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  • Application(array)
    • id1551
    • user_id1000
    • trial_status_id(null)
    • abstract_of_study<p> This study aims to advance the accuracy and reliability of the Binah.ai algorithm in the Kenyan population. Subjects will be recorded using the Binah.ai Recorder and their vital signs (pulse rate, oxygen saturation and blood pressure) and blood samples will be collected using reference devices and lab tests. A total of 20,000 participants will be recruited globally (Italy, India, Israel, Japan, USA), including 1,000 participants that will be enrolled in Zuri Health Medical Center, Kenya. The process includes training the algorithm with the newly collected data. Once the training is completed, new data collected will be used to validate the performance of the improved algorithm. We expect that this data collection study will improve the overall algorithm performance among the Kenyan population.</p>
    • study_title<p> Physiological and Biomarker Monitoring: Enhancing Vital Signs and Biomarkers Algorithm of Binah.AI in the Kenyan Population</p>
    • laymans_summary<p data-end="362" data-start="0"> This study wants to make sure the Binah.ai health application works well for people in Kenya. The application checks your vital signs like heart rate, oxygen levels, and blood pressure just by using a smartphone. To do this, researchers will record volunteers using the Binah.ai Recorder and also check their vital signs and blood using standard medical equipment and lab tests.</p> <p data-end="694" data-start="364"> In total, 20,000 people from around the world will take part, including 1,000 people in Kenya at Zuri Health Medical Center. The information collected will help train the application to better understand health signs in different people. After this training, researchers will test the updated application to see if it gives more accurate results.</p> <p data-end="795" data-is-last-node="" data-is-only-node="" data-start="696"> The goal is to make sure the application works well and gives reliable health readings for people in Kenya.</p> <p>  </p>
    • short_titleZHR-001
    • protocol_noECCT/25/06/03
    • version_no3.0
    • date_of_protocol14-05-2025
    • study_drugBinah.ai recorder
    • disease_conditionVital signs
    • product_type_biologicals0
    • product_type_proteins0
    • product_type_immunologicals0
    • product_type_vaccines0
    • product_type_hormones0
    • product_type_toxoid0
    • product_type_chemical0
    • product_type_medical_device1
    • product_type_chemical_name
    • product_type_medical_device_nameBinah.ai recorder
    • comparatorNo
    • comparator_name
    • comparator_registered
    • comparator_countries
    • ecct_not_applicable0
    • ecct_ref_number
    • email_addresszurihealthresearch@gmail.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_addendum0
    • applicant_fees1
    • applicant_complete_form(null)
    • applicant_impd1
    • applicant_prev_data1
    • applicant_stability_data1
    • applicant_analysis_cert1
    • applicant_pictorial_sample1
    • applicant_gcp_training1
    • applicant_dsmb_charter1
    • applicant_detailed_budget1
    • applicant_indemnity_pi1
    • applicant_practice_license1
    • applicant_registration_ctr(null)
    • applicant_pan_african1
    • applicant_hard_copies(null)
    • applicant_signed_checklist1
    • statistical_analysis_plan1
    • applicant_contractual_agreement1
    • declaration_applicantDr. Borna Nyaoke
    • declaration_date111-07-2025
    • declaration_principal_investigatorDr. Borna Nyaoke
    • declaration_date211-07-2025
    • placebo_presentNo
    • study_objectives<p style="margin-left:.75in;"> Collection of subjects recordings using the Binah.ai Recorder, and vital sign data and blood samples using reference devices and lab tests to enhance the Binah.ai algorithm performance on the population of Kenya.</p> <h2>  </h2> <p>  </p>
    • principal_inclusion_criteria<ol> <li> The subject must have the ability to understand and provide written informed consent.</li> <li> Male or Female subjects ≥18 and ≤65 of age.</li> <li> The subject must be willing and able to comply with study procedures.</li> <li> Subjects with the following co-morbid conditions.</li> </ol> <p style="margin-left:106.35pt;"> <em>Note: Healthy subjects without the following conditions are still eligible</em></p> <ol style="list-style-type:lower-roman;"> <li> Subject with Pre-diabetes or diabetes HbA1C 6.4-16%</li> <li> Subject with Hypertension with systolic measurements above 145 mmHg</li> <li> Subject with Total cholesterol with measurements of   >240 mg/dl or higher</li> <li> Subjects who are active smokers</li> </ol> <p>  </p>
    • principal_exclusion_criteria<ol> <li> The subject has compromised circulation, injury, or physical malformation of fingers, hands, ears or forehead/skull or other sensor Region of Interest (ROI) which would limit the ability to test ROI needed for the study.</li> </ol> <p style="margin-left:99.25pt;"> <em>Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular areas utilized.</em></p> <ol> <li value="2"> The subject has a tattoo in the optical path which would limit the ability to conduct the tests needed for the study.</li> <li value="3"> Subjects with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, respiration monitor electrodes or other medical sensors used for measuring vital signs.</li> <li value="4"> Subject with a medical condition which in the opinion of the investigator, does not allow performing the study assessments.</li> <li value="5"> Subject unfit to participate in the study to the judgment of the investigator.</li> </ol> <p>  </p>
    • primary_end_points<p style="margin-left:49.65pt;"> Record 1000 subject’s vitals including: blood pressure, pulse rate and oxygen saturation using the Binah.ai recorder and reference devices. The data will be gathered by trained personnel and used to train and validate the Binah.ai algorithm to enhance the accuracy and reliability among the Kenyan population.</p> <p>  </p>
    • scope_diagnosis0
    • scope_prophylaxis0
    • scope_therapy0
    • scope_safety0
    • scope_efficacy0
    • scope_pharmacokinetic0
    • scope_pharmacodynamic0
    • scope_bioequivalence0
    • scope_dose_response0
    • scope_pharmacogenetic0
    • scope_pharmacogenomic0
    • scope_pharmacoecomomic0
    • scope_others1
    • scope_others_specifyAlgorithim testing
    • trial_human_pharmacology0
    • trial_administration_humans0
    • trial_bioequivalence_study0
    • trial_other1
    • trial_other_specifyMedical device exploratory
    • trial_therapeutic_exploratory0
    • trial_therapeutic_confirmatory0
    • trial_therapeutic_use0
    • design_controlledNo
    • site_capacity(null)
    • staff_numbers<p> The study will be conducted at Zuri Health medical center, a Level III registered health facility in Nairobi which provides comprehensive primary healthcare services through a team of over 50 staff, including 30 clinical professionals (doctors, nurses, clinical officers, nutritionists, lab technicians, and pharmacists). Since launching in 2021, Zuri Health medical center has served over 200,000 patients, attending to approximately 100 patients weekly. Zuri Health medical center works with corporates and foundations to carry out wellness screenings and medical camps across the county with over 12,000 patients seen in Nairobi in 2024. Patients with non-communicable diseases diagnosed during the wellness screenings or medical camps are under follow-up at the medical center in the continuous care program</p> <p> Screening of all participants will be conducted at the Zuri Health Medical Center and consenting of study participants will take place in a private room at the medical centre by the Principal Investigator or designee.</p> <p> Principal Investigator- Dr. Borna Nyaoke MBChB,MPH- over 14 years of clinical trial experience</p> <p> Co-Investigator- Dr. Barbara Tarno MBChB</p> <p>  </p>
    • other_details_explanation<p> The study has also been conducted in the USA, Israel and India</p>
    • other_details_regulatory_notapproved<p> N/A</p>
    • other_details_regulatory_approved<p> Ethics Approval: </p> <p> Lokmanya Medical Research Center Ethical Committee, Pune, India- 1000 subjects- 1 site</p> <p> Salus IRB, Austin, Texas, USA- 1000 subjects- 1 site</p>
    • other_details_regulatory_rejected<p> N/A</p>
    • other_details_regulatory_halted<p> N/A</p>
    • estimated_duration6 months
    • 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_stateYes
    • location_of_areaZuri Health Medical Centre
    • single_site_physical_address132 Manyani East Road, Nairobi, Kenya
    • single_site_contact_personDr. Borna Nyaoke
    • single_site_telephone0720734479
    • multiple_sites_member_stateNo
    • multiple_countriesYes
    • multiple_member_states5
    • number_of_sites
    • multi_country_listItaly, India, Israel, Japan, USA
    • data_monitoring_committeeNo
    • total_enrolment_per_site1000
    • total_participants_worldwide20000
    • population_less_than_18_yearsNo
    • population_uteroNo
    • population_preterm_newbornNo
    • population_newbornNo
    • population_infant_and_toddlerNo
    • population_childrenNo
    • population_adolescentNo
    • population_above_18Yes
    • population_adultYes
    • population_elderlyNo
    • gender_female1
    • gender_male1
    • subjects_healthyYes
    • subjects_patientsYes
    • subjects_vulnerable_populationsYes
    • subjects_women_child_bearingYes
    • subjects_women_using_contraceptionYes
    • subjects_pregnant_womenNo
    • subjects_nursing_womenNo
    • subjects_emergency_situationNo
    • subjects_incapable_consentNo
    • subjects_specify
    • subjects_othersNo
    • subjects_others_specify
    • investigator1_given_nameBorna
    • investigator1_middle_nameAchieng
    • investigator1_family_nameNyaoke
    • investigator1_qualificationMBChB MPH
    • investigator1_professional_address132 Manyani East Road, Nairobi, Kenya
    • investigator1_telephone0756551551
    • investigator1_emailbornanyaoke12@gmail.com
    • organisations_transferred_No
    • number_participants1000
    • notification
    • approval_date21-11-2025
    • submitted1
    • deleted0
    • deleted_date(null)
    • deactivated0
    • date_submitted19-06-2025
    • is_child0
    • unsubmitted1
    • initial_date_submitted19-06-2025
    • admin_stopped0
    • admin_stopped_reason(null)
    • approved2
    • approved_reasonReviewer comments have been addressed.
    • final_report(null)
    • implication_results(null)
    • quantity_imported(null)
    • quantity_dispensed(null)
    • quantity_destroyed(null)
    • quantity_exported(null)
    • balance_site(null)
    • final_date(null)
    • modified2025-11-21 11:27:20
    • created2025-05-22 01:13:23
    • total_sites1
    • ecitizen_invoice375575
  • User(array)
    • id1000
    • usernamezurihealth
    • passwordeae84ebfe9384483aef40f0bb05e9134dd17e304
    • confirm_passwordeae84ebfe9384483aef40f0bb05e9134dd17e304
    • nameZuri Health
    • emailzurihealthresearch@gmail.com
    • national_id_number(null)
    • sponsor(null)
    • sponsor_emailbornanyaoke12@gmail.com
    • qualificationMBChB
    • phone_no0720734479
    • name_of_institutionZuri Health Medical Center
    • institution_physical
    • institution_address
    • institution_contact
    • county_id47
    • country_id115
    • group_id5
    • activation_key
    • forgot_password(null)
    • is_active1
    • deactivated0
    • created2025-05-22 01:09:31
    • modified2025-05-22 01:09:54
  • TrialStatus(array)
    • id(null)
    • value(null)
    • name(null)
    • created(null)
    • modified(null)
  • Review(array)
    • 0(array)
      • id4113
      • user_id549
      • application_id1551
      • typerequest
      • assessment_type(null)
      • titlePPB request
      • textFind allocated for review
      • summary(null)
      • recommendation
      • notified0
      • acceptedaccepted
      • conflictNo
      • statusUnsubmitted
      • created2025-07-30 11:45:41
      • modified2025-08-05 10:43:49
    • 1(array)
      • id4114
      • user_id551
      • application_id1551
      • typerequest
      • assessment_type(null)
      • titlePPB request
      • textFind allocated for review
      • summary(null)
      • recommendation
      • notified0
      • acceptedaccepted
      • conflictNo
      • statusUnsubmitted
      • created2025-07-30 11:45:41
      • modified2025-07-31 08:45:12
    • 2(array)
      • id4115
      • user_id555
      • application_id1551
      • typerequest
      • assessment_type(null)
      • titlePPB request
      • textFind allocated for review
      • summary(null)
      • recommendation
      • notified0
      • acceptedaccepted
      • conflictNo
      • statusUnsubmitted
      • created2025-07-30 11:45:41
      • modified2025-08-04 00:21:04
    • 3(array)
      • id4159
      • user_id549
      • application_id1551
      • typereviewer_comment
      • assessment_typeclinical
      • title(null)
      • text(null)
      • summaryThe protocol is well designed can the investigator clarify the following • if the bi application will purely be observational for validation or also inform care for clinical use ,If there’s any clinical use, kindly define safeguards, escalation pathways, and stopping rules for false highs/lows (e.g., BP, SpO₂) especially by providing a powered validation plan against gold-standard devices. Would it replace clinical assessment? Has the software device align with ppb pathway for device registration? How does the investigator ensure fair participant selection, equity and representation considering diversity in skin tones?
      • recommendationkindly clarify these concerns
      • notified0
      • accepted(null)
      • conflict(null)
      • statusSummary
      • created2025-08-25 10:30:22
      • modified2025-08-25 11:02:23
    • 4(array)
      • id4171
      • user_id846
      • application_id1551
      • typeppb_comment
      • assessment_type(null)
      • title(null)
      • text<ol> <li> <span style="font-size:14px;"><span style="font-family:bookman old style,serif;"><span style="caret-color: rgb(102, 102, 102);">Kindly clarify if the bi application will purely be observational for validation or also inform care for clinical use</span></span></span></li> <li> <span style="font-size:14px;"><span style="font-family:bookman old style,serif;"><span style="caret-color: rgb(102, 102, 102);">Additionally, if there’s any clinical use, kindly define safeguards, escalation pathways, and stopping rules for false highs/lows (e.g., BP, SpO₂) especially by providing a powered validation plan against gold-standard devices. Would it replace clinical assessment? </span></span></span></li> <li> <span style="font-size:14px;"><span style="font-family:bookman old style,serif;"><span style="caret-color: rgb(102, 102, 102);">Has the software device align with ppb pathway for device registration? </span></span></span></li> <li> <span style="font-size:14px;"><span style="font-family:bookman old style,serif;"><span style="caret-color: rgb(102, 102, 102);">How does the investigator ensure fair participant selection, equity and representation considering diversity in skin tones?</span></span></span></li> </ol>
      • summary(null)
      • recommendation<p> Kindly address the preliminary queries raised.</p>
      • notified0
      • accepted(null)
      • conflict(null)
      • statusUnsubmitted
      • created2025-09-08 13:05:08
      • modified2025-09-08 13:05:08
    • 5(array)
      • id4178
      • user_id551
      • application_id1551
      • typereviewer_comment
      • assessment_typeclinical
      • title(null)
      • text(null)
      • summaryInclusion criteria comments The study anticipates to enrol participants with diverse medical conditions, but also participants with significant medical conditions will be excluded as per investigators judgement; therefore, are there exclusionary condtions? Study plan and design comments There is no 'risk/benefits' section in the protocol. Kindly clarify. 1.5.1 REQUESTS FOR ADDITIONAL INFORMATION 1. The study anticipates to enroll participants with diverse medical conditions, but also participants with significant medical conditions will be excluded as per investigators judgement; therefore, are there exclusionary conditions? 2. To include study risks.
      • recommendation(null)
      • notified0
      • accepted(null)
      • conflict(null)
      • statusSubmitted
      • created2025-09-11 09:03:48
      • modified2025-09-11 09:14:02
    • 6(array)
      • id4192
      • user_id846
      • application_id1551
      • typeppb_comment
      • assessment_type(null)
      • title(null)
      • text<ol> <li> <span style="font-size:14px;"><span style="font-family:bookman old style,serif;"><span style="caret-color: rgb(102, 102, 102);">The study anticipates to enroll participants with diverse medical conditions, but also participants with significant medical conditions will be excluded as per investigators judgement; therefore, are there exclusionary conditions? Kindly specify</span></span></span></li> <li> <span style="font-size:14px;"><span style="font-family:bookman old style,serif;"><span style="caret-color: rgb(102, 102, 102);">Kindly include study risks.</span></span></span></li> </ol>
      • summary(null)
      • recommendation<p> Kindly address additional rqueries raised.</p>
      • notified0
      • accepted(null)
      • conflict(null)
      • statusUnsubmitted
      • created2025-09-29 10:36:01
      • modified2025-09-29 10:36:01
    • 7(array)
      • id4235
      • user_id846
      • application_id1551
      • typeppb_comment
      • assessment_type(null)
      • title(null)
      • text<ol> <li> <b style="color: rgb(0, 0, 0); font-family: "Times New Roman";">.</b><span style="color: rgb(0, 0, 0); font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"><b> </b></span><b style="color: rgb(0, 0, 0); font-family: "Times New Roman";">Study Objectives</b></li> </ol> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> <i>“We hereby submit for your review the above protocol which aims to advance the accuracy </i><i>and reliability of the Binah.ai algorithm in the Kenyan population “(Abstract, page 11).</i></p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> <span style="font-stretch: normal; line-height: normal; font-family: Helvetica; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"></span><span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>What is the exact objective of the study, to validate binah.ai, which has not been approved by FDA since submission in 2022 (as per literature), to gather more data to</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> support its approval, or is it a proof of concept?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> <span style="font-stretch: normal; line-height: normal; font-family: Helvetica; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"></span><span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>The binah.ai website appears to suggest/indicate that the system is more of a commercial venture as per the statement:<i> “Support For Your Business’s Needs”</i> [1].</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> a)<span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>Are there publications to prove the efficacy of this algorithm?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> b)<span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>If not, what supports its use in humans including its use in some risky procedures described in 3 below?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> c)<span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>What is the justification of using the unproved system in Kenyan patients?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> <b>2.</b><span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"><b> </b></span><b>Protocol</b></p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> <span style="font-stretch: normal; line-height: normal; font-family: Helvetica; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"></span><span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>In as much as the study will be carried globally in five countries and on over 20,000 participants (page 11), the presented protocol, including the references appears to indicate that it is purely a Kenyan protocol (i.e. a Kenyan site addendum).</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> a)<span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>The investigators should provide a copy of the universal (main) protocol that would provide consistency of the study and results?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> b)<span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>Who is the overall PI for this study across the five countries?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> c)Is the study designed to be carried differently across the five countries?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> d)If so, why the lack of uniformity?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> e)Will some of the procedures that may not necessarily be accepted in US and Europe be carried out in Kenya?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> <b>3.</b><span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"><b> </b></span><b>Study Procedures</b></p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> a)<span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>Some of the procedures appear to be dangerous, such as temporarily withholding oxygen supplementation from a participant in order for the <i>“By face” </i>experiment</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> described on page 26.</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> b)<span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>Patients on oxygen supplementation are very sick patients who continuously require oxygen. What happens if the participant undergoes respiratory distress and coma</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> resulting from this action?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> c)<span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>Are the researcher’s medical officers who are well trained to manage any complications resulting from this action?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> d)<span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>Does this meet ethical considerations?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> e)Is this kind of procedure acceptable in US and Europe, or Japan? <i>Or</i> is it only carried out in Kenya, but not in all the five countries?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> f)<span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>Could this be part of the reasons why the study lacks a universal Protocol?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> <b>4.</b><span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"><b> </b></span><b>Interventions</b></p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> <span style="font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;">1</span>a)<span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>What happens to patients who are found out/diagnosed to have some life threating conditions, such as severe blood pressure, diabetes and other life threatening events?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> b)<span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>Will any interventions be carried out post diagnosis?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> c)<span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>Where will the patients be managed, and at whose cost?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> <b>5.</b><span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"><b> </b></span><b>Exploratory Endpoint (page 21)</b></p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> a)<span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>The objectives of the exploratory tests using the patients’ blood described in page 21 should be clarified</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> b)<span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>What kind of tests will be carried out?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> c)Will it involve genetic tests?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> d)Will the tests be done locally, at the site, or with blood samples/products be shipped out of the country?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> <b>6.</b><span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"><b> </b></span><b>Triage/consenting process (page 34)</b></p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> <span style="font-stretch: normal; line-height: normal; font-family: Helvetica; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"></span><span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>How will the consenting process be carried out so as to inform the participant on all the desired tests and potential benefits</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> <span style="font-stretch: normal; line-height: normal; font-family: Helvetica; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"></span><span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>The Consent forms have not been provided in the current protocol. They should be provided.</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> <b>References</b></p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> 1. Binah.ai, Health Checks Anywherewe: The #1 AI-Powered Health and Wellness Check</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> Software, Available at: <span style="color: #0b4cb4">https://www.binah.ai/</span></p>
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      • recommendation<p> <span style="color:#000000;"><span style="font-size:14px;"><span style="font-family:bookman old style,serif;">Kindly address the comments raised</span></span></span></p>
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      • created2025-10-13 11:02:55
      • modified2025-10-13 11:02:55
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      • id4113
      • user_id549
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      • created2025-07-30 11:45:41
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      • user_id551
      • application_id1551
      • typerequest
      • assessment_type(null)
      • titlePPB request
      • textFind allocated for review
      • summary(null)
      • recommendation
      • notified0
      • acceptedaccepted
      • conflictNo
      • statusUnsubmitted
      • created2025-07-30 11:45:41
      • modified2025-07-31 08:45:12
    • 2(array)
      • id4115
      • user_id555
      • application_id1551
      • typerequest
      • assessment_type(null)
      • titlePPB request
      • textFind allocated for review
      • summary(null)
      • recommendation
      • notified0
      • acceptedaccepted
      • conflictNo
      • statusUnsubmitted
      • created2025-07-30 11:45:41
      • modified2025-08-04 00:21:04
    • 3(array)
      • id4159
      • user_id549
      • application_id1551
      • typereviewer_comment
      • assessment_typeclinical
      • title(null)
      • text(null)
      • summaryThe protocol is well designed can the investigator clarify the following • if the bi application will purely be observational for validation or also inform care for clinical use ,If there’s any clinical use, kindly define safeguards, escalation pathways, and stopping rules for false highs/lows (e.g., BP, SpO₂) especially by providing a powered validation plan against gold-standard devices. Would it replace clinical assessment? Has the software device align with ppb pathway for device registration? How does the investigator ensure fair participant selection, equity and representation considering diversity in skin tones?
      • recommendationkindly clarify these concerns
      • notified0
      • accepted(null)
      • conflict(null)
      • statusSummary
      • created2025-08-25 10:30:22
      • modified2025-08-25 11:02:23
    • 4(array)
      • id4171
      • user_id846
      • application_id1551
      • typeppb_comment
      • assessment_type(null)
      • title(null)
      • text<ol> <li> <span style="font-size:14px;"><span style="font-family:bookman old style,serif;"><span style="caret-color: rgb(102, 102, 102);">Kindly clarify if the bi application will purely be observational for validation or also inform care for clinical use</span></span></span></li> <li> <span style="font-size:14px;"><span style="font-family:bookman old style,serif;"><span style="caret-color: rgb(102, 102, 102);">Additionally, if there’s any clinical use, kindly define safeguards, escalation pathways, and stopping rules for false highs/lows (e.g., BP, SpO₂) especially by providing a powered validation plan against gold-standard devices. Would it replace clinical assessment? </span></span></span></li> <li> <span style="font-size:14px;"><span style="font-family:bookman old style,serif;"><span style="caret-color: rgb(102, 102, 102);">Has the software device align with ppb pathway for device registration? </span></span></span></li> <li> <span style="font-size:14px;"><span style="font-family:bookman old style,serif;"><span style="caret-color: rgb(102, 102, 102);">How does the investigator ensure fair participant selection, equity and representation considering diversity in skin tones?</span></span></span></li> </ol>
      • summary(null)
      • recommendation<p> Kindly address the preliminary queries raised.</p>
      • notified0
      • accepted(null)
      • conflict(null)
      • statusUnsubmitted
      • created2025-09-08 13:05:08
      • modified2025-09-08 13:05:08
    • 5(array)
      • id4178
      • user_id551
      • application_id1551
      • typereviewer_comment
      • assessment_typeclinical
      • title(null)
      • text(null)
      • summaryInclusion criteria comments The study anticipates to enrol participants with diverse medical conditions, but also participants with significant medical conditions will be excluded as per investigators judgement; therefore, are there exclusionary condtions? Study plan and design comments There is no 'risk/benefits' section in the protocol. Kindly clarify. 1.5.1 REQUESTS FOR ADDITIONAL INFORMATION 1. The study anticipates to enroll participants with diverse medical conditions, but also participants with significant medical conditions will be excluded as per investigators judgement; therefore, are there exclusionary conditions? 2. To include study risks.
      • recommendation(null)
      • notified0
      • accepted(null)
      • conflict(null)
      • statusSubmitted
      • created2025-09-11 09:03:48
      • modified2025-09-11 09:14:02
    • 6(array)
      • id4192
      • user_id846
      • application_id1551
      • typeppb_comment
      • assessment_type(null)
      • title(null)
      • text<ol> <li> <span style="font-size:14px;"><span style="font-family:bookman old style,serif;"><span style="caret-color: rgb(102, 102, 102);">The study anticipates to enroll participants with diverse medical conditions, but also participants with significant medical conditions will be excluded as per investigators judgement; therefore, are there exclusionary conditions? Kindly specify</span></span></span></li> <li> <span style="font-size:14px;"><span style="font-family:bookman old style,serif;"><span style="caret-color: rgb(102, 102, 102);">Kindly include study risks.</span></span></span></li> </ol>
      • summary(null)
      • recommendation<p> Kindly address additional rqueries raised.</p>
      • notified0
      • accepted(null)
      • conflict(null)
      • statusUnsubmitted
      • created2025-09-29 10:36:01
      • modified2025-09-29 10:36:01
    • 7(array)
      • id4235
      • user_id846
      • application_id1551
      • typeppb_comment
      • assessment_type(null)
      • title(null)
      • text<ol> <li> <b style="color: rgb(0, 0, 0); font-family: "Times New Roman";">.</b><span style="color: rgb(0, 0, 0); font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"><b> </b></span><b style="color: rgb(0, 0, 0); font-family: "Times New Roman";">Study Objectives</b></li> </ol> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> <i>“We hereby submit for your review the above protocol which aims to advance the accuracy </i><i>and reliability of the Binah.ai algorithm in the Kenyan population “(Abstract, page 11).</i></p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> <span style="font-stretch: normal; line-height: normal; font-family: Helvetica; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"></span><span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>What is the exact objective of the study, to validate binah.ai, which has not been approved by FDA since submission in 2022 (as per literature), to gather more data to</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> support its approval, or is it a proof of concept?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> <span style="font-stretch: normal; line-height: normal; font-family: Helvetica; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"></span><span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>The binah.ai website appears to suggest/indicate that the system is more of a commercial venture as per the statement:<i> “Support For Your Business’s Needs”</i> [1].</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> a)<span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>Are there publications to prove the efficacy of this algorithm?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> b)<span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>If not, what supports its use in humans including its use in some risky procedures described in 3 below?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> c)<span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>What is the justification of using the unproved system in Kenyan patients?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> <b>2.</b><span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"><b> </b></span><b>Protocol</b></p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> <span style="font-stretch: normal; line-height: normal; font-family: Helvetica; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"></span><span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>In as much as the study will be carried globally in five countries and on over 20,000 participants (page 11), the presented protocol, including the references appears to indicate that it is purely a Kenyan protocol (i.e. a Kenyan site addendum).</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> a)<span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>The investigators should provide a copy of the universal (main) protocol that would provide consistency of the study and results?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> b)<span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>Who is the overall PI for this study across the five countries?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> c)Is the study designed to be carried differently across the five countries?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> d)If so, why the lack of uniformity?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> e)Will some of the procedures that may not necessarily be accepted in US and Europe be carried out in Kenya?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> <b>3.</b><span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"><b> </b></span><b>Study Procedures</b></p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> a)<span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>Some of the procedures appear to be dangerous, such as temporarily withholding oxygen supplementation from a participant in order for the <i>“By face” </i>experiment</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> described on page 26.</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> b)<span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>Patients on oxygen supplementation are very sick patients who continuously require oxygen. What happens if the participant undergoes respiratory distress and coma</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> resulting from this action?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> c)<span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>Are the researcher’s medical officers who are well trained to manage any complications resulting from this action?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> d)<span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>Does this meet ethical considerations?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> e)Is this kind of procedure acceptable in US and Europe, or Japan? <i>Or</i> is it only carried out in Kenya, but not in all the five countries?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> f)<span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>Could this be part of the reasons why the study lacks a universal Protocol?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> <b>4.</b><span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"><b> </b></span><b>Interventions</b></p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> <span style="font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;">1</span>a)<span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>What happens to patients who are found out/diagnosed to have some life threating conditions, such as severe blood pressure, diabetes and other life threatening events?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> b)<span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>Will any interventions be carried out post diagnosis?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> c)<span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>Where will the patients be managed, and at whose cost?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> <b>5.</b><span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"><b> </b></span><b>Exploratory Endpoint (page 21)</b></p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> a)<span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>The objectives of the exploratory tests using the patients’ blood described in page 21 should be clarified</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> b)<span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>What kind of tests will be carried out?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> c)Will it involve genetic tests?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> d)Will the tests be done locally, at the site, or with blood samples/products be shipped out of the country?</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> <b>6.</b><span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"><b> </b></span><b>Triage/consenting process (page 34)</b></p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> <span style="font-stretch: normal; line-height: normal; font-family: Helvetica; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"></span><span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>How will the consenting process be carried out so as to inform the participant on all the desired tests and potential benefits</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> <span style="font-stretch: normal; line-height: normal; font-family: Helvetica; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"></span><span style="font-stretch: normal; line-height: normal; font-family: Arial; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal;"> </span>The Consent forms have not been provided in the current protocol. They should be provided.</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> <b>References</b></p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> 1. Binah.ai, Health Checks Anywherewe: The #1 AI-Powered Health and Wellness Check</p> <p style="margin: 0px; font-stretch: normal; line-height: normal; font-family: "Times New Roman"; font-size-adjust: none; font-kerning: auto; font-variant-alternates: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-position: normal; font-feature-settings: normal; font-optical-sizing: auto; font-variation-settings: normal; color: rgb(0, 0, 0);"> Software, Available at: <span style="color: #0b4cb4">https://www.binah.ai/</span></p>
      • summary(null)
      • recommendation<p> <span style="color:#000000;"><span style="font-size:14px;"><span style="font-family:bookman old style,serif;">Kindly address the comments raised</span></span></span></p>
      • notified0
      • accepted(null)
      • conflict(null)
      • statusUnsubmitted
      • created2025-10-13 11:02:55
      • modified2025-10-13 11:02:55
  • Acceptance(empty)
  • Amendment(empty)
  • InvestigatorContact(array)
    • 0(array)
      • id1290
      • application_id1551
      • given_nameBorna
      • middle_nameAchieng
      • family_nameNyaoke
      • qualificationMBChB, MPH
      • professional_address132 Manyani East Road, Nairobi, Kenya
      • telephone0756551551
      • emailborna@zuri.health
      • created2025-05-22 01:29:28
      • modified2025-07-11 11:33:04
  • ApplicationStage(array)
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      • application_id1551
      • stageScreening
      • start_date2025-06-19
      • statusComplete
      • commentManager first comment
      • end_date2025-06-25
      • created2025-06-19 18:46:53
      • modified2025-06-19 18:46:53
    • 1(array)
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      • start_date2025-06-25
      • statusComplete
      • commentManager assign reviewer
      • end_date2025-07-30
      • created2025-06-25 12:28:53
      • modified2025-06-25 12:28:53
    • 2(array)
      • id4427
      • application_id1551
      • stageUnsubmitted
      • start_date2025-07-11
      • statusComplete
      • commentPrincipal Investigator Re Submission
      • end_date2025-07-11
      • created2025-07-11 10:08:05
      • modified2025-07-11 10:08:05
    • 3(array)
      • id4454
      • application_id1551
      • stageAssign
      • start_date2025-07-30
      • statusComplete
      • commentReviewer accept
      • end_date2025-07-31
      • created2025-07-30 11:45:41
      • modified2025-07-30 11:45:41
    • 4(array)
      • id4455
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      • stageReview
      • start_date2025-07-31
      • statusComplete
      • commentManager review comment
      • end_date2025-09-08
      • created2025-07-31 08:45:13
      • modified2025-07-31 08:45:13
    • 5(array)
      • id4509
      • application_id1551
      • stageReviewSubmission
      • start_date2025-09-08
      • statusComplete
      • commentApplicant review response
      • end_date2025-10-26
      • created2025-09-08 13:05:08
      • modified2025-09-08 13:05:08
    • 6(array)
      • id4526
      • application_id1551
      • stageFinalDecision
      • start_date2025-09-18
      • statusComplete
      • comment2
      • end_date2025-11-21
      • created2025-09-18 10:36:52
      • modified2025-09-18 10:36:52
    • 7(array)
      • id4616
      • application_id1551
      • stageAnnualApproval
      • start_date2025-11-21
      • statusCurrent
      • commentManager letter approve
      • end_date2026-11-21
      • created2025-11-21 11:27:32
      • modified2025-11-21 11:27:32
  • Pharmacist(array)
    • 0(array)
      • id745
      • application_id1551
      • reg_no3716
      • given_nameFAITH KWAMBOKA RORI
      • premise_nameZuri Health Medical Center
      • qualificationPHARMACIST
      • professional_address132 Manyani East Road, Nairobi, Kenya
      • valid_year2025
      • mobile0702070127
      • telephone
      • emailfaithrori94@gmail.com
      • created2025-05-22 01:29:28
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  • EthicalCommittee(array)
    • 0(array)
      • id767
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      • ethical_committeeKenyatta National Hospital - University of Nairobi
      • submission_date19-12-2024
      • erc_numberP856/12/2024
      • initial_approval19-05-2025
      • created2025-05-22 01:29:28
      • modified2025-07-11 11:33:04
  • AnnualLetter(array)
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      • id1450
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      • approval_noPPB/ECCT/25/06/03/2025(245)
      • content<h3 style="text-align: center;"> <img height="86" src="https://lh7-us.googleusercontent.com/eOWVvo3AHW74GguHveDaqdgy3YwNZqOqOO0QtscRoV4hJfcvt8Q6v4oLN3beVNvClvoD1ncu1RhB5D4iuAY-5R9h1aD2lEGqUorBVcQ0azfxsdvIz-WhbF3rA9-VQomtusnP2bNZTuYLFTC6vQ46nQ" style="background-color: transparent; color: rgb(0, 0, 0); font-family: "Bookman Old Style", serif; font-size: 11pt; white-space-collapse: preserve; margin-left: 0px; margin-top: 0px;" width="116" /></h3> <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> </div> </td> </tr> </tbody> </table> <address> <span style="font-family: "bookman old style", serif;"><span style="font-size: 11px;"> </span></span></address> <address> <span style="font-family: "bookman old style", serif;">When replying please quote</span></address> <p> <span style="font-family:bookman old style,serif;"><strong>Ref.</strong> <strong>No.</strong> <strong>PPB/ECCT/25/06/03/2025(483)                                                                                                                                                       21st November 2025</strong></span></p> <p> <span style="font-family:bookman old style,serif;"><strong>Dr. Borna Achieng Nyaoke,</strong></span></p> <p> <span style="font-family:bookman old style,serif;"><strong>Principal</strong> <strong>Investigator</strong> <strong>ECCT/25/06/03,</strong></span></p> <p> <span style="font-family:bookman old style,serif;"><strong>132 Manyani East Road, </strong></span></p> <p> <span style="font-family:bookman old style,serif;"><strong>Nairobi, Kenya,</strong></span></p> <p>  </p> <p> <span style="font-family:bookman old style,serif;">Dear Sir/Madam,</span></p> <p> <span style="color:#000000;"><u><strong><span style="font-family:bookman old style,serif;">Re: ECCT/25/06/03 : Initial Approval; </span><span style="font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;">Physiological and Biomarker Monitoring: Enhancing Vital Signs and Biomarkers Algorithm of Binah.AI in the Kenyan Population (</span><strong style="font-family: "bookman old style", serif;">ZHR-001).</strong></strong></u></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. Evidence of recent GCP training of the core study staff<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/102356">gcp_certificate_dr_borna_nyaoke.pdf</a> dated 26th November 2024 Version 1<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/102357">gcp_certificate_dr_barbara.pdf</a> dated 2nd April 2025 Version 1<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/105652">faith_rori_gcp_cert_v1_0_20_june_2025.pdf</a> dated 20th June 2025 Version 1<br /> 2. 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="https://ctr.pharmacyboardkenya.org/attachments/download/102359">dr_barbara_tarno_cv.pdf</a> dated 14th May 2025 Version 1<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/104505">faith_rori_cv.pdf</a> dated 19th June 2025 Version 1<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/105651">dr_borna_nyaoke_cv_2025.pdf</a> dated 3rd July 2025 Version 1<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/105664">pi_workload_19_june_2025.pdf</a> dated 20th May 2025 Version 2<br /> 3. Patient Information leaflet and Informed consent form<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/102361">zhr_001_informed_consent_form_v2_0_20_march_2025_clean_english.pdf</a> dated 20th March 2025 Version 2<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/102362">zhr_001_informed_consent_form_v2_0_20_march_2025_clean_swahili.pdf</a> dated 20th May 2025 Version 2<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/105647">zhr_001_translation_certificate_v2_0_20mar2025_signed.pdf</a> dated 20th March 2025 Version 2<br /> 4. Indemnity cover for PI, investigators and study Pharmacist.<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/102363">professional_indemnity_certificate_dr_borna_nyaoke.pdf</a> dated 1st January 2025 Version 1<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/105657">dr_barbara_chebet_professional_indemnity_v1_0_11sep24.pdf</a> dated 11th September 2024 Version 1<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/105658">faith_kwamboka_rori_pi_certificate_v1_0_03_july_2025.pdf</a> dated 3rd July 2025 Version 1<br /> 5. Copy of favorable opinion letter from the local Ethics Review Committee (ERC).<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/102364">knh_uon_ethics_approval_19may2025.pdf</a> dated 19th May 2025 Version 1<br /> 6. Copy of current Practice Licenses for the Investigators and study Pharmacist<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/102365">borna_practice_licence_2025.pdf</a> dated 1st January 2025 Version 1<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/103757">dr_barbara_tarno_practice_licence_osp74069438.pdf</a> dated 14th May 2025 Version 1<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/104478">pharmacist_annual_practice_license.pdf</a> dated 23rd January 2025 Version 1<br /> 7. GMP certificate of the investigational product from the site of manufacture<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/103401">certificates_of_manufacture.pdf</a> dated 20th May 2025 Version 1<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/103402">3903038_iso_13485_2016_and_en_iso_13485_2016.pdf</a> dated 4th July 2022 Version 1<br /> 8. Certificate of Analysis of the investigational product<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/103403">med_000025_blood_pressure_accuracy_report_of_sdk_5_9_1_rev2_final.pdf</a> dated 17th March 2025 Version 2<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/103404">med_000026_pulse_rate_accuracy_report_of_sdk_5_9_1_final_rev2_final.pdf</a> dated 17th March 2025 Version 2<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/103405">med_000028_hrv_accuracy_report_of_sdk_5_9_1_rev2_final.pdf</a> dated 17th March 2025 Version 2<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/103406">med_000029_hb_accuracy_report_of_sdk_5_9_1_rev1_final.pdf</a> dated 17th March 2025 Version 1<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/103407">med_000030_hba1c_accuracy_report_of_sdk_5_9_1_rev1_final.pdf</a> dated 17th March 2025 Version 1<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/105665">technical_analytical_validation_v1_0_01_july_2025.pdf</a> dated 1st July 2025 Version 1<br /> 9. Investigational Medicinal Product Dossier (IMPD)<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/103409">impd_17.pdf</a> dated 20th May 2025 Version 1<br /> 10. Stability data of the investigational product<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/103410">stability_data_25.pdf</a> dated 20th May 2025 Version 1<br /> 11. Evidence of contractual agreement between sponsor and Principal Investigator.<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/103752">zuri_health_mou_binah_dec_04_v2_signed.pdf</a> dated 18th December 2024 Version 2<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/104468">pi_agreement_x_zuri_health.pdf</a> dated 14th May 2025 Version 1<br /> 12. Financial declaration by Sponsor and/or PI<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/103758">declaration_of_financial_disclosure_ppb.pdf</a> dated 4th June 2025 Version 1<br /> 13. DSMB Charter including the composition and meeting schedule<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/103761">dsmb_10.pdf</a> dated 4th June 2025 Version 1<br /> 14. Clinical Trials Insurance cover for study participants<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/104470">insurance_policy_4.pdf</a> dated 19th June 2025 Version 1<br /> 15. Payment of fees<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/104472">ppb_ecitizen_payment.pdf</a> dated 2nd April 2025 Version 1<br /> 16. Copy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/104475">israel_moh_approval_hebrew.pdf</a> dated 14th May 2025 Version 3<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/105654">sheba_medical_center_israel_approval_v1_0_31_jan_2021.pdf</a> dated 20th March 2025 Version 2<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/105655">salus_irb_usa_approval_v1_0_21_sept_2020.pdf</a> dated 14th May 2025 Version 1<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/105656">lmrc_ec_india_approval_v1_0_16may2023.pdf</a> dated 16th May 2023 Version 1<br /> 17. Adequate data and information from previous studies and Phases to support carrying out of the current study<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/104476">med_000025_blood_pressure_accuracy_report_of_sdk_5_9_1_rev2_final_2.pdf</a> dated 19th June 2025 Version 1<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/104477">med_000026_pulse_rate_accuracy_report_of_sdk_5_9_1_final_rev2_final_2.pdf</a> dated 19th June 2025 Version 1<br /> 18. The Study Protocol<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/105645">zhr_001_physiological_and_biomarkers_collection_study_protocol_v3_0_14_may_2025.pdf</a> dated 14th May 2025 Version 3<br /> 19. Registration of the study at Pan African Clinical Trials Registry https://pactr.samrc.ac.za<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/105646">pactr_trial_approval_letter_v1_0_04_june_25.pdf</a> dated 4th June 2025 Version 1.0<br /> 20. Investigators Brochure/Package inserts<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/105648">package_inserts_v3_0_15_april_24.pdf</a> dated 15th April 2025 Version 3<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/105649">working_instructions_for_recorder_app_version_3_0_15april2024.pdf</a> dated 15th April 2025 Version 3<br /> 21. Cover Letter (Should list all the submitted documents, their version numbers and dates)<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/105650">ppb_cover_letter_zhr_001_v1_0_19june2025.pdf</a> dated 19th June 2025 Version 1<br /> 22. Statistical Analysis Plan<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/105659">med_000038_statistical_analysis_plan_sap_version_1_0_03_july_25.pdf</a> dated 3rd July 2025 Version 1<br /> 23. 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="https://ctr.pharmacyboardkenya.org/attachments/download/105660">declaration_by_pi_19_june_2025.pdf</a> dated 19th July 2025 Version 1<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/105661">applicant_statement_2.pdf</a> dated 14th May 2025 Version 1<br /> 24. 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="https://ctr.pharmacyboardkenya.org/attachments/download/105662">declaration_by_pi_19_june_2025_2.pdf</a> dated 19th June 2025 Version 1<br /> 25. Signed Checklist<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/105663">checklist_30_june_2025.pdf</a> dated 2nd April 2025 Version 1<br /> 26. Detailed budget of the study<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/105666">zhr_001_budget_v1_0_09june2025.pdf</a> dated 9th June 2025 Version 1<br /> 27. Pictorial Sample of the investigational products. This sample should include the text of the labeling to be used<br /> <a href="https://ctr.pharmacyboardkenya.org/attachments/download/105667">pictorial_sample_of_the_medical_device_v1_0_09_june_25.pdf</a> dated 9th June 2025 Version 1</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 approval to the study <strong>ZHR-001</strong><strong>.</strong> <strong>(ECCT/25/06/03).</strong></span></p> <p> <span style="font-family: "bookman old style", serif;">This approval is </span><strong style="font-family: "bookman old style", serif;">valid</strong><span style="font-family: "bookman old style", serif;"> </span><strong style="font-family: "bookman old style", serif;">for</strong><span style="font-family: "bookman old style", serif;"> </span><strong style="font-family: "bookman old style", serif;">one</strong><span style="font-family: "bookman old style", serif;"> </span><strong style="font-family: "bookman old style", serif;">year</strong><span style="font-family: "bookman old style", serif;"> and in case the study extends beyond one year from the date of this letter, you are required to seek approval before proceeding with the study. The expiry date is 21st November 2026.</span></p> <ol> <li> <span style="font-family:bookman old style,serif;">All safety reports should be submitted to ECCT as per the current PPB clinical trials guidelines.</span></li> <li> <span style="font-family:bookman old style,serif;">Take note that 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-family:bookman old style,serif;">The Pharmacy and Poisons Board requires you to <strong>provide</strong> <strong>regular</strong> <strong>updates</strong> <strong>and Quarte</strong><strong>rly</strong> <strong>reports</strong>, especially on Suspected Unexpected Serious Adverse Reactions (SUSARS) from the study, for monitoring purposes and involve the PPB where necessary.</span></li> <li> <span style="font-family:bookman old style,serif;">You are also reminded that upon conclusion of the study, you shall be required to submit the executive summary report of the study <strong>within</strong> <strong>30</strong> <strong>d</strong><strong>ays</strong> while a copy of the clinical study report <strong>in</strong> <strong>ICH</strong> <strong>E3</strong> <strong>format</strong> should be submitted to us <strong>within</strong> <strong>180</strong> <strong>days</strong> of the study closure.</span></li> </ol> <p> <span style="font-family:bookman old style,serif;">Yours Sincerely,</span></p> <p> <img alt="" src="data:image/png;base64,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/></p> <p> <span style="font-family: "bookman old style", serif;">Dr. Samuel Kerama</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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      • modified2025-07-11 10:28:34
      • pathdoc/working_instructions_for_recorder_app_version_3_0_15april2024.pdf
    • 34(array)
      • id105650
      • modelChecklist
      • file/var/www/html/ctr/app/webroot/media/transfer/doc/ppb_cover_letter_zhr_001_v1_0_19june2025.pdf
      • foreign_key1551
      • dirnamedoc
      • basenameppb_cover_letter_zhr_001_v1_0_19june2025.pdf
      • checksum9925df9a04faf3c5ad7e771ed8808421
      • alternative(null)
      • groupapplicant_covering_letter
      • descriptionCover Letter (Should list all the submitted documents, their version numbers and dates) *
      • year(null)
      • file_date19-06-2025
      • pocket_nameapplicant_covering_letter
      • version_no1
      • created2025-07-11 10:29:22
      • modified2025-07-11 10:29:22
      • pathdoc/ppb_cover_letter_zhr_001_v1_0_19june2025.pdf
    • 35(array)
      • id105651
      • modelChecklist
      • file/var/www/html/ctr/app/webroot/media/transfer/doc/dr_borna_nyaoke_cv_2025.pdf
      • foreign_key1551
      • dirnamedoc
      • basenamedr_borna_nyaoke_cv_2025.pdf
      • checksuma24c368d433638dcab8ae3f16ac8aae8
      • 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_date03-07-2025
      • pocket_nameapplicant_investigators_cv
      • version_no1
      • created2025-07-11 10:31:09
      • modified2025-07-11 10:31:09
      • pathdoc/dr_borna_nyaoke_cv_2025.pdf
    • 36(array)
      • id105652
      • modelChecklist
      • file/var/www/html/ctr/app/webroot/media/transfer/doc/faith_rori_gcp_cert_v1_0_20_june_2025.pdf
      • foreign_key1551
      • dirnamedoc
      • basenamefaith_rori_gcp_cert_v1_0_20_june_2025.pdf
      • checksum25d09df965c4c28cab7c641d9a687b2d
      • alternative(null)
      • groupapplicant_gcp_training
      • descriptionEvidence of recent GCP training of the core study staff *
      • year(null)
      • file_date20-06-2025
      • pocket_nameapplicant_gcp_training
      • version_no1
      • created2025-07-11 10:31:56
      • modified2025-07-11 10:31:56
      • pathdoc/faith_rori_gcp_cert_v1_0_20_june_2025.pdf
    • 37(array)
      • id105654
      • modelChecklist
      • file/var/www/html/ctr/app/webroot/media/transfer/doc/sheba_medical_center_israel_approval_v1_0_31_jan_2021.pdf
      • foreign_key1551
      • dirnamedoc
      • basenamesheba_medical_center_israel_approval_v1_0_31_jan_2021.pdf
      • checksumabac2109685c0bd77cdb68ae7e96973f
      • alternative(null)
      • groupapplicant_approval_letter
      • descriptionCopy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable
      • year(null)
      • file_date20-03-2025
      • pocket_nameapplicant_approval_letter
      • version_no2
      • created2025-07-11 10:36:56
      • modified2025-07-11 11:09:56
      • pathdoc/sheba_medical_center_israel_approval_v1_0_31_jan_2021.pdf
    • 38(array)
      • id105655
      • modelChecklist
      • file/var/www/html/ctr/app/webroot/media/transfer/doc/salus_irb_usa_approval_v1_0_21_sept_2020.pdf
      • foreign_key1551
      • dirnamedoc
      • basenamesalus_irb_usa_approval_v1_0_21_sept_2020.pdf
      • checksumb101539455248ab0a75a90d98d0fb075
      • alternative(null)
      • groupapplicant_approval_letter
      • descriptionCopy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable
      • year(null)
      • file_date14-05-2025
      • pocket_nameapplicant_approval_letter
      • version_no1
      • created2025-07-11 10:37:36
      • modified2025-07-11 11:09:56
      • pathdoc/salus_irb_usa_approval_v1_0_21_sept_2020.pdf
    • 39(array)
      • id105656
      • modelChecklist
      • file/var/www/html/ctr/app/webroot/media/transfer/doc/lmrc_ec_india_approval_v1_0_16may2023.pdf
      • foreign_key1551
      • dirnamedoc
      • basenamelmrc_ec_india_approval_v1_0_16may2023.pdf
      • checksum10245f0af8c01bfb98ffb25143c09aa8
      • alternative(null)
      • groupapplicant_approval_letter
      • descriptionCopy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable
      • year(null)
      • file_date16-05-2023
      • pocket_nameapplicant_approval_letter
      • version_no1
      • created2025-07-11 10:40:26
      • modified2025-07-11 10:40:26
      • pathdoc/lmrc_ec_india_approval_v1_0_16may2023.pdf
    • 40(array)
      • id105657
      • modelChecklist
      • file/var/www/html/ctr/app/webroot/media/transfer/doc/dr_barbara_chebet_professional_indemnity_v1_0_11sep24.pdf
      • foreign_key1551
      • dirnamedoc
      • basenamedr_barbara_chebet_professional_indemnity_v1_0_11sep24.pdf
      • checksum440c70bb7cb5122316b4539702a536f7
      • alternative(null)
      • groupapplicant_indemnity_pi
      • descriptionIndemnity cover for PI, investigators and study Pharmacist. *
      • year(null)
      • file_date11-09-2024
      • pocket_nameapplicant_indemnity_pi
      • version_no1
      • created2025-07-11 10:41:57
      • modified2025-07-11 10:41:57
      • pathdoc/dr_barbara_chebet_professional_indemnity_v1_0_11sep24.pdf
    • 41(array)
      • id105658
      • modelChecklist
      • file/var/www/html/ctr/app/webroot/media/transfer/doc/faith_kwamboka_rori_pi_certificate_v1_0_03_july_2025.pdf
      • foreign_key1551
      • dirnamedoc
      • basenamefaith_kwamboka_rori_pi_certificate_v1_0_03_july_2025.pdf
      • checksum4fe6352e730ec4ed4133a18b74442b9a
      • alternative(null)
      • groupapplicant_indemnity_pi
      • descriptionIndemnity cover for PI, investigators and study Pharmacist. *
      • year(null)
      • file_date03-07-2025
      • pocket_nameapplicant_indemnity_pi
      • version_no1
      • created2025-07-11 10:42:39
      • modified2025-07-11 10:42:39
      • pathdoc/faith_kwamboka_rori_pi_certificate_v1_0_03_july_2025.pdf
    • 42(array)
      • id105659
      • modelChecklist
      • file/var/www/html/ctr/app/webroot/media/transfer/doc/med_000038_statistical_analysis_plan_sap_version_1_0_03_july_25.pdf
      • foreign_key1551
      • dirnamedoc
      • basenamemed_000038_statistical_analysis_plan_sap_version_1_0_03_july_25.pdf
      • checksum7b578344fcecebdf3cd8314ff5d0afb1
      • alternative(null)
      • groupstatistical_analysis_plan
      • descriptionStatistical Analysis Plan *
      • year(null)
      • file_date03-07-2025
      • pocket_namestatistical_analysis_plan
      • version_no1
      • created2025-07-11 10:44:29
      • modified2025-07-11 10:44:29
      • pathdoc/med_000038_statistical_analysis_plan_sap_version_1_0_03_july_25.pdf
    • 43(array)
      • id105660
      • modelChecklist
      • file/var/www/html/ctr/app/webroot/media/transfer/doc/declaration_by_pi_19_june_2025.pdf
      • foreign_key1551
      • dirnamedoc
      • basenamedeclaration_by_pi_19_june_2025.pdf
      • checksumc06779b5de90fa04f1b8d151f987c981
      • alternative(null)
      • groupapplicant_statement
      • descriptionA signed statement by the applicant indicating that all information contained in, or referenced by, the application is complete and accurate and is not false or misleading. *
      • year(null)
      • file_date19-07-2025
      • pocket_nameapplicant_statement
      • version_no1
      • created2025-07-11 11:07:03
      • modified2025-07-11 11:07:03
      • pathdoc/declaration_by_pi_19_june_2025.pdf
    • 44(array)
      • id105661
      • modelChecklist
      • file/var/www/html/ctr/app/webroot/media/transfer/doc/applicant_statement_2.pdf
      • foreign_key1551
      • dirnamedoc
      • basenameapplicant_statement_2.pdf
      • checksum164c151b6f2aa2fe7f69cdf66670f07f
      • 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_date14-05-2025
      • pocket_nameapplicant_statement
      • version_no1
      • created2025-07-11 11:07:45
      • modified2025-07-11 11:09:56
      • pathdoc/applicant_statement_2.pdf
    • 45(array)
      • id105662
      • modelChecklist
      • file/var/www/html/ctr/app/webroot/media/transfer/doc/declaration_by_pi_19_june_2025_2.pdf
      • foreign_key1551
      • dirnamedoc
      • basenamedeclaration_by_pi_19_june_2025_2.pdf
      • checksumc06779b5de90fa04f1b8d151f987c981
      • 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_date19-06-2025
      • pocket_nameapplicant_signed_declaration
      • version_no1
      • created2025-07-11 11:08:55
      • modified2025-07-11 11:08:55
      • pathdoc/declaration_by_pi_19_june_2025_2.pdf
    • 46(array)
      • id105663
      • modelChecklist
      • file/var/www/html/ctr/app/webroot/media/transfer/doc/checklist_30_june_2025.pdf
      • foreign_key1551
      • dirnamedoc
      • basenamechecklist_30_june_2025.pdf
      • checksum83569b90a203d609b1ba8b9c93bff6ba
      • alternative(null)
      • groupapplicant_signed_checklist
      • descriptionSigned Checklist *
      • year(null)
      • file_date02-04-2025
      • pocket_nameapplicant_signed_checklist
      • version_no1
      • created2025-07-11 11:09:37
      • modified2025-07-11 11:09:56
      • pathdoc/checklist_30_june_2025.pdf
    • 47(array)
      • id105664
      • modelChecklist
      • file/var/www/html/ctr/app/webroot/media/transfer/doc/pi_workload_19_june_2025.pdf
      • foreign_key1551
      • dirnamedoc
      • basenamepi_workload_19_june_2025.pdf
      • checksum9a0555d5effb16a0bbd0630e04829c85
      • 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_date20-05-2025
      • pocket_nameapplicant_investigators_cv
      • version_no2
      • created2025-07-11 11:11:04
      • modified2025-07-11 11:20:57
      • pathdoc/pi_workload_19_june_2025.pdf
    • 48(array)
      • id105665
      • modelChecklist
      • file/var/www/html/ctr/app/webroot/media/transfer/doc/technical_analytical_validation_v1_0_01_july_2025.pdf
      • foreign_key1551
      • dirnamedoc
      • basenametechnical_analytical_validation_v1_0_01_july_2025.pdf
      • checksumc3ce57e2f5578a68185b5cd6584f7a55
      • alternative(null)
      • groupapplicant_analysis_cert
      • descriptionCertificate of Analysis of the investigational product *
      • year(null)
      • file_date01-07-2025
      • pocket_nameapplicant_analysis_cert
      • version_no1
      • created2025-07-11 11:14:32
      • modified2025-07-11 11:20:57
      • pathdoc/technical_analytical_validation_v1_0_01_july_2025.pdf
    • 49(array)
      • id105666
      • modelChecklist
      • file/var/www/html/ctr/app/webroot/media/transfer/doc/zhr_001_budget_v1_0_09june2025.pdf
      • foreign_key1551
      • dirnamedoc
      • basenamezhr_001_budget_v1_0_09june2025.pdf
      • checksumf4e46b3e156df7c3e9cec158d2e55cc9
      • alternative(null)
      • groupapplicant_detailed_budget
      • descriptionDetailed budget of the study *
      • year(null)
      • file_date09-06-2025
      • pocket_nameapplicant_detailed_budget
      • version_no1
      • created2025-07-11 11:19:38
      • modified2025-07-11 11:19:38
      • pathdoc/zhr_001_budget_v1_0_09june2025.pdf
    • 50(array)
      • id105667
      • modelChecklist
      • file/var/www/html/ctr/app/webroot/media/transfer/doc/pictorial_sample_of_the_medical_device_v1_0_09_june_25.pdf
      • foreign_key1551
      • dirnamedoc
      • basenamepictorial_sample_of_the_medical_device_v1_0_09_june_25.pdf
      • checksum595e1a7297a248de23eceae27f3d5d6b
      • 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_date09-06-2025
      • pocket_nameapplicant_pictorial_sample
      • version_no1
      • created2025-07-11 11:31:54
      • modified2025-07-11 11:31:54
      • pathdoc/pictorial_sample_of_the_medical_device_v1_0_09_june_25.pdf
  • StudyMonitor(empty)
  • ProtocolOutsource(empty)
  • Outsource(empty)
• redir
• $request->data(empty)
• $this->validationErrors(array)
  • Permission(empty)
  • Aro(empty)
  • Aco(empty)
  • Application(empty)
  • User(empty)
  • TrialStatus(empty)
  • Review(empty)
  • ActiveInspector(empty)
  • ManagerReview(empty)
  • Acceptance(empty)
  • Amendment(empty)
  • InvestigatorContact(empty)
  • ApplicationStage(empty)
  • Pharmacist(empty)
  • EthicalCommittee(empty)
  • AnnualLetter(empty)
  • AmendmentLetter(empty)
  • AmendmentApproval(empty)
  • AmendmentApprovalSummary(empty)
  • Organization(empty)
  • SiteDetail(empty)
  • Placebo(empty)
  • Sponsor(empty)
  • SiteInspection(empty)
  • Sae(empty)
  • Ciom(empty)
  • StudyRoute(empty)
  • Manufacturer(empty)
  • Reassignment(empty)
  • Attachment(empty)
  • AnnualApproval(empty)
  • AmendmentChecklist(empty)
  • Reminder(empty)
  • ParticipantFlow(empty)
  • Budget(empty)
  • Deviation(empty)
  • Document(empty)
  • CoverLetter(empty)
  • Protocol(empty)
  • PatientLeaflet(empty)
  • Brochure(empty)
  • GmpCertificate(empty)
  • Cv(empty)
  • Finance(empty)
  • Declaration(empty)
  • IndemnityCover(empty)
  • OpinionLetter(empty)
  • ApprovalLetter(empty)
  • Statement(empty)
  • ParticipatingStudy(empty)
  • Addendum(empty)
  • Registration(empty)
  • Fee(empty)
  • Checklist(empty)
  • StudyMonitor(empty)
  • ProtocolOutsource(empty)
  • Outsource(empty)
• Loaded Helpers(array)
  • 0Html
  • 1Form
  • 2Session
  • 3Text
  • 4Number
  • 5SimpleGraph
  • 6DebugTimer
  • 7Toolbar
  • 8HtmlToolbar

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

• 0/var/www/html/ctr/app/Plugin/Media/Lib/mm/src
• 1/var/www/html/ctr/lib
• 3/usr/share/php
• 4-> /var/www/html/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)
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    • 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