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  • trial_therapeutic_exploratory1
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• trial_statuses(array)
  • 1Recruiting
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  • 8Writing-up
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  • 12Ongoing Closeout Phase
• applications(array)
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    • Application(array)
      • id86
      • user_id26
      • application_id(null)
      • is_child0
      • trial_status_id(null)
      • total_sites4
      • abstract_of_study<p>\n Background</p>\n<div class=\"flex flex-grow flex-col max-w-full\">\n <div class=\"min-h-[20px] text-message flex flex-col items-start whitespace-pre-wrap break-words [.text-message+&]:mt-5 juice:w-full juice:items-end overflow-x-auto gap-2\" data-message-author-role=\"assistant\" data-message-id=\"6bad6573-5683-44dc-898f-edbdad90c62b\" dir=\"auto\">\n <div class=\"flex w-full flex-col gap-1 juice:empty:hidden juice:first:pt-[3px]\">\n <div class=\"markdown prose w-full break-words dark:prose-invert dark\">\n <p>\n Cancer treatment efficacy varies significantly among patients, often due to genetic differences in tumor cells. Identifying genetic markers that predict treatment response can enhance personalized medicine approaches, leading to improved outcomes and reduced adverse effects.</p>\n <h4>\n Objective</h4>\n <p>\n This study aims to investigate genetic markers that can predict the response to cancer treatments. By analyzing the genetic profiles of tumors from a diverse patient cohort, we seek to identify patterns associated with favorable or unfavorable treatment outcomes.</p>\n <h4>\n Methods</h4>\n <p>\n We will conduct a genome-wide association study (GWAS) using tumor samples from patients undergoing various cancer therapies. High-throughput sequencing technologies will be employed to identify genetic variants. Bioinformatics tools will analyze the correlation between these genetic variants and treatment responses, including chemotherapy, targeted therapy, and immunotherapy. Multivariate analysis will control for potential confounders such as age, sex, cancer type, and stage.</p>\n <h4>\n Results</h4>\n <p>\n Preliminary data suggest the presence of specific genetic markers associated with treatment efficacy and resistance. Identifying these markers will allow us to develop predictive models for clinical use.</p>\n <h4>\n Conclusion</h4>\n <p>\n Understanding genetic markers that predict cancer treatment response has the potential to revolutionize cancer care by facilitating personalized treatment plans. This study aims to contribute to the growing field of precision oncology, ultimately improving patient outcomes and quality of life.</p>\n <h4>\n Keywords</h4>\n <p>\n Cancer genomics, genetic markers, treatment response, personalized medicine, genome-wide association study, precision oncology.</p>\n </div>\n </div>\n </div>\n</div>\n<p>\n  </p>\n
      • study_title<p>\n Investigating Genetic Markers for Predicting Cancer Treatment Response</p>\n
      • laymans_summary<p>\n Cancer treatment can be highly effective for some patients but less so for others. This difference in treatment response often depends on unique genetic factors within each person's cancer cells. Our study aims to identify specific genetic markers that can predict how well a patient will respond to different cancer treatments.</p>\n<div class=\"flex flex-grow flex-col max-w-full\">\n <div class=\"min-h-[20px] text-message flex flex-col items-start whitespace-pre-wrap break-words [.text-message+&]:mt-5 juice:w-full juice:items-end overflow-x-auto gap-2\" data-message-author-role=\"assistant\" data-message-id=\"3a341212-4d02-48e4-a41c-b522ac742f4c\" dir=\"auto\">\n <div class=\"flex w-full flex-col gap-1 juice:empty:hidden juice:first:pt-[3px]\">\n <div class=\"markdown prose w-full break-words dark:prose-invert dark\">\n <p>\n By examining the DNA of cancer cells from a diverse group of patients, we hope to find patterns that indicate whether a particular treatment is likely to be successful. Understanding these genetic markers will help doctors choose the most effective therapy for each individual, leading to better outcomes and fewer side effects.</p>\n <p>\n Ultimately, our goal is to move towards more personalized cancer care, where treatments are tailored to the genetic makeup of each patient's cancer, improving the chances of successful treatment and recovery.</p>\n </div>\n </div>\n </div>\n</div>\n<p>\n  </p>\n
      • short_titleCancer Genomics
      • protocol_noECCT/24/06/02
      • reference_no(null)
      • version_no1.0
      • date_of_protocol11-06-2024
      • study_drugGenomirix
      • disease_conditionCancer
      • product_type_biologicals1
      • product_type_proteins1
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device1
      • product_type_chemical_name4-(2-(4-Methylpiperazin-1-yl)ethyl)-N-(4-(trifluoromethyl)phenyl)pyridine-2-carboxamide
      • product_type_medical_device_nameGeneMark Analyzer
      • comparatorYes
      • comparator_nameOncoraGen
      • comparator_registeredYes
      • comparator_countriesUnited States\nCanada\nUnited Kingdom\nGermany\nFrance\nJapan\nAustralia\nSouth Korea\nBrazil\n
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjayoma@intellisoftkenya.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantJavan Ayoma
      • declaration_date111-06-2024
      • declaration_principal_investigatorECR
      • declaration_date211-06-2024
      • placebo_presentNo
      • study_objectives<ol>\n <li>\n To evaluate the safety and efficacy of a new medication in reducing blood pressure in patients with hypertension.</li>\n <li>\n To compare the effectiveness of two different treatment regimens for managing symptoms of depression in adults.</li>\n <li>\n To assess the long-term outcomes of a surgical procedure for patients with advanced stage cancer.</li>\n <li>\n To investigate the impact of a lifestyle intervention program on weight loss and cardiovascular health in overweight individuals.</li>\n <li>\n To determine the optimal dosage of a novel drug in treating acute pain following surgery.</li>\n <li>\n To examine the effects of a dietary supplement on cognitive function in older adults with mild cognitive impairment.</li>\n <li>\n To explore the feasibility of a telemedicine intervention in improving access to mental health services for rural populations.</li>\n <li>\n To investigate the efficacy of a behavioral therapy in reducing symptoms of anxiety disorders in adolescents.</li>\n <li>\n To assess the safety and tolerability of a new vaccine candidate in preventing infections in children.</li>\n <li>\n To evaluate the impact of a physical activity intervention on quality of life and functional outcomes in patients with chronic pain conditions.</li>\n</ol>\n
      • principal_inclusion_criteria<ol>\n <li>\n Age between 18 and 65 years.</li>\n <li>\n Diagnosis of type 2 diabetes mellitus.</li>\n <li>\n Body mass index (BMI) between 25 and 40 kg/m^2.</li>\n <li>\n Histologically confirmed diagnosis of breast cancer.</li>\n <li>\n Presence of moderate to severe symptoms of depression as assessed by a standardized questionnaire.</li>\n <li>\n Documented history of hypertension with systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg.</li>\n <li>\n Diagnosis of Alzheimer's disease according to established clinical criteria.</li>\n <li>\n Previously untreated stage III non-small cell lung cancer.</li>\n <li>\n Willingness to comply with study procedures and follow-up visits.</li>\n <li>\n Written informed consent provided by the participant or legally authorized representative.</li>\n</ol>\n
      • principal_exclusion_criteria<ul>\n <li>\n Known allergy or hypersensitivity to the investigational drug or any of its components.</li>\n <li>\n History of significant cardiovascular disease, including myocardial infarction or stroke within the past 6 months.</li>\n <li>\n Presence of a severe psychiatric disorder that could affect the participant's ability to comply with study procedures.</li>\n <li>\n Use of concomitant medications that are contraindicated with the investigational drug.</li>\n <li>\n Pregnancy or breastfeeding.</li>\n <li>\n Active substance abuse or dependence within the past 12 months.</li>\n <li>\n Participation in another clinical trial within the past 30 days.</li>\n <li>\n Known history of human immunodeficiency virus (HIV) infection or hepatitis B or C.</li>\n <li>\n Uncontrolled hypertension, defined as systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg.</li>\n <li>\n Significant renal or hepatic impairment as determined by laboratory tests.</li>\n</ul>\n
      • primary_end_points<ol>\n <li>\n Change in mean systolic blood pressure from baseline to week 12.</li>\n <li>\n Percentage change in tumor size as assessed by imaging studies after 6 months of treatment.</li>\n <li>\n Time to recurrence of depressive symptoms as measured by a standardized depression rating scale.</li>\n <li>\n Overall survival at 2 years post-randomization.</li>\n <li>\n Proportion of participants achieving glycemic control (HbA1c < 7%) after 6 months of treatment.</li>\n <li>\n Improvement in cognitive function as measured by a validated cognitive assessment tool at week 24.</li>\n <li>\n Rate of adverse events leading to treatment discontinuation within the first 3 months of therapy.</li>\n <li>\n Change in mean pain intensity scores from baseline to week 8 as assessed by a visual analog scale.</li>\n <li>\n Proportion of participants achieving a 50% reduction in seizure frequency compared to baseline after 12 weeks of treatment.</li>\n <li>\n Change in mean forced expiratory volume in 1 second (FEV1) from baseline to week 26 in patients with chronic obstructive pulmonary disease (COPD).</li>\n</ol>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic1
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans1
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<div class=\"flex-1 overflow-hidden\">\n <div class=\"react-scroll-to-bottom--css-wpwpj-79elbk h-full\">\n <div class=\"react-scroll-to-bottom--css-wpwpj-1n7m0yu\">\n <div class=\"flex flex-col text-sm\">\n <div class=\"w-full text-token-text-primary\" data-scroll-anchor=\"true\" data-testid=\"conversation-turn-35\" dir=\"auto\">\n <div class=\"py-2 juice:py-[18px] px-3 text-base md:px-4 m-auto md:px-5 lg:px-1 xl:px-5\">\n <div class=\"mx-auto flex flex-1 gap-3 text-base juice:gap-4 juice:md:gap-5 juice:lg:gap-6 md:max-w-3xl lg:max-w-[40rem] xl:max-w-[48rem]\">\n <div class=\"group/conversation-turn relative flex w-full min-w-0 flex-col agent-turn\">\n <div class=\"flex-col gap-1 md:gap-3\">\n <div class=\"flex flex-grow flex-col max-w-full\">\n <div class=\"min-h-[20px] text-message flex flex-col items-start whitespace-pre-wrap break-words [.text-message+&]:mt-5 juice:w-full juice:items-end overflow-x-auto gap-2\" data-message-author-role=\"assistant\" data-message-id=\"99efe10e-e141-4373-acd9-b177540b4a00\" dir=\"auto\">\n <div class=\"flex w-full flex-col gap-1 juice:empty:hidden juice:first:pt-[3px]\">\n <div class=\"markdown prose w-full break-words dark:prose-invert dark\">\n <h3>\n Site 1: Afya Medical Center</h3>\n <ul>\n <li>\n <strong>Capacity of Site:</strong>\n <ul>\n <li>\n Outpatient Clinic: 20 patients per hour</li>\n <li>\n Inpatient Beds: 50 beds</li>\n </ul>\n </li>\n <li>\n <strong>Number of Staff:</strong> 30\n <ul>\n <li>\n Dr. Esther Mwangi - Medical Director - MD, MPH, 10 years of experience</li>\n <li>\n Nurse Jane Wanjiku - Head Nurse - BScN, 7 years of experience</li>\n <li>\n Pharmacist David Kimani - PharmD, 5 years of experience</li>\n <li>\n Lab Technician Mary Achieng - BSc in Medical Laboratory Science, 3 years of experience</li>\n <li>\n Study Coordinator Grace Njeri - BSc in Clinical Research, 2 years of experience</li>\n </ul>\n </li>\n <li>\n <strong>Facilities:</strong> Fully equipped outpatient clinic, laboratory, pharmacy, inpatient wards, emergency room</li>\n <li>\n <strong>Emergency Facilities:</strong> Fully equipped emergency room with resuscitation equipment and trained staff</li>\n <li>\n <strong>Other Relevant Infrastructure:</strong> Dedicated research wing for clinical trials, including separate study rooms and monitoring facilities.</li>\n </ul>\n <h3>\n Site 2: Upendo Hospital</h3>\n <ul>\n <li>\n <strong>Capacity of Site:</strong>\n <ul>\n <li>\n Outpatient Clinic: 25 patients per hour</li>\n <li>\n Inpatient Beds: 70 beds</li>\n </ul>\n </li>\n <li>\n <strong>Number of Staff:</strong> 40\n <ul>\n <li>\n Dr. Kevin Maina - Medical Director - MBChB, MPH, 12 years of experience</li>\n <li>\n Nurse Sarah Kinya - Head Nurse - BScN, 8 years of experience</li>\n <li>\n Pharmacist James Ogutu - PharmD, 6 years of experience</li>\n <li>\n Lab Technician Mercy Wangari - BSc in Medical Laboratory Science, 4 years of experience</li>\n <li>\n Study Coordinator Peter Kamau - BSc in Clinical Research, 3 years of experience</li>\n </ul>\n </li>\n <li>\n <strong>Facilities:</strong> Comprehensive outpatient and inpatient facilities, including surgery theaters, radiology department, pharmacy, laboratory.</li>\n <li>\n <strong>Emergency Facilities:</strong> Dedicated emergency department with trauma center and intensive care unit.</li>\n <li>\n <strong>Other Relevant Infrastructure:</strong> On-site research department with dedicated study rooms and conference facilities.</li>\n </ul>\n <h3>\n Site 3: Tumaini Medical Center</h3>\n <ul>\n <li>\n <strong>Capacity of Site:</strong>\n <ul>\n <li>\n Outpatient Clinic: 30 patients per hour</li>\n <li>\n Inpatient Beds: 60 beds</li>\n </ul>\n </li>\n <li>\n <strong>Number of Staff:</strong> 35\n <ul>\n <li>\n Dr. Faith Njoroge - Medical Director - MBChB, MPH, 11 years of experience</li>\n <li>\n Nurse Peter Otieno - Head Nurse - BScN, 9 years of experience</li>\n <li>\n Pharmacist Grace Wambui - PharmD, 7 years of experience</li>\n <li>\n Lab Technician John Mwangi - BSc in Medical Laboratory Science, 5 years of experience</li>\n <li>\n Study Coordinator Susan Auma - BSc in Clinical Research, 4 years of experience</li>\n </ul>\n </li>\n <li>\n <strong>Facilities:</strong> Modern outpatient department, fully equipped laboratory, pharmacy, comfortable inpatient wards.</li>\n <li>\n <strong>Emergency Facilities:</strong> Well-equipped emergency room with 24/7 availability.</li>\n <li>\n <strong>Other Relevant Infrastructure:</strong> Dedicated research wing with state-of-the-art equipment for clinical trials and data collection.</li>\n </ul>\n <h3>\n Site 4: Salama Clinic</h3>\n <ul>\n <li>\n <strong>Capacity of Site:</strong>\n <ul>\n <li>\n Outpatient Clinic: 15 patients per hour</li>\n <li>\n Inpatient Beds: 40 beds</li>\n </ul>\n </li>\n <li>\n <strong>Number of Staff:</strong> 25\n <ul>\n <li>\n Dr. Grace Nyambura - Medical Director - MBChB, MPH, 9 years of experience</li>\n <li>\n Nurse David Gitau - Head Nurse - BScN, 6 years of experience</li>\n <li>\n Pharmacist Mary Njeri - PharmD, 4 years of experience</li>\n <li>\n Lab Technician Mercy Chepkoech - BSc in Medical Laboratory Science, 3 years of experience</li>\n <li>\n Study Coordinator Paul Ochieng - BSc in Clinical Research, 2 years of experience</li>\n </ul>\n </li>\n <li>\n <strong>Facilities:</strong> Well-equipped outpatient department, pharmacy, laboratory, and comfortable inpatient wards.</li>\n <li>\n <strong>Emergency Facilities:</strong> Dedicated emergency room with basic resuscitation equipment and trained staff.</li>\n <li>\n <strong>Other Relevant Infrastructure:</strong> Limited research facilities, but capable of conducting basic clinical research and data collection.</li>\n </ul>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n</div>\n<p>\n  </p>\n
      • other_details_explanation<ul>\n <li>\n <p>\n <strong>Population Diversity:</strong> Kenya offers a diverse population with varying genetic backgrounds and lifestyles, which may provide valuable insights into the generalizability of study findings across different populations.</p>\n </li>\n <li>\n <p>\n <strong>Access to Patients:</strong> Kenya may have a higher prevalence of the target disease or condition, providing easier access to eligible participants for the clinical trial.</p>\n </li>\n <li>\n <p>\n <strong>Infrastructure and Expertise:</strong> Kenya has established research institutions, hospitals, and clinics with experienced healthcare professionals and researchers capable of conducting high-quality clinical trials.</p>\n </li>\n <li>\n <p>\n <strong>Regulatory Environment:</strong> Kenya's regulatory framework for clinical trials may be favorable or offer expedited approval processes, making it an attractive location for conducting research.</p>\n </li>\n <li>\n <p>\n <strong>Ethical Considerations:</strong> Kenya may have specific ethical guidelines or cultural considerations that align with the study objectives, ensuring that research is conducted in an ethical and culturally sensitive manner.</p>\n </li>\n <li>\n <p>\n <strong>Cost Considerations:</strong> Conducting clinical trials in Kenya may be more cost-effective compared to the host country, due to lower operational costs and potentially faster recruitment timelines.</p>\n </li>\n</ul>\n
      • other_details_regulatory_notapproved<ol>\n <li>\n <p>\n <strong>Kenyan Pharmacy and Poisons Board (PPB)</strong></p>\n <ul>\n <li>\n Date of Application: March 15, 2024</li>\n </ul>\n </li>\n <li>\n <p>\n <strong>South African Health Products Regulatory Authority (SAHPRA)</strong></p>\n <ul>\n <li>\n Date of Application: April 10, 2024</li>\n </ul>\n </li>\n <li>\n <p>\n <strong>Uganda National Drug Authority (NDA)</strong></p>\n <ul>\n <li>\n Date of Application: May 5, 2024</li>\n </ul>\n </li>\n <li>\n <p>\n <strong>Tanzania Medicines and Medical Devices Authority (TMDA)</strong></p>\n <ul>\n <li>\n Date of Application: June 1, 2024</li>\n </ul>\n </li>\n <li>\n <p>\n <strong>Nigerian National Agency for Food and Drug Administration and Control (NAFDAC)</strong></p>\n <ul>\n <li>\n Date of Application: July 3, 2024</li>\n </ul>\n </li>\n</ol>\n
      • other_details_regulatory_approved<ul>\n <li>\n <p>\n <strong>United States Food and Drug Administration (FDA)</strong></p>\n <ul>\n <li>\n Date of Approval: January 20, 2024</li>\n <li>\n Number of Sites:\n <ul>\n <li>\n United States: 10 sites</li>\n </ul>\n </li>\n </ul>\n </li>\n <li>\n <p>\n <strong>European Medicines Agency (EMA)</strong></p>\n <ul>\n <li>\n Date of Approval: February 5, 2024</li>\n <li>\n Number of Sites:\n <ul>\n <li>\n United Kingdom: 5 sites</li>\n <li>\n Germany: 3 sites</li>\n <li>\n France: 2 sites</li>\n </ul>\n </li>\n </ul>\n </li>\n <li>\n <p>\n <strong>Canadian Health Products and Food Branch (HPFB)</strong></p>\n <ul>\n <li>\n Date of Approval: March 1, 2024</li>\n <li>\n Number of Sites:\n <ul>\n <li>\n Canada: 4 sites</li>\n </ul>\n </li>\n </ul>\n </li>\n <li>\n <p>\n <strong>Australian Therapeutic Goods Administration (TGA)</strong></p>\n <ul>\n <li>\n Date of Approval: March 15, 2024</li>\n <li>\n Number of Sites:\n <ul>\n <li>\n Australia: 3 sites</li>\n </ul>\n </li>\n </ul>\n </li>\n <li>\n <p>\n <strong>Brazilian Health Regulatory Agency (ANVISA)</strong></p>\n <ul>\n <li>\n Date of Approval: April 10, 2024</li>\n <li>\n Number of Sites:\n <ul>\n <li>\n Brazil: 2 sites</li>\n </ul>\n </li>\n </ul>\n </li>\n</ul>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration18 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_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states4
      • number_of_sites4
      • multi_country_listChina\nIndia\nBraizil\nRussia \nUSA
      • data_monitoring_committeeYes
      • total_enrolment_per_site22500
      • total_participants_worldwide30000000
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenYes
      • subjects_nursing_womenYes
      • subjects_emergency_situationYes
      • subjects_incapable_consentYes
      • subjects_specifychildren aged 13-17years
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDr. Jane
      • investigator1_middle_name
      • investigator1_family_nameKamau
      • investigator1_qualificationMD, PhD
      • investigator1_professional_addressKenya Medical Research Institute (KEMRI) Clinical Research Center 123 Research Avenue Nairobi, Kenya
      • investigator1_telephone+254 123 456 789
      • investigator1_emailjkamau@kemri.go.ke
      • organisations_transferred_No
      • number_participants45000
      • notification<p>\n N/A</p>\n
      • approval_date21-06-2024
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted11-06-2024
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasontest
      • approved_date(null)
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • ecitizen_invoice304493
      • modified2024-06-21 06:55:17
      • created2024-06-11 03:54:24
      • ai_content(null)
    • InvestigatorContact(array)
      • 0(array)
        • id41
        • application_id86
        • given_nameJavan
        • middle_name
        • family_nameAyoma
        • qualificationMasters
        • professional_addressMs Drive
        • telephone+254702674563
        • emailjayoma@intellisoftkenya.com
        • investigator_roleprincipal
        • created2024-06-11 03:54:24
        • modified2024-06-11 09:01:24
    • SiteDetail(array)
      • 0(array)
        • id1670
        • application_id86
        • county_id47
        • site_name Afya Medical Center
        • physical_address123 Daktari Road, Nairobi, Kenya
        • contact_detailsTelephone Number: +254 701 234 567 P.O. Box: 10100-12345, Nairobi, Kenya
        • contact_person Dr. Esther Mwangi
        • site_capacity(null)
        • misc(null)
        • created2024-06-11 04:05:15
        • modified2024-06-11 09:01:24
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id1671
        • application_id86
        • county_id1
        • site_nameUpendo Hospital
        • physical_address456 Afya Street, Mombasa, Kenya
        • contact_detailsTelephone Number: +254 702 345 678 P.O. Box: 80100-45678, Mombasa, Kenya
        • contact_personMr. Kevin Maina
        • site_capacity(null)
        • misc(null)
        • created2024-06-11 04:26:59
        • modified2024-06-11 09:01:24
        • County(array)
          • id1
          • county_nameMombasa
          • created2012-05-31 16:15:11
          • modified2012-07-09 13:06:23
      • 2(array)
        • id1672
        • application_id86
        • county_id42
        • site_nameTumaini Medical Center
        • physical_address789 Matibabu Drive, Kisumu, Kenya
        • contact_detailsTelephone Number: +254 703 456 789 P.O. Box: 40100-78901, Kisumu, Kenya
        • contact_personDr. Faith Njoroge
        • site_capacity(null)
        • misc(null)
        • created2024-06-11 04:26:59
        • modified2024-06-11 09:01:24
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 3(array)
        • id1673
        • application_id86
        • county_id35
        • site_nameSalama Clinic
        • physical_address101 Jibu Avenue, Nakuru, Kenya
        • contact_detailsTelephone Number: +254 704 567 890 P.O. Box: 20100-10101, Nakuru, Kenya
        • contact_personMs. Grace Nyambura
        • site_capacity(null)
        • misc(null)
        • created2024-06-11 04:26:59
        • modified2024-06-11 09:01:24
        • County(array)
          • id35
          • county_nameKericho
          • created2012-06-15 10:26:16
          • modified2012-06-15 10:26:16
    • Sponsor(array)
      • 0(array)
        • id18
        • application_id86
        • sponsorGenoPharmaceuticals Inc.
        • sponsor_typeIndustry
        • contact_personMr. John Smith
        • address789 Pharma Avenue, MedTech City, State, ZIP
        • telephone_number+1 (800) 555-1234
        • fax_number+1 (800) 555-5678
        • cell_number+1 (800) 555-9012
        • email_addressinfo@genopharmaceuticals.com
        • created2024-06-11 04:05:15
        • modified2024-06-11 09:01:24
  • 1(array)
    • Application(array)
      • id127
      • user_id26
      • application_id(null)
      • is_child0
      • trial_status_id7
      • total_sites3
      • abstract_of_study<p>\n test</p>\n
      • study_title<p>\n Laborum Doloribus illo impedi</p>\n
      • laymans_summary<p>\n test</p>\n
      • short_titleLaborum Doloribus illo impedi
      • protocol_noECCT/25/01/01
      • reference_no
      • version_noEt duis deserunt tempor blanditiis omnis cum distinctio
      • date_of_protocol15-01-1977
      • study_drugOccaecat quidem sunt officia adipisci aperiam reprehenderit illo error culpa atque ut voluptas sit vero
      • disease_conditionImpedit eaque facilis dignissimos magni dolorem sit dolore in quia modi cumque dicta
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals1
      • product_type_vaccines0
      • product_type_hormones1
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device1
      • product_type_chemical_nameAmela Wiley
      • product_type_medical_device_nameMiranda Fry
      • comparatorYes
      • comparator_nameHolmes Tanner
      • comparator_registeredEnim aperiam incidunt est ut
      • comparator_countriesDeserunt eiusmod ver
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressqimuvo@mailinator.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement0
      • declaration_applicantUnde lorem aut expedita sed assumenda sint qui cupiditate
      • declaration_date108-12-2013
      • declaration_principal_investigatorError tempor odit dicta aute perferendis autem cum doloribus omnis odio quaerat nihil reiciendis quasi eos minima itaque
      • declaration_date207-01-2025
      • placebo_presentYes
      • study_objectives<p>\n test</p>\n
      • principal_inclusion_criteria<p>\n test</p>\n
      • principal_exclusion_criteria<p>\n test</p>\n
      • primary_end_points<p>\n test</p>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic1
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study1
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n test</p>\n
      • other_details_explanation<p>\n test</p>\n
      • other_details_regulatory_notapproved<p>\n tets</p>\n
      • other_details_regulatory_approved<p>\n test</p>\n
      • other_details_regulatory_rejected<p>\n tets</p>\n
      • other_details_regulatory_halted<p>\n test</p>\n
      • estimated_durationEx qui assumenda laudantium eos dolor voluptatem Quaerat vero ut ex voluptatem corporis neque laborum Irure
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states20
      • number_of_sites2
      • multi_country_listEos aute voluptatem
      • data_monitoring_committeeNo
      • total_enrolment_per_site200
      • total_participants_worldwideVoluptatem incididunt nostrud sint error nobis itaque nisi enim
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornYes
      • population_newbornYes
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female0
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenYes
      • subjects_nursing_womenUnclear
      • subjects_emergency_situationYes
      • subjects_incapable_consentYes
      • subjects_specifyLabore quae cum qui
      • subjects_othersYes
      • subjects_others_specifyVoluptate qui sed al
      • investigator1_given_nameRemedios Steele
      • investigator1_middle_nameTaShya Moore
      • investigator1_family_nameBrady Key
      • investigator1_qualificationEveniet laudantium doloremque provident illo maiores asperiores animi totam reiciendis corporis est
      • investigator1_professional_addressVoluptatibus voluptates nemo sit et lorem
      • investigator1_telephone+1 (974) 807-5529
      • investigator1_emailcuvicenuwy@mailinator.com
      • organisations_transferred_No
      • number_participants20000
      • notification<p>\n test</p>\n
      • approval_date07-01-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted07-01-2025
      • unsubmitted1
      • initial_date_submitted07-01-2025
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasontest
      • approved_date(null)
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • ecitizen_invoice343770
      • modified2025-02-18 08:53:19
      • created2025-01-06 15:07:01
      • ai_content(null)
    • InvestigatorContact(array)
      • 0(array)
        • id84
        • application_id127
        • given_nameAidan Madden
        • middle_nameYeo Christensen
        • family_nameNola Nielsen
        • qualificationNecessitatibus sed amet quia mollitia quia magnam nostrum elit vel et repellendus Culpa
        • professional_addressConsectetur iure ea blanditiis illo facilis sed magna elit non alias
        • telephone+1 (375) 498-2766
        • emailtomap@mailinator.com
        • investigator_roleprincipal
        • created2025-01-06 15:08:18
        • modified2025-02-06 14:33:08
    • SiteDetail(array)
      • 0(array)
        • id129
        • application_id127
        • county_id38
        • site_nameIsadora Long
        • physical_addressQuas aut corporis in ea incidunt eligendi voluptas tempora sed ex et eiusmod illum ipsam quibusdam delectus officia exercitationem velit
        • contact_detailsP.O. Box 5
        • contact_personAnimi et porro velit excepturi vitae lorem excepturi iusto est labore excepturi ipsa sunt ad beatae velit
        • site_capacity(null)
        • misc(null)
        • created2013-06-27 11:37:16
        • modified2025-02-06 14:33:08
        • County(array)
          • id38
          • county_nameVihiga
          • created2012-06-15 10:26:37
          • modified2012-06-15 10:26:37
    • Sponsor(array)
      • 0(array)
        • id34
        • application_id127
        • sponsorFugit nulla amet numquam veniam qui minim ratione ducimus voluptatem Eos molestiae obcaecati est repudiandae aut id Nam enim ut
        • sponsor_typeResearch Institution
        • contact_personQuasi voluptas voluptate veritatis quis
        • addressVoluptatem Sit eum voluptas nobis aliqua Nostrud minus officia voluptatum eveniet vel lorem aperiam cupidatat
        • telephone_number+1 (924) 838-9502
        • fax_number+1 (461) 834-7154
        • cell_number+1 (976) 269-8435
        • email_addressgopokilos@mailinator.com
        • created2025-01-06 15:08:18
        • modified2025-02-06 14:33:08
  • 2(array)
    • Application(array)
      • id231
      • user_id29
      • application_id(null)
      • is_child0
      • trial_status_id6
      • total_sites2
      • abstract_of_study<p>\n Sample</p>\n
      • study_title<p>\n Sample sample</p>\n
      • laymans_summary<p>\n test</p>\n
      • short_titleTest
      • protocol_noECCT/25/07/01
      • reference_no
      • version_no3
      • date_of_protocol11-07-2025
      • study_drugSample
      • disease_conditionSample
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals1
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_namesample
      • product_type_medical_device_name
      • comparatorYes
      • comparator_namesample
      • comparator_registeredsample
      • comparator_countriessample,sample
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjkiprotich@intellisoftkenya.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd0
      • applicant_prev_data0
      • applicant_stability_data0
      • applicant_analysis_cert0
      • applicant_pictorial_sample0
      • applicant_gcp_training0
      • applicant_dsmb_charter0
      • applicant_detailed_budget0
      • applicant_indemnity_pi0
      • applicant_practice_license0
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist0
      • statistical_analysis_plan0
      • applicant_contractual_agreement0
      • declaration_applicantsample sample
      • declaration_date111-07-2025
      • declaration_principal_investigatorSample Sample
      • declaration_date211-07-2025
      • placebo_presentNo
      • study_objectives<p>\n sample sample</p>\n
      • principal_inclusion_criteria<p>\n saample</p>\n
      • principal_exclusion_criteria<p>\n sample</p>\n
      • primary_end_points<p>\n sample</p>\n
      • scope_diagnosis1
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans1
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n sample sample</p>\n
      • other_details_explanation<p>\n sample sample</p>\n
      • other_details_regulatory_notapproved<p>\n sample</p>\n
      • other_details_regulatory_approved<p>\n sample</p>\n
      • other_details_regulatory_rejected<p>\n sample</p>\n
      • other_details_regulatory_halted<p>\n sample</p>\n
      • estimated_duration3
      • 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_areasample sample
      • single_site_physical_addresssample sample
      • single_site_contact_personsample
      • single_site_telephone0733098232
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site40
      • total_participants_worldwide40
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_namesample sample
      • investigator1_middle_namesample
      • investigator1_family_namesample sample
      • investigator1_qualificationsample
      • investigator1_professional_addresssample
      • investigator1_telephone0700543987
      • investigator1_emailsample@gmail.com
      • organisations_transferred_No
      • number_participants30
      • notification<p>\n Sample docs</p>\n
      • approval_date30-09-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted11-07-2025
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasontest
      • approved_date(null)
      • final_report<p>\n test</p>\n
      • implication_results<p>\n test</p>\n
      • quantity_imported3
      • quantity_dispensed3
      • quantity_destroyed3
      • quantity_exported3
      • balance_site3
      • final_date2025-09-30
      • ecitizen_invoice363835
      • modified2026-02-17 10:47:21
      • created2025-03-27 12:53:06
      • ai_content(null)
    • InvestigatorContact(array)
      • 0(array)
        • id146
        • application_id231
        • given_nameKiprotich
        • middle_nameKeter
        • family_nameJapheth
        • qualificationNurse
        • professional_addresssample
        • telephone0724743789
        • emailitsjkiprotich@gmail.com
        • investigator_roleprincipal
        • created2025-03-27 12:53:06
        • modified2025-07-11 17:33:23
    • SiteDetail(array)
      • 0(array)
        • id205
        • application_id231
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2013-10-18 13:57:09
        • modified2025-07-11 17:33:23
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id56
        • application_id231
        • sponsorsample sample
        • sponsor_typeIndustry
        • contact_person
        • addresssample
        • telephone_number07005439282
        • fax_number
        • cell_number07005439292
        • email_addresssample@gmail.com
        • created2025-03-27 12:54:56
        • modified2025-07-11 17:33:23
  • 3(array)
    • Application(array)
      • id2
      • user_id29
      • application_id(null)
      • is_child0
      • trial_status_id4
      • total_sites2
      • abstract_of_study<p>\n Abstract</p>\n
      • study_title<p>\n Sample Title</p>\n
      • laymans_summary<p>\n Some Summary</p>\n
      • short_titleShort Title
      • protocol_noECCT/24/01/01
      • reference_no(null)
      • version_nov12
      • date_of_protocol09-01-2024
      • study_drugName
      • disease_conditionSome condition
      • product_type_biologicals1
      • product_type_proteins1
      • product_type_immunologicals1
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device1
      • product_type_chemical_namechemical name
      • product_type_medical_device_namemedical device
      • comparatorYes
      • comparator_nameSome
      • comparator_registeredSome
      • comparator_countriesSome
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjkiprotich@intellisoftkenya.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantsome
      • declaration_date109-01-2024
      • declaration_principal_investigatorsome
      • declaration_date209-01-2024
      • placebo_presentNo
      • study_objectives<p>\n objectives</p>\n
      • principal_inclusion_criteria<p>\n inclusion</p>\n
      • principal_exclusion_criteria<p>\n exclusion</p>\n
      • primary_end_points<p>\n end points</p>\n
      • scope_diagnosis1
      • scope_prophylaxis1
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • scope_bioequivalence1
      • scope_dose_response1
      • scope_pharmacogenetic1
      • scope_pharmacogenomic1
      • scope_pharmacoecomomic1
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study1
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n some capacity</p>\n
      • other_details_explanation<p>\n some</p>\n
      • other_details_regulatory_notapproved<p>\n some</p>\n
      • other_details_regulatory_approved<p>\n some</p>\n
      • other_details_regulatory_rejected<p>\n some</p>\n
      • other_details_regulatory_halted<p>\n some</p>\n
      • estimated_duration3some
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states4
      • number_of_sites
      • multi_country_listsome four states here
      • data_monitoring_committeeYes
      • total_enrolment_per_site30
      • total_participants_worldwide50
      • population_less_than_18_yearsYes
      • population_uteroYes
      • population_preterm_newbornNo
      • population_newbornYes
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenYes
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifysome
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_namesome
      • investigator1_middle_namesome
      • investigator1_family_namesome
      • investigator1_qualificationsome
      • investigator1_professional_addresssome
      • investigator1_telephone254700234871
      • investigator1_emailsample@gmail.com
      • organisations_transferred_No
      • number_participants20
      • notification<p>\n None</p>\n
      • approval_date13-01-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted22-05-2024
      • unsubmitted1
      • initial_date_submitted22-05-2024
      • admin_stopped1
      • admin_stopped_reasonVillation
      • approved2
      • approved_reasonHey
      • approved_date(null)
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • ecitizen_invoice301439
      • modified2025-02-13 09:04:41
      • created2024-01-09 05:09:48
      • ai_content(null)
    • InvestigatorContact(array)
      • 0(array)
        • id2
        • application_id2
        • given_namesome name principal
        • middle_namesome name principal
        • family_namesome name principal
        • qualificationsome qualofication
        • professional_addresssome address
        • telephone254700282716
        • emailsome@gmail.com
        • investigator_roleprincipal
        • created2024-01-09 05:37:44
        • modified2024-06-25 08:22:28
    • SiteDetail(array)
      • 0(array)
        • id1639
        • application_id2
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2024-01-09 05:37:44
        • modified2024-06-25 08:22:28
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id14
        • application_id2
        • sponsorsome sponsor
        • sponsor_typeIndustry
        • contact_personsome contact person
        • addressaddress
        • telephone_number0700432422
        • fax_number
        • cell_number0700434343
        • email_addresssponsor@gmail.com
        • created2024-05-22 16:52:09
        • modified2024-06-25 08:22:28
  • 4(array)
    • Application(array)
      • id125
      • user_id29
      • application_id(null)
      • is_child0
      • trial_status_id10
      • total_sites5
      • abstract_of_study<p>\n sample</p>\n
      • study_title<p>\n sample</p>\n
      • laymans_summary<p>\n sample</p>\n
      • short_titleEt eius sit aut et fugiat adi
      • protocol_noECCT/24/12/01
      • reference_no(null)
      • version_noDolorem veniam pariatur Consequat Numquam et digniss
      • date_of_protocol01-12-2024
      • study_drugId debitis rerum natus molestiae reprehenderit doloremque recusandae Ratione perspiciatis velit minim delectus similique suscipit fugiat
      • disease_conditionTempor numquam voluptas amet aut tempore repellendus Magni pariatur
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals1
      • product_type_vaccines0
      • product_type_hormones1
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device1
      • product_type_chemical_nameStone Atkins
      • product_type_medical_device_nameAnthony Lawrence
      • comparatorNo
      • comparator_nameSydnee Woods
      • comparator_registeredEt sint officia eos asperiore
      • comparator_countriesVel anim voluptatem
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjkiprotich@intellisoftkenya.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantQuo tenetur ex ut tempora consequatur rerum qui amet officiis sed molestiae fuga Quibusdam velit eu soluta voluptates amet
      • declaration_date117-12-2024
      • declaration_principal_investigatorSint explicabo Sint quos omnis quia aliquid non ullamco ipsum quia dignissimos qui et consequat Voluptatum cupidatat aut
      • declaration_date217-12-2024
      • placebo_presentYes
      • study_objectives<p>\n sample</p>\n
      • principal_inclusion_criteria<p>\n sample</p>\n
      • principal_exclusion_criteria<p>\n sample</p>\n
      • primary_end_points<p>\n sample</p>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic1
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study1
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n sample</p>\n
      • other_details_explanation<p>\n sample</p>\n
      • other_details_regulatory_notapproved<p>\n sample</p>\n
      • other_details_regulatory_approved<p>\n sample</p>\n
      • other_details_regulatory_rejected<p>\n sample</p>\n
      • other_details_regulatory_halted<p>\n sample</p>\n
      • estimated_duration4
      • design_controlled_randomisedNo
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overYes
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorRecusandae Fuga Ut est
      • design_controlled_other_medicinalYes
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites543
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_siteQuidem in duis fugia
      • total_participants_worldwideSit ut quae amet at tempor et commodo voluptas quod neque adipisci nemo labore Nam officia ut commodi
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentYes
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenYes
      • subjects_emergency_situationYes
      • subjects_incapable_consentYes
      • subjects_specifyFacilis quia totam u
      • subjects_othersYes
      • subjects_others_specifyNulla ipsam dolore i
      • investigator1_given_nameDominique Solomon
      • investigator1_middle_nameHyacinth Bond
      • investigator1_family_nameIndira Shaffer
      • investigator1_qualificationRerum adipisicing magnam qui rerum nemo dicta eligendi quis inventore provident accusantium aperiam ipsum enim qui asperiores
      • investigator1_professional_addressSit aut at tenetur enim culpa
      • investigator1_telephone+1 (956) 653-5189
      • investigator1_emailpydekizef@mailinator.com
      • organisations_transferred_Yes
      • number_participantsVoluptatum aliqua I
      • notification<p>\n sample</p>\n
      • approval_date17-12-2024
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted17-12-2024
      • unsubmitted1
      • initial_date_submitted17-12-2024
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • approved_date(null)
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • ecitizen_invoice(null)
      • modified2025-01-07 08:39:12
      • created2024-11-29 09:22:21
      • ai_content(null)
    • InvestigatorContact(array)
      • 0(array)
        • id81
        • application_id125
        • given_nameLawrence Jennings
        • middle_nameAladdin Powers
        • family_nameElton Delgado
        • qualificationUllam deleniti aliqua Excepteur nisi id dolorum vel ipsum a irure repudiandae molestias aut quos suscipit et dolore reprehenderit eu
        • professional_addressUt facere ea aliquam eveniet
        • telephone+1 (328) 771-3449
        • emailxycuqez@mailinator.com
        • investigator_roleprincipal
        • created2024-12-17 08:32:23
        • modified2025-01-06 11:48:30
    • SiteDetail(array)
      • 0(array)
        • id1705
        • application_id125
        • county_id25
        • site_nameChastity Horne
        • physical_addressA alias veritatis aute asperiores voluptatem anim id irure veniam qui
        • contact_detailsPO Box 91937
        • contact_personAtque esse sint consectetur qui tempor dicta sit illo id consectetur illo qui quo soluta
        • site_capacity(null)
        • misc(null)
        • created2024-12-17 08:32:23
        • modified2025-01-06 11:48:30
        • County(array)
          • id25
          • county_nameSamburu
          • created2012-06-15 10:24:58
          • modified2012-06-15 10:24:58
    • Sponsor(array)
      • 0(array)
        • id33
        • application_id125
        • sponsorDolore sunt reprehenderit voluptas commodi asperiores
        • sponsor_typeIndustry
        • contact_personAd consequatur nulla aut quo explicabo Eligendi similique ex cum sed voluptas sint sit dolorem nulla asperiores suscipit
        • addressQuis ipsa voluptatum non officia nisi minus officia est et
        • telephone_number+1 (498) 749-6935
        • fax_number+1 (547) 888-9241
        • cell_number+1 (941) 425-9332
        • email_addresscidesy@mailinator.com
        • created2024-12-17 08:32:23
        • modified2025-01-06 11:48:30
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(array)
    • trial_therapeutic_exploratory1
• $this->validationErrors(array)
  • Permission(empty)
  • Aro(empty)
  • Aco(empty)
  • Application(empty)
  • User(empty)
  • TrialStatus(empty)
  • InvestigatorContact(empty)
  • Sponsor(empty)
  • SiteDetail(empty)
  • County(empty)
• Loaded Helpers(array)
  • 0Html
  • 1Form
  • 2Session
  • 3Text
  • 4Number
  • 5SimpleGraph
  • 6Paginator
  • 7DebugTimer
  • 8Toolbar
  • 9HtmlToolbar

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

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

Included Files

• core(array)
  • Behavior(array)
    • 0CORE/Model/Behavior/TreeBehavior.php
    • 1CORE/Model/Behavior/ContainableBehavior.php
    • 2CORE/Model/Behavior/AclBehavior.php
  • Cache(array)
    • 0CORE/Cache/Cache.php
    • 1CORE/Cache/Engine/FileEngine.php
    • 2CORE/Cache/CacheEngine.php
  • Component(array)
    • 0CORE/Controller/Component/AclComponent.php
    • 1CORE/Controller/Component/Acl/DbAcl.php
    • 2CORE/Controller/Component/Acl/AclInterface.php
    • 3CORE/Controller/Component/AuthComponent.php
    • 4CORE/Controller/Component/RequestHandlerComponent.php
    • 5CORE/Controller/Component/SessionComponent.php
    • 6CORE/Controller/Component/PaginatorComponent.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
    • 7CORE/Utility/Sanitize.php
  • View(array)
    • 0CORE/View/HelperCollection.php
• app(array)
  • Behavior(array)
    • 0APP/Model/Behavior/SoftDeleteBehavior.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/InvestigatorContact.php
    • 5APP/Model/Sponsor.php
    • 6APP/Model/SiteDetail.php
    • 7APP/Model/County.php
  • Other(array)
    • 0APP/webroot/index.php
• plugins(array)
  • CakePdf(array)
    • Config(array)
      • 0CakePdf/Config/bootstrap.php
      • 1CakePdf/Config/routes.php
  • CakeResque(array)
    • Config(array)
      • 0CakeResque/Config/bootstrap.php
    • Plugin(array)
      • 0CakeResque/Lib/CakeResque.php
      • 1CakeResque/vendor/kamisama/php-resque-ex/lib/Resque.php
      • 2CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Event.php
      • 3CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Exception.php
  • DebugKit(array)
    • Component(array)
      • 0DebugKit/Controller/Component/ToolbarComponent.php
    • Plugin(array)
      • 0DebugKit/Lib/DebugMemory.php
      • 1DebugKit/Lib/Panel/HistoryPanel.php
      • 2DebugKit/Lib/DebugPanel.php
      • 3DebugKit/Lib/Panel/SessionPanel.php
      • 4DebugKit/Lib/Panel/RequestPanel.php
      • 5DebugKit/Lib/Panel/SqlLogPanel.php
      • 6DebugKit/Lib/Panel/TimerPanel.php
      • 7DebugKit/Lib/Panel/LogPanel.php
      • 8DebugKit/Lib/Log/Engine/DebugKitLog.php
      • 9DebugKit/Lib/Panel/VariablesPanel.php
      • 10DebugKit/Lib/Panel/EnvironmentPanel.php
      • 11DebugKit/Lib/Panel/IncludePanel.php
      • 12DebugKit/Lib/DebugTimer.php
  • Media(array)
    • Config(array)
      • 0Media/Config/bootstrap.php
    • Plugin(array)
      • 0Media/Lib/mm/src/Mime/Type.php
      • 1Media/Lib/mm/src/Mime/Type/Magic/Adapter/Fileinfo.php
      • 2Media/Lib/mm/src/Mime/Type/Magic/Adapter.php
      • 3Media/Lib/mm/src/Mime/Type/Glob/Adapter/Memory.php
      • 4Media/Lib/mm/src/Mime/Type/Glob/Adapter.php
      • 5Media/Lib/mm/src/Media/Process.php
      • 6Media/Lib/mm/src/Media/Info.php
  • 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