_above_18
      • population_adult
      • population_elderly
      • gender_female(null)
      • gender_male(null)
      • subjects_healthy
      • subjects_patients
      • subjects_vulnerable_populations
      • subjects_women_child_bearing
      • subjects_women_using_contraception
      • subjects_pregnant_women
      • subjects_nursing_women
      • subjects_emergency_situation
      • subjects_incapable_consent
      • subjects_specify
      • subjects_others
      • subjects_others_specify
      • investigator1_given_name(null)
      • investigator1_middle_name(null)
      • investigator1_family_name(null)
      • investigator1_qualification(null)
      • investigator1_professional_address(null)
      • organisations_transferred_(null)
      • number_participants
      • notification
      • approval_date(null)
      • submitted1
      • date_submitted2025-02-13 17:12:07
      • modified2025-02-13 17:12:07
      • created2025-02-13 17:11:27
    • 4(array)
      • id39
      • application_id127
      • trial_status_id(null)
      • abstract_of_study<p> Latest ammendment field</p>
      • study_title<p> latest ammenment</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_submitted2025-02-14 12:21:43
      • modified2025-02-14 12:21:43
      • created2025-02-14 12:20:59
    • 5(array)
      • id40
      • application_id127
      • trial_status_id(null)
      • abstract_of_study<p> Ammendment n field</p>
      • study_title<p> Ammendment n</p>
      • laymans_summary
      • protocol_no(null)
      • version_no3.1
      • date_of_protocol(null)
      • study_drug
      • disease_condition
      • product_type(null)
      • product_type_biologicals(null)
      • product_type_proteins(null)
      • product_type_immunologicals(null)
      • product_type_vaccines(null)
      • product_type_hormones(null)
      • product_type_toxoid(null)
      • product_type_chemical(null)
      • product_type_medical_device(null)
      • product_type_chemical_name(null)
      • product_type_medical_device_name(null)
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • previous_dates(null)
      • coordinating_investigators
      • principal_investigators
      • pharmacist
      • sponsor_details
      • gender
      • details_of_sites
      • placebos
      • scopes
      • organizations
      • types_and_phases
      • ecct_not_applicable0
      • ecct_ref_number
      • email_address(null)
      • applicant_covering_letter(null)
      • applicant_protocol(null)
      • applicant_patient_information(null)
      • applicant_investigators_brochure(null)
      • applicant_investigators_cv(null)
      • applicant_signed_declaration(null)
      • applicant_financial_declaration(null)
      • applicant_gmp_certificate(null)
      • applicant_indemnity_cover(null)
      • applicant_opinion_letter(null)
      • applicant_approval_letter(null)
      • applicant_statement(null)
      • applicant_participating_countries(null)
      • applicant_addendum(null)
      • applicant_fees(null)
      • declaration_applicant
      • declaration_date1(null)
      • declaration_principal_investigator
      • declaration_date2(null)
      • placebo_present
      • study_objectives
      • principal_inclusion_criteria
      • principal_exclusion_criteria
      • primary_end_points
      • scope_diagnosis(null)
      • scope_prophylaxis(null)
      • scope_therapy(null)
      • scope_safety(null)
      • scope_efficacy(null)
      • scope_pharmacokinetic(null)
      • scope_pharmacodynamic(null)
      • scope_bioequivalence(null)
      • scope_dose_response(null)
      • scope_pharmacogenetic(null)
      • scope_pharmacogenomic(null)
      • scope_pharmacoecomomic(null)
      • scope_others(null)
      • scope_others_specify(null)
      • trial_human_pharmacology(null)
      • trial_administration_humans(null)
      • trial_bioequivalence_study(null)
      • trial_other(null)
      • trial_other_specify(null)
      • trial_therapeutic_exploratory(null)
      • trial_therapeutic_confirmatory(null)
      • trial_therapeutic_use(null)
      • design_controlled
      • site_capacity(null)
      • staff_numbers
      • other_details_explanation
      • other_details_regulatory_notapproved
      • other_details_regulatory_approved
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_duration
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_state
      • location_of_area
      • multiple_sites_member_state
      • multiple_countries
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committee
      • total_enrolment_per_site
      • total_participants_worldwide
      • population_less_than_18_years
      • population_utero
      • population_preterm_newborn
      • population_newborn
      • population_infant_and_toddler
      • population_children
      • population_adolescent
      • population_above_18
      • population_adult
      • population_elderly
      • gender_female(null)
      • gender_male(null)
      • subjects_healthy
      • subjects_patients
      • subjects_vulnerable_populations
      • subjects_women_child_bearing
      • subjects_women_using_contraception
      • subjects_pregnant_women
      • subjects_nursing_women
      • subjects_emergency_situation
      • subjects_incapable_consent
      • subjects_specify
      • subjects_others
      • subjects_others_specify
      • investigator1_given_name(null)
      • investigator1_middle_name(null)
      • investigator1_family_name(null)
      • investigator1_qualification(null)
      • investigator1_professional_address(null)
      • organisations_transferred_(null)
      • number_participants
      • notification
      • approval_date(null)
      • submitted1
      • date_submitted2025-02-17 08:50:57
      • modified2025-02-17 08:50:57
      • created2025-02-17 08:50:02
    • 6(array)
      • id41
      • application_id127
      • trial_status_id(null)
      • abstract_of_study
      • study_title<p> test ammendment</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_investigatorstest
      • principal_investigatorstest2
      • pharmacisttest3
      • 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)
      • submitted0
      • date_submitted(null)
      • modified2025-02-18 08:58:59
      • created2025-02-18 08:53:29
  • InvestigatorContact(array)
    • 0(array)
      • id84
      • application_id127
      • given_nameAidan Madden
      • middle_nameYeo Christensen
      • family_nameNola Nielsen
      • qualificationNecessitatibus sed amet quia mollitia quia magnam nostrum elit vel et repellendus Culpa
      • professional_addressConsectetur iure ea blanditiis illo facilis sed magna elit non alias
      • telephone+1 (375) 498-2766
      • emailtomap@mailinator.com
      • created2025-01-06 15:08:18
      • modified2025-02-06 14:33:08
  • ApplicationStage(array)
    • 0(array)
      • id239
      • application_id127
      • stageScreening
      • start_date2025-01-07
      • statusComplete
      • commentManager final decision
      • end_date2025-01-07
      • created2025-01-07 08:17:29
      • modified2025-01-07 08:17:29
    • 1(array)
      • id240
      • application_id127
      • stageScreeningSubmission
      • start_date2025-01-07
      • statusComplete
      • commentManager final decision
      • end_date2025-01-07
      • created2025-01-07 08:50:52
      • modified2025-01-07 08:50:52
    • 2(array)
      • id241
      • application_id127
      • stageAssign
      • start_date2025-01-07
      • statusComplete
      • commentManager final decision
      • end_date2025-01-07
      • created2025-01-07 08:50:52
      • modified2025-01-07 08:50:52
    • 3(array)
      • id242
      • application_id127
      • stageReview
      • start_date2025-01-07
      • statusComplete
      • commentManager final decision
      • end_date2025-01-07
      • created2025-01-07 08:50:52
      • modified2025-01-07 08:50:52
    • 4(array)
      • id243
      • application_id127
      • stageReviewSubmission
      • start_date2025-01-07
      • statusCurrent
      • commentManager new comment
      • end_date(null)
      • created2025-01-07 08:50:52
      • modified2025-01-07 08:50:52
    • 5(array)
      • id244
      • application_id127
      • stageFinalDecision
      • start_date2025-01-07
      • statusComplete
      • commentManager final decision
      • end_date2025-01-07
      • created2025-01-07 08:50:52
      • modified2025-01-07 08:50:52
    • 6(array)
      • id245
      • application_id127
      • stageAnnualApproval
      • start_date2025-01-07
      • statusCurrent
      • commentManager letter approve
      • end_date2026-01-07
      • created2025-01-07 08:50:52
      • modified2025-01-07 08:50:52
    • 7(array)
      • id253
      • application_id127
      • stageUnsubmitted
      • start_date2025-01-09
      • statusComplete
      • commentPrincipal Investigator Re Submission
      • end_date2025-01-09
      • created2025-01-09 12:35:38
      • modified2025-01-09 12:35:38
  • Pharmacist(array)
    • 0(array)
      • id34
      • application_id127
      • reg_no527
      • given_nameXaviera Horton
      • premise_nameGarrett Erickson
      • qualificationExcepturi ut cumque voluptates blanditiis voluptatem exercitation
      • professional_addressCorrupti ut qui optio numquam facere possimus aut quos
      • valid_year1978
      • mobile773
      • telephone+1 (943) 348-1948
      • emailhagoqoqyma@mailinator.com
      • created2025-01-06 15:08:18
      • modified2025-02-06 14:33:08
  • EthicalCommittee(array)
    • 0(array)
      • id35
      • application_id127
      • ethical_committeeAfrica International University
      • submission_date18-10-2016
      • erc_number752
      • initial_approval06-04-1977
      • created2025-01-06 15:08:18
      • modified2025-02-06 14:33:08
  • AnnualLetter(array)
    • 0(array)
      • id23
      • application_id127
      • approval_noECCT/25/01/01/2025(10)
      • 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/25/01/01/2025(10)                                                                                                                                                                             7th January 2025</strong></span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><strong>Aidan Madden Yeo Christensen Nola Nielsen,</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/25/01/01,</strong></span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><strong>Consectetur iure ea blanditiis illo facilis sed magna elit non alias,</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/25/01/01 : Initial Approval; <p> Laborum Doloribus illo impedi</p>   Laborum Doloribus illo impedi</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/1158">art_monthly_report_2025_01_06_08_56_08.xls</a> dated 6th January 2025 Version <br>2. Financial declaration by Sponsor and/or PI<br><a href="http://45.79.161.190:8080/attachments/download/1159">approvalletter_14</a> dated 6th January 2025 Version <br>3. The Study Protocol<br><a href="http://45.79.161.190:8080/attachments/download/1160">approvalletter_14</a> dated 7th January 2025 Version <br>4. Registration of the study at Pan African Clinical Trials Registry https://pactr.samrc.ac.za<br><a href="http://45.79.161.190:8080/attachments/download/1161">approvalletter_14</a> dated 7th January 2025 Version <br>5. Patient Information leaflet and Informed consent form<br><a href="http://45.79.161.190:8080/attachments/download/1162">approvalletter_14</a> dated 7th January 2025 Version 1<br>6. Investigators Brochure/Package inserts<br><a href="http://45.79.161.190:8080/attachments/download/1163">approvalletter_14</a> dated 7th January 2025 Version <br>7. Investigational Medicinal Product Dossier (IMPD)<br><a href="http://45.79.161.190:8080/attachments/download/1164">approvalletter_14</a> dated 7th January 2025 Version 2.1<br>8. GMP certificate of the investigational product from the site of manufacture<br><a href="http://45.79.161.190:8080/attachments/download/1165">approvalletter_14</a> dated 7th January 2025 Version <br>9. Evidence of recent GCP training of the core study staff<br><a href="http://45.79.161.190:8080/attachments/download/1166">approvalletter_14</a> dated 7th January 2025 Version 2<br>10. Adequate data and information from previous studies and Phases to support carrying out of the current study<br><a href="http://45.79.161.190:8080/attachments/download/1167">approvalletter_14</a> dated 7th January 2025 Version <br>11. Stability data of the investigational product<br><a href="http://45.79.161.190:8080/attachments/download/1168">approvalletter_14</a> dated 7th January 2025 Version <br>12. Certificate of Analysis of the investigational product<br><a href="http://45.79.161.190:8080/attachments/download/1169">approvalletter_14</a> dated 7th January 2025 Version <br>13. Pictorial Sample of the investigational products. This sample should include the text of the labeling to be used<br><a href="http://45.79.161.190:8080/attachments/download/1170">approvalletter_14</a> dated 1st January 1970 Version <br>14. 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/1171">approvalletter_14</a> dated 7th January 2025 Version <br>15. DSMB Charter including the composition and meeting schedule<br><a href="http://45.79.161.190:8080/attachments/download/1172">approvalletter_14</a> dated 7th January 2025 Version <br>16. Detailed budget of the study<br><a href="http://45.79.161.190:8080/attachments/download/1173">approvalletter_14</a> dated 1st January 1970 Version <br>17. Indemnity cover for PI, investigators and study Pharmacist. <br><a href="http://45.79.161.190:8080/attachments/download/1174">approvalletter_14</a> dated 7th January 2025 Version <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="http://45.79.161.190:8080/attachments/download/1175">approvalletter_14</a> dated 7th January 2025 Version <br>19. Clinical Trials Insurance cover for study participants<br><a href="http://45.79.161.190:8080/attachments/download/1176">approvalletter_14</a> dated 7th January 2025 Version <br>20. Copy of favorable opinion letter from the local Ethics Review Committee (ERC).<br><a href="http://45.79.161.190:8080/attachments/download/1177">approvalletter_14</a> dated 7th January 2025 Version <br>21. Copy of current Practice Licenses for the Investigators and study Pharmacist<br><a href="http://45.79.161.190:8080/attachments/download/1178">approvalletter_14</a> dated 7th January 2025 Version 3<br>22. Copy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable<br><a href="http://45.79.161.190:8080/attachments/download/1179">approvalletter_14</a> dated 7th January 2025 Version <br>23. For multicentre/multi-site studies, a site specific addendum for each of the proposed sites including among other things the sites’ capacity to carry out the study i.e personnel, equipment, laboratory etc<br><a href="http://45.79.161.190:8080/attachments/download/1180">approvalletter_14</a> dated 7th January 2025 Version <br>24. 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/1181">approvalletter_14</a> dated 7th January 2025 Version <br>25. Payment of fees<br><a href="http://45.79.161.190:8080/attachments/download/1182">approvalletter_14</a> dated 7th January 2025 Version <br>26. Statistical Analysis Plan<br><a href="http://45.79.161.190:8080/attachments/download/1183">approvalletter_14</a> dated 7th January 2025 Version <br>27. Signed Checklist<br><a href="http://45.79.161.190:8080/attachments/download/1184">approvalletter_14</a> dated 7th January 2025 Version <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: <p> Laborum Doloribus illo impedi</p> ECCT/25/01/01<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>7th January 2026</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>
      • qrcode(null)
      • approvermanager
      • approval_date07-01-2025
      • expiry_date07-01-2026
      • statussubmitted
      • deleted0
      • deleted_date(null)
      • created2025-01-07 08:50:52
      • modified2025-01-07 08:50:52
    • 1(array)
      • id47
      • application_id127
      • approval_noECCT/2/2025-ECCT/25/01/01
      • 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/2/2025-ECCT/25/01/01                                                                                                                                                                             8 Jan 2025</strong></span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><strong>Aidan Madden Yeo Christensen Nola Nielsen,</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/25/01/01,</strong></span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><strong>Consectetur iure ea blanditiis illo facilis sed magna elit non alias,</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/25/01/01 : Initial Approval; <p> Laborum Doloribus illo impedi</p>   Laborum Doloribus illo impedi</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="/attachments/download/1158">art_monthly_report_2025_01_06_08_56_08.xls</a> dated 6th January 2025 Version <br>2. The Study Protocol<br><a href="/attachments/download/1160">approvalletter_14</a> dated 7th January 2025 Version <br>3. Registration of the study at Pan African Clinical Trials Registry https://pactr.samrc.ac.za<br><a href="/attachments/download/1161">approvalletter_14</a> dated 7th January 2025 Version <br>4. Patient Information leaflet and Informed consent form<br><a href="/attachments/download/1162">approvalletter_14</a> dated 7th January 2025 Version 1<br>5. Investigators Brochure/Package inserts<br><a href="/attachments/download/1163">approvalletter_14</a> dated 7th January 2025 Version <br>6. Investigational Medicinal Product Dossier (IMPD)<br><a href="/attachments/download/1164">approvalletter_14</a> dated 7th January 2025 Version 2.1<br>7. Adequate data and information from previous studies and Phases to support carrying out of the current study<br><a href="/attachments/download/1167">approvalletter_14</a> dated 7th January 2025 Version <br>8. Stability data of the investigational product<br><a href="/attachments/download/1168">approvalletter_14</a> dated 7th January 2025 Version <br>9. GMP certificate of the investigational product from the site of manufacture<br><a href="/attachments/download/1165">approvalletter_14</a> dated 7th January 2025 Version <br>10. Certificate of Analysis of the investigational product<br><a href="/attachments/download/1169">approvalletter_14</a> dated 7th January 2025 Version <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/1170">approvalletter_14</a> dated Version <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/1171">approvalletter_14</a> dated 7th January 2025 Version <br>13. Evidence of recent GCP training of the core study staff<br><a href="/attachments/download/1166">approvalletter_14</a> dated 7th January 2025 Version 2<br>14. DSMB Charter including the composition and meeting schedule<br><a href="/attachments/download/1172">approvalletter_14</a> dated 7th January 2025 Version <br>15. Detailed budget of the study<br><a href="/attachments/download/1173">approvalletter_14</a> dated Version <br>16. Financial declaration by Sponsor and/or PI<br><a href="/attachments/download/1159">approvalletter_14</a> dated 6th January 2025 Version <br>17. Signed Declaration by Sponsor or Principal investigator that the study will be carried out according to the protocol and applicable laws, regulations and GCP requirements.<br><a href="/attachments/download/1175">approvalletter_14</a> dated 7th January 2025 Version <br>18. Indemnity cover for PI, investigators and study Pharmacist. <br><a href="/attachments/download/1174">approvalletter_14</a> dated 7th January 2025 Version <br>19. Clinical Trials Insurance cover for study participants<br><a href="/attachments/download/1176">approvalletter_14</a> dated 7th January 2025 Version <br>20. Copy of favorable opinion letter from the local Ethics Review Committee (ERC).<br><a href="/attachments/download/1177">approvalletter_14</a> dated 7th January 2025 Version <br>21. Copy of current Practice Licenses for the Investigators and study Pharmacist<br><a href="/attachments/download/1178">approvalletter_14</a> dated 7th January 2025 Version 3<br>22. Copy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable<br><a href="/attachments/download/1179">approvalletter_14</a> dated 7th January 2025 Version <br>23. For multicentre/multi-site studies, a site specific addendum for each of the proposed sites including among other things the sites’ capacity to carry out the study i.e personnel, equipment, laboratory etc<br><a href="/attachments/download/1180">approvalletter_14</a> dated 7th January 2025 Version <br>24. 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/1181">approvalletter_14</a> dated 7th January 2025 Version <br>25. Payment of fees<br><a href="/attachments/download/1182">approvalletter_14</a> dated 7th January 2025 Version <br>26. Statistical Analysis Plan<br><a href="/attachments/download/1183">approvalletter_14</a> dated 7th January 2025 Version <br>27. Signed Checklist<br><a href="/attachments/download/1184">approvalletter_14</a> dated 7th January 2025 Version <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>        </strong></span></p> <p> <span style="font-size:12px;">The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study: <p> Laborum Doloribus illo impedi</p> ECCT/25/01/01<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>7th January 2026</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_date08-01-2025
      • expiry_date08-01-2026
      • statussubmitted
      • deleted0
      • deleted_date(null)
      • created2025-01-08 15:31:02
      • modified2025-01-08 15:31:02
    • 2(array)
      • id48
      • application_id127
      • approval_noECCT/3/2025-ECCT/25/01/01
      • 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/3/2025-ECCT/25/01/01                                                                                                                                                                             9 Jan 2025</strong></span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><strong>Aidan Madden Yeo Christensen Nola Nielsen,</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/25/01/01,</strong></span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><strong>Consectetur iure ea blanditiis illo facilis sed magna elit non alias,</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/25/01/01 : Initial Approval; <p> Laborum Doloribus illo impedi</p>   Laborum Doloribus illo impedi</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="/attachments/download/1158">art_monthly_report_2025_01_06_08_56_08.xls</a> dated 6th January 2025 Version <br>2. The Study Protocol<br><a href="/attachments/download/1160">approvalletter_14</a> dated 7th January 2025 Version <br>3. Registration of the study at Pan African Clinical Trials Registry https://pactr.samrc.ac.za<br><a href="/attachments/download/1161">approvalletter_14</a> dated 7th January 2025 Version <br>4. Patient Information leaflet and Informed consent form<br><a href="/attachments/download/1162">approvalletter_14</a> dated 7th January 2025 Version 1<br>5. Investigators Brochure/Package inserts<br><a href="/attachments/download/1163">approvalletter_14</a> dated 7th January 2025 Version <br>6. Investigational Medicinal Product Dossier (IMPD)<br><a href="/attachments/download/1164">approvalletter_14</a> dated 7th January 2025 Version 2.1<br>7. Adequate data and information from previous studies and Phases to support carrying out of the current study<br><a href="/attachments/download/1167">approvalletter_14</a> dated 7th January 2025 Version <br>8. Stability data of the investigational product<br><a href="/attachments/download/1168">approvalletter_14</a> dated 7th January 2025 Version <br>9. GMP certificate of the investigational product from the site of manufacture<br><a href="/attachments/download/1165">approvalletter_14</a> dated 7th January 2025 Version <br>10. Certificate of Analysis of the investigational product<br><a href="/attachments/download/1169">approvalletter_14</a> dated 7th January 2025 Version <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/1170">approvalletter_14</a> dated Version <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/1171">approvalletter_14</a> dated 7th January 2025 Version <br>13. Evidence of recent GCP training of the core study staff<br><a href="/attachments/download/1166">approvalletter_14</a> dated 7th January 2025 Version 2<br>14. DSMB Charter including the composition and meeting schedule<br><a href="/attachments/download/1172">approvalletter_14</a> dated 7th January 2025 Version <br>15. Detailed budget of the study<br><a href="/attachments/download/1173">approvalletter_14</a> dated Version <br>16. Financial declaration by Sponsor and/or PI<br><a href="/attachments/download/1159">approvalletter_14</a> dated 6th January 2025 Version <br>17. Signed Declaration by Sponsor or Principal investigator that the study will be carried out according to the protocol and applicable laws, regulations and GCP requirements.<br><a href="/attachments/download/1175">approvalletter_14</a> dated 7th January 2025 Version <br>18. Indemnity cover for PI, investigators and study Pharmacist. <br><a href="/attachments/download/1174">approvalletter_14</a> dated 7th January 2025 Version <br>19. Clinical Trials Insurance cover for study participants<br><a href="/attachments/download/1176">approvalletter_14</a> dated 7th January 2025 Version <br>20. Copy of favorable opinion letter from the local Ethics Review Committee (ERC).<br><a href="/attachments/download/1177">approvalletter_14</a> dated 7th January 2025 Version <br>21. Copy of current Practice Licenses for the Investigators and study Pharmacist<br><a href="/attachments/download/1178">approvalletter_14</a> dated 7th January 2025 Version 3<br>22. Copy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable<br><a href="/attachments/download/1179">approvalletter_14</a> dated 7th January 2025 Version <br>23. For multicentre/multi-site studies, a site specific addendum for each of the proposed sites including among other things the sites’ capacity to carry out the study i.e personnel, equipment, laboratory etc<br><a href="/attachments/download/1180">approvalletter_14</a> dated 7th January 2025 Version <br>24. 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/1181">approvalletter_14</a> dated 7th January 2025 Version <br>25. Payment of fees<br><a href="/attachments/download/1182">approvalletter_14</a> dated 7th January 2025 Version <br>26. Statistical Analysis Plan<br><a href="/attachments/download/1183">approvalletter_14</a> dated 7th January 2025 Version <br>27. Signed Checklist<br><a href="/attachments/download/1184">approvalletter_14</a> dated 7th January 2025 Version <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>        </strong></span></p> <p> <span style="font-size:12px;">The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study: <p> Laborum Doloribus illo impedi</p> ECCT/25/01/01<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>7th January 2026</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_date09-01-2025
      • expiry_date09-01-2026
      • statussubmitted
      • deleted0
      • deleted_date(null)
      • created2025-01-09 12:16:00
      • modified2025-01-09 12:16:00
    • 3(array)
      • id49
      • application_id127
      • approval_noECCT/4/2025-ECCT/25/01/01
      • 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/4/2025-ECCT/25/01/01                                                                                                                                                                             9 Jan 2025</strong></span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><strong>Aidan Madden Yeo Christensen Nola Nielsen,</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/25/01/01,</strong></span></span></p> <p> <span style="font-size:12px;"><span style="font-family:bookman old style,serif;"><strong>Consectetur iure ea blanditiis illo facilis sed magna elit non alias,</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/25/01/01 : Annual Approval; <p> Laborum Doloribus illo impedi</p>   Laborum Doloribus illo impedi</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;"></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: <p> Laborum Doloribus illo impedi</p> ECCT/25/01/01<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>9th January 2026</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_date09-01-2025
      • expiry_date09-01-2026
      • statussubmitted
      • deleted0
      • deleted_date(null)
      • created2025-01-09 12:16:20
      • modified2025-01-09 12:16:20
  • AmendmentLetter(array)
    • 0(array)
      • id14
      • application_id127
      • approval_noPPB/ECCT/25/01/01/2025(5)
      • content<h3 style="text-align: center;"> <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></h3> <p style="text-align: center;"> <span style="font-family:bookman old style,serif;"><strong>MINISTRY</strong> <strong>OF</strong> <strong>HEALTH</strong></span></p> <p style="text-align: center;"> <span style="font-family:bookman old style,serif;"><strong>PHARMACY</strong> <strong>AND</strong> <strong>POISONS</strong> <strong>BOARD</strong></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-family:bookman old style,serif;"><span style="font-size:12px;">Telegram: "MINHEALTH", Nairobi</span></span></p> <p> <span style="font-family:bookman old style,serif;"><span style="font-size:12px;">Cell phone: 0709 770 100</span></span></p> <p> <span style="font-family:bookman old style,serif;"><span style="font-size:12px;">Email: info@pharmacyboardkenya.org</span></span></p> <p> <span style="font-family:bookman old style,serif;"><span style="font-size:12px;">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-family:bookman old style,serif;">Pharmacy and Poisons Board House</span></p> <p> <span style="font-family:bookman old style,serif;">Along Lenana Road </span></p> <p> <span style="font-family:bookman old style,serif;">P.O. Box 27663-00506 </span></p> <p> <span style="font-family:bookman old style,serif;">NAIROBI </span></p> <p> <span style="font-family:bookman old style,serif;"><strong>17th February 2025 </strong></span></p> </div> </td> </tr> </tbody> </table> <p> <span style="font-family:bookman old style,serif;">Dear Sir/Madam,</span></p> <p> <span style="font-family:bookman old style,serif;"><strong><u>Re: ECCT/25/01/01 : Amendment Approval; <p> Laborum Doloribus illo impedi</p> .</u></strong></span></p> <p> <span style="font-family:bookman old style,serif;">Reference is made to the above study.</span></p> <p> <span style="font-family:bookman old style,serif;">We acknowledge receipt of the following documents;</span></p> <div style="margin-left: 15px;"> <span style="font-family:bookman old style,serif;">1. Cover letter <br><a href="http://45.79.161.190:8080/attachments/download/1656">screenshot_from_2025_02_14_12_06_10.png</a> dated Version <br><a href="http://45.79.161.190:8080/attachments/download/1662">screenshot_from_2025_02_14_12_06_10_7.png</a> dated Version <br>2. Summary of the proposed amendment.<br><a href="http://45.79.161.190:8080/attachments/download/1657">screenshot_from_2025_02_14_12_06_10_2.png</a> dated Version <br>3. Reason for the amendment.<br><a href="http://45.79.161.190:8080/attachments/download/1658">screenshot_from_2025_02_14_12_06_10_3.png</a> dated Version <br>4. Impact of the amendment on the original study objectives.<br><a href="http://45.79.161.190:8080/attachments/download/1659">screenshot_from_2025_02_14_12_06_10_4.png</a> dated Version <br>5. Impact of the amendment on the data generated<br><a href="http://45.79.161.190:8080/attachments/download/1660">screenshot_from_2025_02_14_12_06_10_5.png</a> dated Version <br>6. Impact of the amendment on safety and well-being.<br><a href="http://45.79.161.190:8080/attachments/download/1661">screenshot_from_2025_02_14_12_06_10_6.png</a> dated Version <br></span></div> <p> <span style="font-family:bookman old style,serif;">After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials grants amendment approval to the study <strong><p> Laborum Doloribus illo impedi</p> </strong><strong>.</strong> <strong>(ECCT/25/01/01).</strong></span></p> <p>  </p> <p> <span style="font-family:bookman old style,serif;">Yours Sincerely,</span></p> <p> <span style="font-family:bookman old style,serif;">:signature</span></p> <p> <span style="font-family:bookman old style,serif;">:approver</span></p> <p> <span style="font-family:bookman old style,serif;"><strong><u>For Chief Executive Officer</u></strong></span></p> <p>  </p>
      • 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      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2025_02_13_08_50_30_2.png
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      • dirnameimg
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      • checksum47a8ae9bdeed1883ea31e1a9c00373e6
      • alternative(null)
      • groupsae_susar_log
      • descriptionSAE and SUSAR cumulative logs
      • year2025
      • file_date13-02-2025
      • pocket_namesae_susar_log
      • version_no2
      • created2025-02-13 09:03:47
      • modified2025-02-13 09:03:47
      • pathimg/screenshot_from_2025_02_13_08_50_30_2.png
    • 3(array)
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      • dirnameimg
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      • checksum6bc16b9365978e78648a538ca8d5f737
      • alternative(null)
      • groupdsmb
      • descriptionLatest Data Safety Monitoring Board (DSMB) report
      • year2025
      • file_date13-02-2025
      • pocket_namedsmb
      • version_no3
      • created2025-02-13 09:04:03
      • modified2025-02-13 09:04:03
      • pathimg/screenshot_from_2025_02_12_15_02_21.png
    • 4(array)
      • id1606
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      • dirnameimg
      • basenamescreenshot_from_2025_02_12_15_02_21_2.png
      • checksum6bc16b9365978e78648a538ca8d5f737
      • alternative(null)
      • groupprotocol_violations
      • descriptionProtocol Violations and Protocol Deviations logs
      • year2025
      • file_date13-02-2025
      • pocket_nameprotocol_violations
      • version_no1
      • created2025-02-13 09:04:23
      • modified2025-02-13 09:04:23
      • pathimg/screenshot_from_2025_02_12_15_02_21_2.png
    • 5(array)
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      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2025_02_12_15_02_21_3.png
      • foreign_key127
      • dirnameimg
      • basenamescreenshot_from_2025_02_12_15_02_21_3.png
      • checksum6bc16b9365978e78648a538ca8d5f737
      • alternative(null)
      • groupimpd
      • descriptionUpdated Investigators Brochure/Package inserts or Investigational Medicinal Product Dossier (IMPD)
      • year2025
      • file_date13-02-2025
      • pocket_nameimpd
      • version_no2
      • created2025-02-13 09:04:36
      • modified2025-02-13 09:04:36
      • pathimg/screenshot_from_2025_02_12_15_02_21_3.png
    • 6(array)
      • id1611
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      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2025_02_12_15_02_21_4.png
      • foreign_key127
      • dirnameimg
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      • checksum6bc16b9365978e78648a538ca8d5f737
      • alternative(null)
      • groupprogress_report
      • descriptionAnnual progress report
      • year2025
      • file_date13-02-2025
      • pocket_nameprogress_report
      • version_no2
      • created2025-02-13 09:05:35
      • modified2025-02-13 09:05:35
      • pathimg/screenshot_from_2025_02_12_15_02_21_4.png
    • 7(array)
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      • checksum6bc16b9365978e78648a538ca8d5f737
      • alternative(null)
      • groupimpd
      • descriptionUpdated Investigators Brochure/Package inserts or Investigational Medicinal Product Dossier (IMPD)
      • year2025
      • file_date13-02-2025
      • pocket_nameimpd
      • version_no2
      • created2025-02-13 09:06:17
      • modified2025-02-13 09:06:17
      • pathimg/screenshot_from_2025_02_12_15_02_21_5.png
    • 8(array)
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      • dirnameimg
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      • checksum6bc16b9365978e78648a538ca8d5f737
      • alternative(null)
      • groupdsur
      • descriptionThe Development Safety Update Report (DSUR)
      • year2025
      • file_date13-02-2025
      • pocket_namedsur
      • version_no2
      • created2025-02-13 09:06:30
      • modified2025-02-13 09:06:30
      • pathimg/screenshot_from_2025_02_12_15_02_21_6.png
    • 9(array)
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      • dirnameimg
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      • checksum6bc16b9365978e78648a538ca8d5f737
      • alternative(null)
      • grouperc
      • descriptionCopy of current favourable opinion letter from the local Ethics Review Committee (ERC).
      • year2025
      • file_date13-02-2025
      • pocket_nameerc
      • version_no1
      • created2025-02-13 09:06:44
      • modified2025-02-13 09:06:44
      • pathimg/screenshot_from_2025_02_12_15_02_21_7.png
    • 10(array)
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      • foreign_key127
      • dirnameimg
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      • checksum47a8ae9bdeed1883ea31e1a9c00373e6
      • alternative(null)
      • groupannual_practice_investigator
      • descriptionCopy of the Annual Practice License of the Investigators
      • year2025
      • file_date13-02-2025
      • pocket_nameannual_practice_investigator
      • version_no2
      • created2025-02-13 09:07:06
      • modified2025-02-13 09:07:06
      • pathimg/screenshot_from_2025_02_13_08_50_30_3.png
    • 11(array)
      • id1617
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      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2025_02_12_15_02_21_9.png
      • foreign_key127
      • dirnameimg
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      • checksum6bc16b9365978e78648a538ca8d5f737
      • alternative(null)
      • groupannual_practice_pharmacist
      • descriptionCopy of the Annual Practice License for the Pharmacist
      • year2025
      • file_date13-02-2025
      • pocket_nameannual_practice_pharmacist
      • version_no1
      • created2025-02-13 09:07:19
      • modified2025-02-13 09:07:19
      • pathimg/screenshot_from_2025_02_12_15_02_21_9.png
    • 12(array)
      • id1618
      • modelAnnualApproval
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2025_02_13_08_50_30_4.png
      • foreign_key127
      • dirnameimg
      • basenamescreenshot_from_2025_02_13_08_50_30_4.png
      • checksum47a8ae9bdeed1883ea31e1a9c00373e6
      • alternative(null)
      • groupindemnity_cover_investigator
      • descriptionCopy of the valid professional indemnity insurance cover for the investigators
      • year2025
      • file_date13-02-2025
      • pocket_nameindemnity_cover_investigator
      • version_no2
      • created2025-02-13 09:07:37
      • modified2025-02-13 09:07:37
      • pathimg/screenshot_from_2025_02_13_08_50_30_4.png
    • 13(array)
      • id1619
      • modelAnnualApproval
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2025_02_13_08_50_30_5.png
      • foreign_key127
      • dirnameimg
      • basenamescreenshot_from_2025_02_13_08_50_30_5.png
      • checksum47a8ae9bdeed1883ea31e1a9c00373e6
      • alternative(null)
      • groupindemnity_cover_pharmacist
      • descriptionCopy of the valid professional indemnity insurance cover for the study pharmacist
      • year2025
      • file_date13-02-2025
      • pocket_nameindemnity_cover_pharmacist
      • version_no2
      • created2025-02-13 09:07:51
      • modified2025-02-13 09:07:51
      • pathimg/screenshot_from_2025_02_13_08_50_30_5.png
    • 14(array)
      • id1620
      • modelAnnualApproval
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2025_02_12_15_02_21_10.png
      • foreign_key127
      • dirnameimg
      • basenamescreenshot_from_2025_02_12_15_02_21_10.png
      • checksum6bc16b9365978e78648a538ca8d5f737
      • alternative(null)
      • grouppan_african
      • descriptionEvidence of registration of the study at Pan African Clinical Trials Registry https://pactr.samrc.ac.za
      • year2025
      • file_date13-02-2025
      • pocket_namepan_african
      • version_no2
      • created2025-02-13 09:08:22
      • modified2025-02-13 09:08:22
      • pathimg/screenshot_from_2025_02_12_15_02_21_10.png
    • 15(array)
      • id1621
      • modelAnnualApproval
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2025_02_12_15_02_21_11.png
      • foreign_key127
      • dirnameimg
      • basenamescreenshot_from_2025_02_12_15_02_21_11.png
      • checksum6bc16b9365978e78648a538ca8d5f737
      • alternative(null)
      • groupsigned_checklist
      • descriptionA signed checklist confirming the submission of the document
      • year2025
      • file_date13-02-2025
      • pocket_namesigned_checklist
      • version_no3
      • created2025-02-13 09:08:37
      • modified2025-02-13 09:08:37
      • pathimg/screenshot_from_2025_02_12_15_02_21_11.png
  • AmendmentChecklist(array)
    • 0(array)
      • id1656
      • modelAmendmentChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2025_02_14_12_06_10.png
      • foreign_key127
      • dirnameimg
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      • checksum2713a7795c2a6a8f4a97b103fc7e9e16
      • alternative(null)
      • groupamendment_cover_letter
      • descriptionCover letter
      • yearamd-1
      • file_date(null)
      • pocket_nameamendment_cover_letter
      • version_no
      • created2025-02-14 12:20:36
      • modified2025-02-14 12:20:36
      • pathimg/screenshot_from_2025_02_14_12_06_10.png
    • 1(array)
      • id1657
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      • foreign_key127
      • dirnameimg
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      • checksum2713a7795c2a6a8f4a97b103fc7e9e16
      • alternative(null)
      • groupamendment_summary
      • descriptionSummary of the proposed amendment.
      • yearamd-1
      • file_date(null)
      • pocket_nameamendment_summary
      • version_no
      • created2025-02-14 12:20:39
      • modified2025-02-14 12:20:39
      • pathimg/screenshot_from_2025_02_14_12_06_10_2.png
    • 2(array)
      • id1658
      • modelAmendmentChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2025_02_14_12_06_10_3.png
      • foreign_key127
      • dirnameimg
      • basenamescreenshot_from_2025_02_14_12_06_10_3.png
      • checksum2713a7795c2a6a8f4a97b103fc7e9e16
      • alternative(null)
      • groupamendment_reason
      • descriptionReason for the amendment.
      • yearamd-1
      • file_date(null)
      • pocket_nameamendment_reason
      • version_no
      • created2025-02-14 12:20:43
      • modified2025-02-14 12:20:43
      • pathimg/screenshot_from_2025_02_14_12_06_10_3.png
    • 3(array)
      • id1659
      • modelAmendmentChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2025_02_14_12_06_10_4.png
      • foreign_key127
      • dirnameimg
      • basenamescreenshot_from_2025_02_14_12_06_10_4.png
      • checksum2713a7795c2a6a8f4a97b103fc7e9e16
      • alternative(null)
      • groupamendment_impacts
      • descriptionImpact of the amendment on the original study objectives.
      • yearamd-1
      • file_date(null)
      • pocket_nameamendment_impacts
      • version_no
      • created2025-02-14 12:20:49
      • modified2025-02-14 12:20:49
      • pathimg/screenshot_from_2025_02_14_12_06_10_4.png
    • 4(array)
      • id1660
      • modelAmendmentChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2025_02_14_12_06_10_5.png
      • foreign_key127
      • dirnameimg
      • basenamescreenshot_from_2025_02_14_12_06_10_5.png
      • checksum2713a7795c2a6a8f4a97b103fc7e9e16
      • alternative(null)
      • groupamendment_impacts_on_data_generated
      • descriptionImpact of the amendment on the data generated
      • yearamd-1
      • file_date(null)
      • pocket_nameamendment_impacts_on_data_generated
      • version_no
      • created2025-02-14 12:20:52
      • modified2025-02-14 12:20:52
      • pathimg/screenshot_from_2025_02_14_12_06_10_5.png
    • 5(array)
      • id1661
      • modelAmendmentChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2025_02_14_12_06_10_6.png
      • foreign_key127
      • dirnameimg
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      • checksum2713a7795c2a6a8f4a97b103fc7e9e16
      • alternative(null)
      • groupamendment_impacts_on_safety
      • descriptionImpact of the amendment on safety and well-being.
      • yearamd-1
      • file_date(null)
      • pocket_nameamendment_impacts_on_safety
      • version_no
      • created2025-02-14 12:20:55
      • modified2025-02-14 12:20:55
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    • 6(array)
      • id1662
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      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2025_02_14_12_06_10_7.png
      • foreign_key127
      • dirnameimg
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      • checksum2713a7795c2a6a8f4a97b103fc7e9e16
      • alternative(null)
      • groupamendment_cover_letter
      • descriptionCover letter
      • yearamd-1
      • file_date(null)
      • pocket_nameamendment_cover_letter
      • version_no
      • created2025-02-17 08:48:04
      • modified2025-02-17 08:48:04
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    • 7(array)
      • id1663
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      • file/var/www/ctr/app/webroot/media/transfer/gen/art_monthly_report_2025_02_17_11_55_58.xls
      • foreign_key127
      • dirnamegen
      • basenameart_monthly_report_2025_02_17_11_55_58.xls
      • checksum41bcb3bb9a7ca5ae0cb5dee3b3fcd36a
      • alternative(null)
      • groupamendment_summary
      • descriptionSummary of the proposed amendment.
      • yearamd-1
      • file_date(null)
      • pocket_nameamendment_summary
      • version_no3
      • created2025-02-18 08:50:07
      • modified2025-02-18 08:50:07
      • pathgen/art_monthly_report_2025_02_17_11_55_58.xls
    • 8(array)
      • id1664
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      • file/var/www/ctr/app/webroot/media/transfer/gen/line_list_of_all_client_2025_02_17_12_10_38_2.xls
      • foreign_key127
      • dirnamegen
      • basenameline_list_of_all_client_2025_02_17_12_10_38_2.xls
      • checksum933de56eb3c8ac93c17adc50d4be6375
      • alternative(null)
      • groupamendment_impacts_on_data_generated
      • descriptionImpact of the amendment on the data generated
      • yearamd-1
      • file_date(null)
      • pocket_nameamendment_impacts_on_data_generated
      • version_no
      • created2025-02-18 08:52:56
      • modified2025-02-18 08:52:56
      • pathgen/line_list_of_all_client_2025_02_17_12_10_38_2.xls
    • 9(array)
      • id1665
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      • file/var/www/ctr/app/webroot/media/transfer/gen/line_list_for_iit_clients_on_date_2025_02_17_11_35_17.xls
      • foreign_key127
      • dirnamegen
      • basenameline_list_for_iit_clients_on_date_2025_02_17_11_35_17.xls
      • checksum5107e03354dfa9f9f30b268229745dbb
      • alternative(null)
      • groupamendment_impacts_on_safety
      • descriptionImpact of the amendment on safety and well-being.
      • yearamd-1
      • file_date(null)
      • pocket_nameamendment_impacts_on_safety
      • version_no2
      • created2025-02-18 08:53:19
      • modified2025-02-18 08:53:19
      • pathgen/line_list_for_iit_clients_on_date_2025_02_17_11_35_17.xls
  • Reminder(empty)
  • ParticipantFlow(empty)
  • Budget(array)
    • 0(array)
      • id34
      • application_id127
      • year(null)
      • budget_period(null)
      • personnel_currencyKES
      • personnel10000
      • transport_currencyUSD
      • transport10000
      • field_currencyKES
      • field10000
      • supplies_currencyUSD
      • supplies10000
      • pharmacy_currencyKES
      • pharmacy10000
      • travel_currencyEUR
      • travel10000
      • regulatory_currencyKES
      • regulatory10000
      • it_currencyUSD
      • it10000
      • lab_currency(null)
      • lab(null)
      • others_currencyUSD
      • others10000
      • kemri_currency(null)
      • kemri(null)
      • wrair_currency(null)
      • wrair(null)
      • subject_currencyKES
      • subject10000
      • grand_currencyUSD
      • grand_total10000
      • study_informationMolestiae et harum e
      • personnel_kshs10000
      • transport_kshs10000
      • field_kshs10000
      • supplies_kshs10000
      • pharmacy_kshs10000
      • travel_kshs10000
      • regulatory_kshs10000
      • it_kshs10000
      • lab_kshs(null)
      • others_kshs10000
      • grand_total_kshs10000
      • subject_kshs10000
      • created2025-01-06 15:08:18
      • modified2025-02-06 14:33:08
  • 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)
      • id1159
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/approvalletter_14
      • foreign_key127
      • dirnamegen
      • basenameapprovalletter_14
      • checksumbc203cedbd1ce22aea7eb8303b486942
      • alternative(null)
      • groupapplicant_financial_declaration
      • descriptionFinancial declaration by Sponsor and/or PI *
      • year(null)
      • file_date06-01-2025
      • pocket_nameapplicant_financial_declaration
      • version_no
      • created2025-01-06 15:19:47
      • modified2025-02-06 14:33:08
      • pathgen/approvalletter_14
    • 1(array)
      • id1160
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/approvalletter_14
      • foreign_key127
      • dirnamegen
      • basenameapprovalletter_14
      • checksumbc203cedbd1ce22aea7eb8303b486942
      • alternative(null)
      • groupapplicant_protocol
      • descriptionThe Study Protocol *
      • year(null)
      • file_date07-01-2025
      • pocket_nameapplicant_protocol
      • version_no
      • created2025-01-07 07:56:43
      • modified2025-01-07 07:56:43
      • pathgen/approvalletter_14
    • 2(array)
      • id1161
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/approvalletter_14
      • foreign_key127
      • dirnamegen
      • basenameapprovalletter_14
      • checksumbc203cedbd1ce22aea7eb8303b486942
      • alternative(null)
      • groupapplicant_pan_african
      • descriptionRegistration of the study at Pan African Clinical Trials Registry https://pactr.samrc.ac.za *
      • year(null)
      • file_date07-01-2025
      • pocket_nameapplicant_pan_african
      • version_no
      • created2025-01-07 07:57:00
      • modified2025-01-07 07:57:00
      • pathgen/approvalletter_14
    • 3(array)
      • id1162
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/approvalletter_14
      • foreign_key127
      • dirnamegen
      • basenameapprovalletter_14
      • checksumbc203cedbd1ce22aea7eb8303b486942
      • alternative(null)
      • groupapplicant_patient_information
      • descriptionPatient Information leaflet and Informed consent form *
      • year(null)
      • file_date07-01-2025
      • pocket_nameapplicant_patient_information
      • version_no1
      • created2025-01-07 07:58:49
      • modified2025-01-07 07:58:49
      • pathgen/approvalletter_14
    • 4(array)
      • id1163
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/approvalletter_14
      • foreign_key127
      • dirnamegen
      • basenameapprovalletter_14
      • checksumbc203cedbd1ce22aea7eb8303b486942
      • alternative(null)
      • groupapplicant_investigators_brochure
      • descriptionInvestigators Brochure/Package inserts *
      • year(null)
      • file_date07-01-2025
      • pocket_nameapplicant_investigators_brochure
      • version_no
      • created2025-01-07 07:59:32
      • modified2025-01-07 07:59:32
      • pathgen/approvalletter_14
    • 5(array)
      • id1164
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/approvalletter_14
      • foreign_key127
      • dirnamegen
      • basenameapprovalletter_14
      • checksumbc203cedbd1ce22aea7eb8303b486942
      • alternative(null)
      • groupapplicant_impd
      • descriptionInvestigational Medicinal Product Dossier (IMPD) *
      • year(null)
      • file_date07-01-2025
      • pocket_nameapplicant_impd
      • version_no2.1
      • created2025-01-07 08:00:03
      • modified2025-01-07 08:00:03
      • pathgen/approvalletter_14
    • 6(array)
      • id1165
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/approvalletter_14
      • foreign_key127
      • dirnamegen
      • basenameapprovalletter_14
      • checksumbc203cedbd1ce22aea7eb8303b486942
      • alternative(null)
      • groupapplicant_gmp_certificate
      • descriptionGMP certificate of the investigational product from the site of manufacture *
      • year(null)
      • file_date07-01-2025
      • pocket_nameapplicant_gmp_certificate
      • version_no
      • created2025-01-07 08:03:28
      • modified2025-01-07 08:03:28
      • pathgen/approvalletter_14
    • 7(array)
      • id1166
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/approvalletter_14
      • foreign_key127
      • dirnamegen
      • basenameapprovalletter_14
      • checksumbc203cedbd1ce22aea7eb8303b486942
      • alternative(null)
      • groupapplicant_gcp_training
      • descriptionEvidence of recent GCP training of the core study staff *
      • year(null)
      • file_date07-01-2025
      • pocket_nameapplicant_gcp_training
      • version_no2
      • created2025-01-07 08:04:16
      • modified2025-01-07 08:04:16
      • pathgen/approvalletter_14
    • 8(array)
      • id1167
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/approvalletter_14
      • foreign_key127
      • dirnamegen
      • basenameapprovalletter_14
      • checksumbc203cedbd1ce22aea7eb8303b486942
      • 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_date07-01-2025
      • pocket_nameapplicant_prev_data
      • version_no
      • created2025-01-07 08:04:43
      • modified2025-01-07 08:04:43
      • pathgen/approvalletter_14
    • 9(array)
      • id1168
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/approvalletter_14
      • foreign_key127
      • dirnamegen
      • basenameapprovalletter_14
      • checksumbc203cedbd1ce22aea7eb8303b486942
      • alternative(null)
      • groupapplicant_stability_data
      • descriptionStability data of the investigational product *
      • year(null)
      • file_date07-01-2025
      • pocket_nameapplicant_stability_data
      • version_no
      • created2025-01-07 08:05:03
      • modified2025-01-07 08:05:03
      • pathgen/approvalletter_14
    • 10(array)
      • id1169
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/approvalletter_14
      • foreign_key127
      • dirnamegen
      • basenameapprovalletter_14
      • checksumbc203cedbd1ce22aea7eb8303b486942
      • alternative(null)
      • groupapplicant_analysis_cert
      • descriptionCertificate of Analysis of the investigational product *
      • year(null)
      • file_date07-01-2025
      • pocket_nameapplicant_analysis_cert
      • version_no
      • created2025-01-07 08:05:37
      • modified2025-01-07 08:05:37
      • pathgen/approvalletter_14
    • 11(array)
      • id1170
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/approvalletter_14
      • foreign_key127
      • dirnamegen
      • basenameapprovalletter_14
      • checksumbc203cedbd1ce22aea7eb8303b486942
      • 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_date(null)
      • pocket_nameapplicant_pictorial_sample
      • version_no
      • created2025-01-07 08:06:04
      • modified2025-01-07 08:06:04
      • pathgen/approvalletter_14
    • 12(array)
      • id1171
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/approvalletter_14
      • foreign_key127
      • dirnamegen
      • basenameapprovalletter_14
      • checksumbc203cedbd1ce22aea7eb8303b486942
      • 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_date07-01-2025
      • pocket_nameapplicant_investigators_cv
      • version_no
      • created2025-01-07 08:06:56
      • modified2025-01-07 08:06:56
      • pathgen/approvalletter_14
    • 13(array)
      • id1172
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/approvalletter_14
      • foreign_key127
      • dirnamegen
      • basenameapprovalletter_14
      • checksumbc203cedbd1ce22aea7eb8303b486942
      • alternative(null)
      • groupapplicant_dsmb_charter
      • descriptionDSMB Charter including the composition and meeting schedule *
      • year(null)
      • file_date07-01-2025
      • pocket_nameapplicant_dsmb_charter
      • version_no
      • created2025-01-07 08:07:20
      • modified2025-01-07 08:07:20
      • pathgen/approvalletter_14
    • 14(array)
      • id1173
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/approvalletter_14
      • foreign_key127
      • dirnamegen
      • basenameapprovalletter_14
      • checksumbc203cedbd1ce22aea7eb8303b486942
      • alternative(null)
      • groupapplicant_detailed_budget
      • descriptionDetailed budget of the study *
      • year(null)
      • file_date(null)
      • pocket_nameapplicant_detailed_budget
      • version_no
      • created2025-01-07 08:07:32
      • modified2025-01-07 08:07:32
      • pathgen/approvalletter_14
    • 15(array)
      • id1174
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/approvalletter_14
      • foreign_key127
      • dirnamegen
      • basenameapprovalletter_14
      • checksumbc203cedbd1ce22aea7eb8303b486942
      • alternative(null)
      • groupapplicant_indemnity_pi
      • descriptionIndemnity cover for PI, investigators and study Pharmacist. *
      • year(null)
      • file_date07-01-2025
      • pocket_nameapplicant_indemnity_pi
      • version_no
      • created2025-01-07 08:07:56
      • modified2025-01-07 08:07:56
      • pathgen/approvalletter_14
    • 16(array)
      • id1175
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/approvalletter_14
      • foreign_key127
      • dirnamegen
      • basenameapprovalletter_14
      • checksumbc203cedbd1ce22aea7eb8303b486942
      • 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_date07-01-2025
      • pocket_nameapplicant_signed_declaration
      • version_no
      • created2025-01-07 08:08:10
      • modified2025-01-07 08:08:10
      • pathgen/approvalletter_14
    • 17(array)
      • id1176
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/approvalletter_14
      • foreign_key127
      • dirnamegen
      • basenameapprovalletter_14
      • checksumbc203cedbd1ce22aea7eb8303b486942
      • alternative(null)
      • groupapplicant_indemnity_cover
      • descriptionClinical Trials Insurance cover for study participants *
      • year(null)
      • file_date07-01-2025
      • pocket_nameapplicant_indemnity_cover
      • version_no
      • created2025-01-07 08:08:53
      • modified2025-01-07 08:08:53
      • pathgen/approvalletter_14
    • 18(array)
      • id1177
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/approvalletter_14
      • foreign_key127
      • dirnamegen
      • basenameapprovalletter_14
      • checksumbc203cedbd1ce22aea7eb8303b486942
      • alternative(null)
      • groupapplicant_opinion_letter
      • descriptionCopy of favorable opinion letter from the local Ethics Review Committee (ERC). *
      • year(null)
      • file_date07-01-2025
      • pocket_nameapplicant_opinion_letter
      • version_no
      • created2025-01-07 08:09:11
      • modified2025-01-07 08:09:11
      • pathgen/approvalletter_14
    • 19(array)
      • id1178
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/approvalletter_14
      • foreign_key127
      • dirnamegen
      • basenameapprovalletter_14
      • checksumbc203cedbd1ce22aea7eb8303b486942
      • alternative(null)
      • groupapplicant_practice_license
      • descriptionCopy of current Practice Licenses for the Investigators and study Pharmacist *
      • year(null)
      • file_date07-01-2025
      • pocket_nameapplicant_practice_license
      • version_no3
      • created2025-01-07 08:09:31
      • modified2025-01-07 08:09:31
      • pathgen/approvalletter_14
    • 20(array)
      • id1179
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/approvalletter_14
      • foreign_key127
      • dirnamegen
      • basenameapprovalletter_14
      • checksumbc203cedbd1ce22aea7eb8303b486942
      • alternative(null)
      • groupapplicant_approval_letter
      • descriptionCopy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable *
      • year(null)
      • file_date07-01-2025
      • pocket_nameapplicant_approval_letter
      • version_no
      • created2025-01-07 08:14:33
      • modified2025-01-07 08:14:33
      • pathgen/approvalletter_14
    • 21(array)
      • id1180
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/approvalletter_14
      • foreign_key127
      • dirnamegen
      • basenameapprovalletter_14
      • checksumbc203cedbd1ce22aea7eb8303b486942
      • 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_date07-01-2025
      • pocket_nameapplicant_addendum
      • version_no
      • created2025-01-07 08:14:47
      • modified2025-01-07 08:14:47
      • pathgen/approvalletter_14
    • 22(array)
      • id1181
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/approvalletter_14
      • foreign_key127
      • dirnamegen
      • basenameapprovalletter_14
      • checksumbc203cedbd1ce22aea7eb8303b486942
      • 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_date07-01-2025
      • pocket_nameapplicant_statement
      • version_no
      • created2025-01-07 08:15:00
      • modified2025-01-07 08:15:00
      • pathgen/approvalletter_14
    • 23(array)
      • id1182
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/approvalletter_14
      • foreign_key127
      • dirnamegen
      • basenameapprovalletter_14
      • checksumbc203cedbd1ce22aea7eb8303b486942
      • alternative(null)
      • groupapplicant_fees
      • descriptionPayment of fees *
      • year(null)
      • file_date07-01-2025
      • pocket_nameapplicant_fees
      • version_no
      • created2025-01-07 08:15:11
      • modified2025-01-07 08:15:11
      • pathgen/approvalletter_14
    • 24(array)
      • id1183
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/approvalletter_14
      • foreign_key127
      • dirnamegen
      • basenameapprovalletter_14
      • checksumbc203cedbd1ce22aea7eb8303b486942
      • alternative(null)
      • groupstatistical_analysis_plan
      • descriptionStatistical Analysis Plan *
      • year(null)
      • file_date07-01-2025
      • pocket_namestatistical_analysis_plan
      • version_no
      • created2025-01-07 08:15:23
      • modified2025-01-07 08:15:23
      • pathgen/approvalletter_14
    • 25(array)
      • id1184
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/approvalletter_14
      • foreign_key127
      • dirnamegen
      • basenameapprovalletter_14
      • checksumbc203cedbd1ce22aea7eb8303b486942
      • alternative(null)
      • groupapplicant_signed_checklist
      • descriptionSigned Checklist *
      • year(null)
      • file_date07-01-2025
      • pocket_nameapplicant_signed_checklist
      • version_no
      • created2025-01-07 08:15:38
      • modified2025-01-07 08:15:42
      • pathgen/approvalletter_14
    • 26(array)
      • id1566
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/img/screenshot_from_2025_02_04_14_23_28.png
      • foreign_key127
      • dirnameimg
      • basenamescreenshot_from_2025_02_04_14_23_28.png
      • checksumf7c57341c9e4899a15c9636ab5d7c0f6
      • alternative(null)
      • groupapplicant_covering_letter
      • descriptionCover Letter (Should list all the submitted documents, their version numbers and dates) *
      • year(null)
      • file_date06-02-2025
      • pocket_nameapplicant_covering_letter
      • version_no3
      • created2025-02-06 14:32:52
      • modified2025-02-06 14:32:59
      • pathimg/screenshot_from_2025_02_04_14_23_28.png
  • StudyMonitor(empty)
  • ProtocolOutsource(empty)
  • Outsource(array)
    • 0(array)
      • id7
      • application_id127
      • user_id847
      • model
      • usernamej1outsourcer
      • namejavanoutsorcer
      • emailj1outsourcer@gmail.com
      • phone_no+254702674563
      • institution_physical
      • name_of_institution
      • institution_address
      • institution_contact
      • county_id(null)
      • country_id115
      • approved1
      • created2025-01-07 08:57:17
      • modified2025-08-08 12:03:57
      • accepted(null)
      • model_sae1
      • model_ciom0
      • model_dev1
• 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