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  • Application(array)
    • id98
    • user_id26
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    • abstract_of_study<p>  This randomized controlled trial investigates the efficacy and safety of a novel immunotherapy in patients with advanced melanoma. A total of 300 participants will be randomly assigned to receive either the new immunotherapy or a standard treatment. The primary outcome measures include overall survival rate, progression-free survival, and incidence of adverse events over a 24-month period. Secondary outcomes will assess quality of life and biomarker responses. Preliminary data suggests that the new therapy may improve survival rates with manageable side effects. This study aims to provide robust evidence on the potential benefits and risks of this innovative treatment, potentially offering a new standard of care for advanced melanoma patients.</p> <p>  </p>
    • study_title<p> Efficacy and Safety of Novel Immunotherapy in Treating Advanced Melanoma: A Randomized Controlled Tria</p>
    • laymans_summary<p> This study tests a new treatment for advanced skin cancer (melanoma). Researchers are checking if this new therapy is both effective and safe. They are comparing it to other treatments by giving it to some patients and not others, then seeing how well it works and if there are any side effects.</p>
    • short_titleStudy 3
    • protocol_noECCT/24/06/05
    • reference_no(null)
    • version_no1.2
    • date_of_protocol20-06-2024
    • study_drugNivolumab
    • disease_condition Non-Small Cell Lung Cancer (NSCLC)
    • product_type_biologicals1
    • product_type_proteins1
    • product_type_immunologicals0
    • product_type_vaccines0
    • product_type_hormones0
    • product_type_toxoid0
    • product_type_chemical1
    • product_type_medical_device0
    • product_type_chemical_name Nivolumab
    • product_type_medical_device_name
    • comparatorNo
    • comparator_name
    • comparator_registered
    • comparator_countries
    • ecct_not_applicable0
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    • email_addressjayoma@intellisoftkenya.com
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    • declaration_applicantJospeh McCathy
    • declaration_date120-06-2024
    • declaration_principal_investigatorPI Inv
    • declaration_date220-06-2024
    • placebo_presentYes
    • study_objectives<ol> <li> <p> <strong>Primary Objective:</strong></p> <ul> <li> To compare the overall survival (OS) of patients with advanced melanoma treated with nivolumab versus standard-of-care chemotherapy.</li> </ul> </li> <li> <p> <strong>Secondary Objective:</strong></p> <ul> <li> To assess the progression-free survival (PFS) in patients receiving nivolumab compared to those receiving standard chemotherapy.</li> <li> To evaluate the safety profile and incidence of adverse events associated with nivolumab treatment.</li> <li> To explore biomarkers that may predict response to nivolumab therapy in advanced melanoma patients.</li> </ul> </li> </ol> <h3>  </h3>
    • principal_inclusion_criteria<ul> <li> <p> <strong>Histologically confirmed diagnosis of advanced melanoma:</strong></p> <ul> <li> Patients must have histologically confirmed unresectable stage III or stage IV melanoma.</li> </ul> </li> <li> <p> <strong>Prior treatment history:</strong></p> <ul> <li> Patients must have received prior treatment with a BRAF inhibitor (if BRAF V600 mutation positive) or have progressed on or after anti-PD-1/L1 therapy.</li> </ul> </li> </ul>
    • principal_exclusion_criteria<ol> <li> <p> <strong>Autoimmune disease:</strong></p> <ul> <li> Patients with a history of autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus) requiring systemic treatment within the past 2 years are excluded.</li> </ul> </li> <li> <p> <strong>Active brain metastases:</strong></p> <ul> <li> Patients with untreated or symptomatic brain metastases are excluded unless they have completed local therapy and are neurologically stable without corticosteroid treatment for at least 4 weeks.</li> </ul> </li> </ol>
    • primary_end_points<ul> <li> <p> <strong>Primary Endpoint 1: Overall Survival (OS)</strong></p> <ul> <li> The primary endpoint is the comparison of overall survival between patients treated with nivolumab and those receiving standard chemotherapy. OS is defined as the time from randomization until death from any cause.</li> </ul> </li> <li> <p> <strong>Primary Endpoint 2: Progression-Free Survival (PFS)</strong></p> <ul> <li> Another primary endpoint is the comparison of progression-free survival between the nivolumab and standard chemotherapy groups. PFS is defined as the time from randomization to disease progression or death from any cause, whichever occurs first.</li> </ul> </li> </ul>
    • scope_diagnosis0
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    • site_capacity(null)
    • staff_numbers<p> <strong>Capacity of Site:</strong></p> <ul> <li> Specializes in oncology research and treatment.</li> <li> Large capacity for clinical trials with dedicated research units.</li> </ul> <p> <strong>Number of Staff and Facilities:</strong></p> <ul> <li> <p> <strong>Study Coordinators:</strong></p> <ul> <li> Sarah Elizabeth Johnson, MD, PhD (Coordinating Investigator)</li> <li> Emily Jane Carter, PharmD (Pharmacist)</li> </ul> </li> <li> <p> <strong>Other Staff:</strong></p> <ul> <li> Oncologists, nurses, research assistants with experience in oncology.</li> </ul> </li> <li> <p> <strong>Site Facilities:</strong></p> <ul> <li> State-of-the-art research labs.</li> <li> Dedicated infusion centers.</li> <li> Imaging facilities (MRI, CT scans).</li> <li> Patient monitoring and emergency response systems.</li> </ul> </li> <li> <p> <strong>Emergency Facilities:</strong></p> <ul> <li> Close proximity to emergency departments within the hospital.</li> <li> Dedicated emergency response teams for clinical trials.</li> </ul> </li> </ul>
    • other_details_explanation<p> <strong>Reasons for Conducting the Trial in Kenya:</strong></p> <ol> <li> <p> <strong>Access to Diverse Patient Population:</strong></p> <ul> <li> Kenya offers access to a diverse population of patients with advanced melanoma who may have different genetic backgrounds and disease characteristics compared to the host country of the sponsor. This diversity enhances the generalizability of study findings.</li> </ul> </li> <li> <p> <strong>Clinical Trial Infrastructure:</strong></p> <ul> <li> Kenya has established clinical trial infrastructure, including research centers and experienced healthcare professionals, capable of conducting oncology trials. This infrastructure supports efficient patient recruitment and trial execution.</li> </ul> </li> </ol> <h3>  </h3>
    • other_details_regulatory_notapproved<p> <strong>Name of Regulatory Authorities:</strong></p> <ul> <li> FDA (Food and Drug Administration), USA</li> <li> EMA (European Medicines Agency), EU</li> </ul> <p> <strong>Date(s) of Application:</strong></p> <ul> <li> FDA: January 15, 2024</li> <li> EMA: February 1, 2024</li> </ul> <h3>  </h3>
    • other_details_regulatory_approved<ul> <li> <p> <strong>FDA (Food and Drug Administration), USA</strong></p> <ul> <li> <strong>Date of Approval:</strong> May 15, 2024</li> <li> <strong>Number of Sites per Country:</strong> <ul> <li> USA: 25 sites</li> </ul> </li> </ul> </li> <li> <p> <strong>EMA (European Medicines Agency), EU</strong></p> <ul> <li> <strong>Date of Approval:</strong> June 1, 2024</li> <li> <strong>Number of Sites per Country:</strong> <ul> <li> Germany: 15 sites</li> <li> France: 10 sites</li> <li> Spain: 8 sites</li> </ul> </li> </ul> </li> </ul>
    • other_details_regulatory_rejected<p> N/A</p>
    • other_details_regulatory_halted<p> N/A</p>
    • estimated_duration36months
    • design_controlled_randomisedYes
    • design_controlled_openYes
    • design_controlled_single_blindNo
    • design_controlled_double_blindNo
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    • location_of_areaSite1
    • single_site_physical_addressadmin site
    • single_site_contact_personTest
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    • data_monitoring_committeeYes
    • total_enrolment_per_site200000
    • total_participants_worldwide200000000
    • population_less_than_18_yearsNo
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    • subjects_others_specify
    • investigator1_given_nameSarah
    • investigator1_middle_name
    • investigator1_family_nameJohnson
    • investigator1_qualificationMD, PhD
    • investigator1_professional_addressDepartment of Oncology Memorial Sloan Kettering Cancer Center 1275 York Avenue New York, NY 10065 United States
    • investigator1_telephone+1 212-639-2000
    • investigator1_emailsjohnson@mskcc.org
    • organisations_transferred_Yes
    • number_participants200000
    • notification<p> NA</p>
    • approval_date20-06-2024
    • submitted1
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    • date_submitted20-06-2024
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    • initial_date_submitted20-06-2024
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    • ecitizen_invoice305955
    • modified2024-07-16 10:06:14
    • created2024-06-20 10:32:00
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    • nameJavan
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    • county_id47
    • country_id115
    • group_id5
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    • is_active1
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    • created2024-01-17 15:58:25
    • modified2024-05-21 07:37:41
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      • date_submitted2024-07-30 14:50:11
      • modified2024-07-30 14:50:11
      • created2024-07-30 14:48:42
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      • modified2024-07-30 14:52:03
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      • created2024-06-20 10:32:00
      • modified2024-06-25 08:51:45
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      • end_date2024-06-20
      • created2024-06-20 12:05:45
      • modified2024-06-20 12:05:45
    • 1(array)
      • id192
      • application_id98
      • stageScreeningSubmission
      • start_date2024-06-20
      • statusComplete
      • commentManager final decision
      • end_date2024-06-20
      • created2024-06-20 12:07:04
      • modified2024-06-20 12:07:04
    • 2(array)
      • id193
      • application_id98
      • stageAssign
      • start_date2024-06-20
      • statusComplete
      • commentManager final decision
      • end_date2024-06-20
      • created2024-06-20 12:07:04
      • modified2024-06-20 12:07:04
    • 3(array)
      • id194
      • application_id98
      • stageReview
      • start_date2024-06-20
      • statusComplete
      • commentManager final decision
      • end_date2024-06-20
      • created2024-06-20 12:07:04
      • modified2024-06-20 12:07:04
    • 4(array)
      • id195
      • application_id98
      • stageReviewSubmission
      • start_date2024-06-20
      • statusCurrent
      • commentManager new comment
      • end_date(null)
      • created2024-06-20 12:07:04
      • modified2024-06-20 12:07:04
    • 5(array)
      • id196
      • application_id98
      • stageFinalDecision
      • start_date2024-06-20
      • statusComplete
      • commentManager final decision
      • end_date2024-06-20
      • created2024-06-20 12:07:04
      • modified2024-06-20 12:07:04
    • 6(array)
      • id197
      • application_id98
      • stageAnnualApproval
      • start_date2024-06-20
      • statusCurrent
      • commentManager letter approve
      • end_date2025-07-30
      • created2024-06-20 12:07:04
      • modified2024-06-20 12:07:04
    • 7(array)
      • id198
      • application_id98
      • stageUnsubmitted
      • start_date2024-06-25
      • statusComplete
      • commentPrincipal Investigator Re Submission
      • end_date2024-06-25
      • created2024-06-25 08:09:34
      • modified2024-06-25 08:09:34
  • Pharmacist(array)
    • 0(array)
      • id23
      • application_id98
      • reg_no123456789
      • given_nameEmily Jane Carter
      • premise_nameMemorial Sloan Kettering Cancer Center Pharmac
      • qualificationPharmD
      • professional_addressMemorial Sloan Kettering Cancer Center 1275 York Avenue New York, NY 10065 United States
      • valid_year2024
      • mobile
      • telephone
      • emailecarter@mskcc.org
      • created2024-06-20 10:55:30
      • modified2024-06-25 08:51:45
  • EthicalCommittee(array)
    • 0(array)
      • id24
      • application_id98
      • ethical_committeeChuka University
      • submission_date10-01-2024
      • erc_numberREF/001/2024
      • initial_approval(null)
      • created2024-06-20 10:55:30
      • modified2024-06-25 08:51:45
  • AnnualLetter(empty)
  • AmendmentLetter(empty)
  • AmendmentApproval(empty)
  • AmendmentApprovalSummary(empty)
  • Organization(array)
    • 0(array)
      • id23
      • application_id98
      • organizationCrowford Organization
      • contact_personJoab Scho
      • addressKilimani Address
      • telephone_number+254789304884
      • all_tasksYes
      • monitoringYes
      • regulatoryYes
      • investigator_recruitmentNo
      • ivrs_treatment_randomisationYes
      • data_managementYes
      • e_data_captureNo
      • susar_reportingYes
      • quality_assurance_auditingYes
      • statistical_analysisYes
      • medical_writingYes
      • other_dutiesNo
      • other_duties_specify
      • misc(null)
      • created2024-06-20 10:55:30
      • modified2024-06-25 08:51:45
  • SiteDetail(array)
    • 0(array)
      • id1701
      • application_id98
      • county_id(null)
      • site_name
      • physical_address
      • contact_details
      • contact_person
      • site_capacity(null)
      • misc(null)
      • created2024-06-20 10:55:30
      • modified2024-06-25 08:51:45
  • Placebo(array)
    • 0(array)
      • id23
      • application_id98
      • placebo_present(null)
      • pharmaceutical_formNeuro
      • route_of_administrationOral
      • compositionchemical
      • identical_indpNo
      • major_ingredientstest
      • created2024-06-20 10:55:30
      • modified2024-06-25 08:51:45
  • Sponsor(array)
    • 0(array)
      • id23
      • application_id98
      • sponsorBioPharma Innovations Ltd.
      • sponsor_typeIndustry
      • contact_person
      • addressBioPharma Innovations Ltd. 123 Main Street San Francisco, CA 94105 United States
      • telephone_number+1 415-555-6789
      • fax_number
      • cell_number+1 415-555-6778
      • email_addressinfo@biopharmainnovations.com
      • created2024-06-20 10:55:30
      • modified2024-06-25 08:51:45
  • SiteInspection(empty)
  • Sae(empty)
  • Ciom(empty)
  • StudyRoute(array)
    • 0(array)
      • id499
      • application_id98
      • study_routesublingual
      • created2024-06-20 10:55:30
      • modified2024-06-25 08:51:45
  • Manufacturer(array)
    • 0(array)
      • id23
      • application_id98
      • manufacturer_nameBristol-Myers Squibb
      • addressBristol-Myers Squibb Company One Squibb Drive New Brunswick, NJ 08903 United States
      • manufacturer_countryLuxembourg
      • manufacturer_phone
      • manufacturer_emailcontactus@bms.com
      • manufacturing_activitiesComplete manufacturing activities
      • other_specify
      • created2024-06-20 10:55:30
      • modified2024-06-25 08:51:45
  • Reassignment(empty)
  • Attachment(empty)
  • AnnualApproval(empty)
  • AmendmentChecklist(array)
    • 0(array)
      • id857
      • modelAmendmentChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/approvalletter_120
      • foreign_key98
      • dirnamegen
      • basenameapprovalletter_120
      • checksuma01891a4bb961d04eda39a76ab140fa5
      • alternative(null)
      • groupamendment
      • description
      • year(null)
      • file_date(null)
      • pocket_name(null)
      • version_no
      • created2024-07-16 10:06:14
      • modified2024-07-16 10:06:14
      • pathgen/approvalletter_120
  • Reminder(empty)
  • ParticipantFlow(empty)
  • Budget(array)
    • 0(array)
      • id23
      • application_id98
      • year(null)
      • budget_period(null)
      • personnel_currencyKES
      • personnel1000
      • transport_currencyKES
      • transport1000
      • field_currencyKES
      • field1000
      • supplies_currencyKES
      • supplies1000
      • pharmacy_currencyKES
      • pharmacy1000
      • travel_currencyKES
      • travel1000
      • regulatory_currencyKES
      • regulatory1000
      • it_currencyKES
      • it1000
      • lab_currency(null)
      • lab(null)
      • others_currencyKES
      • others1000
      • kemri_currency(null)
      • kemri(null)
      • wrair_currency(null)
      • wrair(null)
      • subject_currencyKES
      • subject1000
      • grand_currencyKES
      • grand_total1000
      • study_information
      • personnel_kshs1000
      • transport_kshs1000
      • field_kshs1000
      • supplies_kshs1000
      • pharmacy_kshs1000
      • travel_kshs1000
      • regulatory_kshs1000
      • it_kshs1000
      • lab_kshs(null)
      • others_kshs1000
      • grand_total_kshs1000
      • subject_kshs1000
      • created2024-06-20 10:55:30
      • modified2024-06-25 08:51:45
  • Deviation(array)
    • 0(array)
      • id36
      • application_id98
      • user_id77
      • reference_noDEV/2024/35
      • study_title<p> Efficacy and Safety of Novel Immunotherapy in Treating Advanced Melanoma: A Randomized Controlled Tria</p>
      • deviation_typeDeviation
      • deviation_type_dev
      • pi_nameJavan Ayoma
      • deviation_date25-06-2024
      • participant_numbertest
      • treating_physiciantest
      • deviation_descriptiontest
      • deviation_explanationtest
      • deviation_measurestest
      • deviation_precludetest
      • sponsor_notified1
      • sponsor_explanation(null)
      • study_impacttest
      • statusSubmitted
      • deleted0
      • deleted_date(null)
      • created2024-06-25 09:02:17
      • modified2024-06-25 09:04:11
  • Document(empty)
  • CoverLetter(empty)
  • Protocol(empty)
  • PatientLeaflet(empty)
  • Brochure(empty)
  • GmpCertificate(empty)
  • Cv(empty)
  • Finance(empty)
  • Declaration(empty)
  • IndemnityCover(empty)
  • OpinionLetter(empty)
  • ApprovalLetter(empty)
  • Statement(empty)
  • ParticipatingStudy(empty)
  • Addendum(empty)
  • Registration(empty)
  • Fee(empty)
  • Checklist(array)
    • 0(array)
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      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/doc/1718068595_ppb_12.pdf
      • foreign_key98
      • dirnamedoc
      • basename1718068595_ppb_12.pdf
      • checksumcda3de209e747a08f7876c4a3f0ba560
      • alternative(null)
      • groupapplicant_covering_letter
      • descriptionCover Letter (Should list all the submitted documents, their version numbers and dates) *
      • year(null)
      • file_date20-06-2024
      • pocket_nameapplicant_covering_letter
      • version_no1.0
      • created2024-06-20 11:29:49
      • modified2024-06-25 08:51:45
      • pathdoc/1718068595_ppb_12.pdf
    • 1(array)
      • id787
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/doc/vol_cxxvi_no_85.pdf
      • foreign_key98
      • dirnamedoc
      • basenamevol_cxxvi_no_85.pdf
      • checksum1bda2e9c5a41a43d23272b72524f9bf0
      • alternative(null)
      • groupapplicant_protocol
      • descriptionThe Study Protocol *
      • year(null)
      • file_date20-06-2024
      • pocket_nameapplicant_protocol
      • version_no1.2
      • created2024-06-20 11:30:16
      • modified2024-06-25 08:51:45
      • pathdoc/vol_cxxvi_no_85.pdf
    • 2(array)
      • id789
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/doc/1718085510_ppb.pdf
      • foreign_key98
      • dirnamedoc
      • basename1718085510_ppb.pdf
      • checksumc21d857e321af600d44b5df2bb641c3e
      • alternative(null)
      • groupapplicant_pan_african
      • descriptionRegistration of the study at Pan African Clinical Trials Registry https://pactr.samrc.ac.za *
      • year(null)
      • file_date20-06-2024
      • pocket_nameapplicant_pan_african
      • version_no1.23
      • created2024-06-20 11:31:04
      • modified2024-06-25 08:51:45
      • pathdoc/1718085510_ppb.pdf
    • 3(array)
      • id790
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/doc/2022ckebslcoc0000977171.pdf
      • foreign_key98
      • dirnamedoc
      • basename2022ckebslcoc0000977171.pdf
      • checksum6f9381ad392a5590b2d08df224806751
      • alternative(null)
      • groupapplicant_patient_information
      • descriptionPatient Information leaflet and Informed consent form *
      • year(null)
      • file_date20-06-2024
      • pocket_nameapplicant_patient_information
      • version_no4.0
      • created2024-06-20 11:31:20
      • modified2024-06-25 08:51:45
      • pathdoc/2022ckebslcoc0000977171.pdf
    • 4(array)
      • id791
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/doc/1718026860_ppb_5.pdf
      • foreign_key98
      • dirnamedoc
      • basename1718026860_ppb_5.pdf
      • checksum6dde15055a564939f47a7873f51c867a
      • alternative(null)
      • groupapplicant_investigators_brochure
      • descriptionInvestigators Brochure/Package inserts *
      • year(null)
      • file_date20-06-2024
      • pocket_nameapplicant_investigators_brochure
      • version_no1.5
      • created2024-06-20 11:31:40
      • modified2024-06-25 08:51:45
      • pathdoc/1718026860_ppb_5.pdf
    • 5(array)
      • id792
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/doc/1718026860_ppb_6.pdf
      • foreign_key98
      • dirnamedoc
      • basename1718026860_ppb_6.pdf
      • checksum6dde15055a564939f47a7873f51c867a
      • alternative(null)
      • groupapplicant_impd
      • descriptionInvestigational Medicinal Product Dossier (IMPD) *
      • year(null)
      • file_date20-06-2024
      • pocket_nameapplicant_impd
      • version_no3.3
      • created2024-06-20 11:31:59
      • modified2024-06-25 08:51:45
      • pathdoc/1718026860_ppb_6.pdf
    • 6(array)
      • id793
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/doc/1718026800_ppb_9.pdf
      • foreign_key98
      • dirnamedoc
      • basename1718026800_ppb_9.pdf
      • checksum9bac759a37f0b8d2d1c8269f7373779f
      • alternative(null)
      • groupapplicant_prev_data
      • descriptionAdequate data and information from previous studies and Phases to support carrying out of the current study *
      • year(null)
      • file_date20-06-2024
      • pocket_nameapplicant_prev_data
      • version_no6.4
      • created2024-06-20 11:32:18
      • modified2024-06-25 08:51:45
      • pathdoc/1718026800_ppb_9.pdf
    • 7(array)
      • id794
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/doc/1718026794_ppb_6.pdf
      • foreign_key98
      • dirnamedoc
      • basename1718026794_ppb_6.pdf
      • checksum92949893b8521659174674b8bf2361f8
      • alternative(null)
      • groupapplicant_stability_data
      • descriptionStability data of the investigational product *
      • year(null)
      • file_date20-06-2024
      • pocket_nameapplicant_stability_data
      • version_no3.1
      • created2024-06-20 11:32:40
      • modified2024-06-25 08:51:45
      • pathdoc/1718026794_ppb_6.pdf
    • 8(array)
      • id795
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/doc/1718085586_ppb.pdf
      • foreign_key98
      • dirnamedoc
      • basename1718085586_ppb.pdf
      • checksum6b16f3c9b49a0e0218513dc85c2470f7
      • alternative(null)
      • groupapplicant_gmp_certificate
      • descriptionGMP certificate of the investigational product from the site of manufacture *
      • year(null)
      • file_date20-06-2024
      • pocket_nameapplicant_gmp_certificate
      • version_no2.1
      • created2024-06-20 11:33:02
      • modified2024-06-25 08:51:45
      • pathdoc/1718085586_ppb.pdf
    • 9(array)
      • id796
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/doc/psur_22_6.pdf
      • foreign_key98
      • dirnamedoc
      • basenamepsur_22_6.pdf
      • checksum7f9fcd7b3395094822f219c170e1848d
      • alternative(null)
      • groupapplicant_analysis_cert
      • descriptionCertificate of Analysis of the investigational product *
      • year(null)
      • file_date20-06-2024
      • pocket_nameapplicant_analysis_cert
      • version_no2.3
      • created2024-06-20 11:33:31
      • modified2024-06-25 08:51:45
      • pathdoc/psur_22_6.pdf
    • 10(array)
      • id807
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/doc/sadr_6335_2.pdf
      • foreign_key98
      • dirnamedoc
      • basenamesadr_6335_2.pdf
      • checksum7613000b54d3bdc49ffd4152a791eb40
      • alternative(null)
      • groupapplicant_pictorial_sample
      • descriptionPictorial Sample of the investigational products. This sample should include the text of the labeling to be used *
      • year(null)
      • file_date20-06-2024
      • pocket_nameapplicant_pictorial_sample
      • version_no2.1
      • created2024-06-20 11:41:25
      • modified2024-06-25 08:51:45
      • pathdoc/sadr_6335_2.pdf
    • 11(array)
      • id808
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/doc/wm9c2_15_2024.pdf
      • foreign_key98
      • dirnamedoc
      • basenamewm9c2_15_2024.pdf
      • checksume1dbe7c68a2a6ea1d0b42d7faacf578f
      • 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_date20-06-2024
      • pocket_nameapplicant_investigators_cv
      • version_no1
      • created2024-06-20 11:41:52
      • modified2024-06-25 08:51:45
      • pathdoc/wm9c2_15_2024.pdf
    • 12(array)
      • id809
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/doc/wm9pf_15_2024.pdf
      • foreign_key98
      • dirnamedoc
      • basenamewm9pf_15_2024.pdf
      • checksum02f8fcd32fb002b7628f90ca7d0d5fc7
      • alternative(null)
      • groupapplicant_contractual_agreement
      • descriptionEvidence of contractual agreement between sponsor and Principal Investigator. *
      • year(null)
      • file_date20-06-2024
      • pocket_nameapplicant_contractual_agreement
      • version_no2.1
      • created2024-06-20 11:42:16
      • modified2024-06-25 08:51:45
      • pathdoc/wm9pf_15_2024.pdf
    • 13(array)
      • id810
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/doc/wm9p1_15_2023.pdf
      • foreign_key98
      • dirnamedoc
      • basenamewm9p1_15_2023.pdf
      • checksum336a149865f157000165a74cac7fe580
      • alternative(null)
      • groupapplicant_gcp_training
      • descriptionEvidence of recent GCP training of the core study staff *
      • year(null)
      • file_date20-06-2024
      • pocket_nameapplicant_gcp_training
      • version_no4.5
      • created2024-06-20 11:42:36
      • modified2024-06-25 08:51:45
      • pathdoc/wm9p1_15_2023.pdf
    • 14(array)
      • id811
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/doc/wm9c2_15_2024_2.pdf
      • foreign_key98
      • dirnamedoc
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      • checksume1dbe7c68a2a6ea1d0b42d7faacf578f
      • alternative(null)
      • groupapplicant_dsmb_charter
      • descriptionDSMB Charter including the composition and meeting schedule *
      • year(null)
      • file_date20-06-2024
      • pocket_nameapplicant_dsmb_charter
      • version_no6.2
      • created2024-06-20 11:43:03
      • modified2024-06-25 08:51:45
      • pathdoc/wm9c2_15_2024_2.pdf
    • 15(array)
      • id812
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/doc/wm9p1_15_2023_2.pdf
      • foreign_key98
      • dirnamedoc
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      • checksum336a149865f157000165a74cac7fe580
      • alternative(null)
      • groupapplicant_detailed_budget
      • descriptionDetailed budget of the study *
      • year(null)
      • file_date20-06-2024
      • pocket_nameapplicant_detailed_budget
      • version_no2.1
      • created2024-06-20 11:43:21
      • modified2024-06-25 08:51:45
      • pathdoc/wm9p1_15_2023_2.pdf
    • 16(array)
      • id813
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/doc/helina_open_positions_compressed.pdf
      • foreign_key98
      • dirnamedoc
      • basenamehelina_open_positions_compressed.pdf
      • checksum7563ffecbe524527be9ccc803f5c56f9
      • alternative(null)
      • groupapplicant_financial_declaration
      • descriptionFinancial declaration by Sponsor and/or PI *
      • year(null)
      • file_date20-06-2024
      • pocket_nameapplicant_financial_declaration
      • version_no5.6
      • created2024-06-20 11:43:45
      • modified2024-06-25 08:51:45
      • pathdoc/helina_open_positions_compressed.pdf
    • 17(array)
      • id814
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/doc/helina_open_positions_compressed_1.pdf
      • foreign_key98
      • dirnamedoc
      • basenamehelina_open_positions_compressed_1.pdf
      • checksum7563ffecbe524527be9ccc803f5c56f9
      • 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_date20-06-2024
      • pocket_nameapplicant_signed_declaration
      • version_no3.1
      • created2024-06-20 11:44:07
      • modified2024-06-25 08:51:45
      • pathdoc/helina_open_positions_compressed_1.pdf
    • 18(array)
      • id815
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/doc/helina_open_positions_compressed_2.pdf
      • foreign_key98
      • dirnamedoc
      • basenamehelina_open_positions_compressed_2.pdf
      • checksum7563ffecbe524527be9ccc803f5c56f9
      • alternative(null)
      • groupapplicant_indemnity_pi
      • descriptionIndemnity cover for PI, investigators and study Pharmacist. *
      • year(null)
      • file_date20-06-2024
      • pocket_nameapplicant_indemnity_pi
      • version_no3.2
      • created2024-06-20 11:44:43
      • modified2024-06-25 08:51:45
      • pathdoc/helina_open_positions_compressed_2.pdf
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      • id816
      • modelChecklist
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      • checksum7613000b54d3bdc49ffd4152a791eb40
      • alternative(null)
      • groupapplicant_indemnity_cover
      • descriptionClinical Trials Insurance cover for study participants *
      • year(null)
      • file_date20-06-2024
      • pocket_nameapplicant_indemnity_cover
      • version_no4.2
      • created2024-06-20 11:44:57
      • modified2024-06-25 08:51:45
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      • id827
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      • file/var/www/ctr/app/webroot/media/transfer/doc/sap_certification_infographic_showcase_your_sap_expertise.pdf
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      • dirnamedoc
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      • checksum2edbc0a5ab7431bae03a27b2a7048e5d
      • alternative(null)
      • groupapplicant_opinion_letter
      • descriptionCopy of favorable opinion letter from the local Ethics Review Committee (ERC). *
      • year(null)
      • file_date20-06-2024
      • pocket_nameapplicant_opinion_letter
      • version_no1
      • created2024-06-20 11:49:09
      • modified2024-06-25 08:51:45
      • pathdoc/sap_certification_infographic_showcase_your_sap_expertise.pdf
    • 21(array)
      • id828
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/doc/vol_cxxvi_no_85_2.pdf
      • foreign_key98
      • dirnamedoc
      • basenamevol_cxxvi_no_85_2.pdf
      • checksum1bda2e9c5a41a43d23272b72524f9bf0
      • alternative(null)
      • groupapplicant_practice_license
      • descriptionCopy of current Practice Licenses for the Investigators and study Pharmacist *
      • year(null)
      • file_date20-06-2024
      • pocket_nameapplicant_practice_license
      • version_no2
      • created2024-06-20 11:49:23
      • modified2024-06-25 08:51:45
      • pathdoc/vol_cxxvi_no_85_2.pdf
    • 22(array)
      • id829
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/doc/1717570819_ppb_5.pdf
      • foreign_key98
      • dirnamedoc
      • basename1717570819_ppb_5.pdf
      • checksum711e21b87c720cb2e383806a2c1a41af
      • alternative(null)
      • groupapplicant_approval_letter
      • descriptionCopy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable
      • year(null)
      • file_date20-06-2024
      • pocket_nameapplicant_approval_letter
      • version_no5
      • created2024-06-20 11:49:36
      • modified2024-06-25 08:51:45
      • pathdoc/1717570819_ppb_5.pdf
    • 23(array)
      • id830
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/doc/1718085551_ppb.pdf
      • foreign_key98
      • dirnamedoc
      • basename1718085551_ppb.pdf
      • checksumb8324d8c376288954ce218ca7d4a99e1
      • alternative(null)
      • groupapplicant_addendum
      • descriptionFor multicentre/multi-site studies, a site specific addendum for each of the proposed sites including among other things the sites’ capacity to carry out the study i.e personnel, equipment, laboratory etc
      • year(null)
      • file_date20-06-2024
      • pocket_nameapplicant_addendum
      • version_no1
      • created2024-06-20 11:49:54
      • modified2024-06-25 08:51:45
      • pathdoc/1718085551_ppb.pdf
    • 24(array)
      • id831
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/doc/1718085551_ppb_2.pdf
      • foreign_key98
      • dirnamedoc
      • basename1718085551_ppb_2.pdf
      • checksumb8324d8c376288954ce218ca7d4a99e1
      • alternative(null)
      • groupapplicant_fees
      • descriptionPayment of fees *
      • year(null)
      • file_date20-06-2024
      • pocket_nameapplicant_fees
      • version_no5
      • created2024-06-20 11:50:30
      • modified2024-06-25 08:51:45
      • pathdoc/1718085551_ppb_2.pdf
    • 25(array)
      • id832
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/doc/1718026794_ppb_8.pdf
      • foreign_key98
      • dirnamedoc
      • basename1718026794_ppb_8.pdf
      • checksum92949893b8521659174674b8bf2361f8
      • 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_date20-06-2024
      • pocket_nameapplicant_statement
      • version_no2
      • created2024-06-20 11:50:31
      • modified2024-06-25 08:51:45
      • pathdoc/1718026794_ppb_8.pdf
    • 26(array)
      • id833
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/doc/vol_cxxvi_no_84.pdf
      • foreign_key98
      • dirnamedoc
      • basenamevol_cxxvi_no_84.pdf
      • checksum6c18f22b5f7c846062449eae4fb76ecd
      • alternative(null)
      • groupstatistical_analysis_plan
      • descriptionStatistical Analysis Plan *
      • year(null)
      • file_date20-06-2024
      • pocket_namestatistical_analysis_plan
      • version_no5
      • created2024-06-20 11:50:52
      • modified2024-06-25 08:51:45
      • pathdoc/vol_cxxvi_no_84.pdf
    • 27(array)
      • id834
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/doc/men_s_mental_health_awareness_12.pdf
      • foreign_key98
      • dirnamedoc
      • basenamemen_s_mental_health_awareness_12.pdf
      • checksumd13b37053e0fec6cf5c9474a3dc08f3e
      • alternative(null)
      • groupapplicant_signed_checklist
      • descriptionSigned Checklist *
      • year(null)
      • file_date20-06-2024
      • pocket_nameapplicant_signed_checklist
      • version_no3
      • created2024-06-20 11:51:10
      • modified2024-06-25 08:51:45
      • pathdoc/men_s_mental_health_awareness_12.pdf
  • StudyMonitor(empty)
  • ProtocolOutsource(empty)
  • Outsource(array)
    • 0(array)
      • id3
      • application_id98
      • user_id77
      • model
      • usernamekali
      • namekali
      • emailkali@gmail.com
      • phone_no+254702674563
      • institution_physical
      • name_of_institution
      • institution_address
      • institution_contact
      • county_id(null)
      • country_id115
      • approved1
      • created2024-06-25 08:59:03
      • modified2024-06-25 09:00:02
      • accepted(null)
      • model_sae0
      • model_ciom0
      • model_dev1
• redir
• $request->data(empty)
• $this->validationErrors(array)
  • Permission(empty)
  • Aro(empty)
  • Aco(empty)
  • Application(empty)
  • User(empty)
  • TrialStatus(empty)
  • Review(empty)
  • ActiveInspector(empty)
  • ManagerReview(empty)
  • Acceptance(empty)
  • Amendment(empty)
  • InvestigatorContact(empty)
  • ApplicationStage(empty)
  • Pharmacist(empty)
  • EthicalCommittee(empty)
  • AnnualLetter(empty)
  • AmendmentLetter(empty)
  • AmendmentApproval(empty)
  • AmendmentApprovalSummary(empty)
  • Organization(empty)
  • SiteDetail(empty)
  • Placebo(empty)
  • Sponsor(empty)
  • SiteInspection(empty)
  • Sae(empty)
  • Ciom(empty)
  • StudyRoute(empty)
  • Manufacturer(empty)
  • Reassignment(empty)
  • Attachment(empty)
  • AnnualApproval(empty)
  • AmendmentChecklist(empty)
  • Reminder(empty)
  • ParticipantFlow(empty)
  • Budget(empty)
  • Deviation(empty)
  • Document(empty)
  • CoverLetter(empty)
  • Protocol(empty)
  • PatientLeaflet(empty)
  • Brochure(empty)
  • GmpCertificate(empty)
  • Cv(empty)
  • Finance(empty)
  • Declaration(empty)
  • IndemnityCover(empty)
  • OpinionLetter(empty)
  • ApprovalLetter(empty)
  • Statement(empty)
  • ParticipatingStudy(empty)
  • Addendum(empty)
  • Registration(empty)
  • Fee(empty)
  • Checklist(empty)
  • StudyMonitor(empty)
  • ProtocolOutsource(empty)
  • Outsource(empty)
• Loaded Helpers(array)
  • 0Html
  • 1Form
  • 2Session
  • 3Text
  • 4Number
  • 5SimpleGraph
  • 6DebugTimer
  • 7Toolbar
  • 8HtmlToolbar

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

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

Included Files

• core(array)
  • Behavior(array)
    • 0CORE/Model/Behavior/TreeBehavior.php
    • 1CORE/Model/Behavior/ContainableBehavior.php
    • 2CORE/Model/Behavior/AclBehavior.php
  • Cache(array)
    • 0CORE/Cache/Cache.php
    • 1CORE/Cache/Engine/FileEngine.php
    • 2CORE/Cache/CacheEngine.php
  • Component(array)
    • 0CORE/Controller/Component/AclComponent.php
    • 1CORE/Controller/Component/Acl/DbAcl.php
    • 2CORE/Controller/Component/Acl/AclInterface.php
    • 3CORE/Controller/Component/AuthComponent.php
    • 4CORE/Controller/Component/RequestHandlerComponent.php
    • 5CORE/Controller/Component/SessionComponent.php
  • Config(array)
    • 0CORE/Config/routes.php
    • 1CORE/Config/config.php
  • Controller(array)
    • 0CORE/Controller/Controller.php
    • 1CORE/Controller/ComponentCollection.php
    • 2CORE/Controller/Component.php
  • Datasource(array)
    • 0CORE/Model/Datasource/CakeSession.php
    • 1CORE/Model/Datasource/Database/Mysql.php
    • 2CORE/Model/Datasource/DboSource.php
    • 3CORE/Model/Datasource/DataSource.php
  • Error(array)
    • 0CORE/Error/exceptions.php
    • 1CORE/Error/ErrorHandler.php
  • I18n(array)
    • 0CORE/I18n/I18n.php
    • 1CORE/I18n/L10n.php
  • Log(array)
    • 0CORE/Log/CakeLog.php
    • 1CORE/Log/LogEngineCollection.php
    • 2CORE/Log/Engine/FileLog.php
    • 3CORE/Log/Engine/BaseLog.php
    • 4CORE/Log/CakeLogInterface.php
  • Model(array)
    • 0CORE/Model/ConnectionManager.php
    • 1CORE/Model/Permission.php
    • 2CORE/Model/Model.php
    • 3CORE/Model/BehaviorCollection.php
    • 4CORE/Model/Aro.php
    • 5CORE/Model/AclNode.php
    • 6CORE/Model/Aco.php
    • 7CORE/Model/ModelBehavior.php
  • Network(array)
    • 0CORE/Network/CakeRequest.php
    • 1CORE/Network/CakeResponse.php
  • Other(array)
    • 0CORE/bootstrap.php
    • 1CORE/basics.php
    • 2CORE/Core/App.php
    • 3CORE/Core/Configure.php
    • 4CORE/Core/CakePlugin.php
    • 5CORE/Event/CakeEventListener.php
    • 6CORE/Event/CakeEvent.php
    • 7CORE/Event/CakeEventManager.php
    • 8CORE/Core/Object.php
  • Routing(array)
    • 0CORE/Routing/Dispatcher.php
    • 1CORE/Routing/Filter/AssetDispatcher.php
    • 2CORE/Routing/DispatcherFilter.php
    • 3CORE/Routing/Filter/CacheDispatcher.php
    • 4CORE/Routing/Router.php
    • 5CORE/Routing/Route/CakeRoute.php
    • 6CORE/Routing/Route/PluginShortRoute.php
  • Utility(array)
    • 0CORE/Utility/Hash.php
    • 1CORE/Utility/Inflector.php
    • 2CORE/Utility/ObjectCollection.php
    • 3CORE/Utility/Debugger.php
    • 4CORE/Utility/String.php
    • 5CORE/Utility/ClassRegistry.php
    • 6CORE/Utility/Set.php
  • View(array)
    • 0CORE/View/HelperCollection.php
• app(array)
  • Behavior(array)
    • 0APP/Model/Behavior/SoftDeleteBehavior.php
    • 1APP/Model/Behavior/TimestampBehavior.php
  • Config(array)
    • 0APP/Config/core.php
    • 1APP/Config/bootstrap.php
    • 2APP/Config/routes.php
    • 3APP/Config/database.php
  • Controller(array)
    • 0APP/Controller/ApplicationsController.php
    • 1APP/Controller/AppController.php
  • Model(array)
    • 0APP/Model/AppModel.php
    • 1APP/Model/Application.php
    • 2APP/Model/User.php
    • 3APP/Model/TrialStatus.php
    • 4APP/Model/Review.php
    • 5APP/Model/ActiveInspector.php
    • 6APP/Model/Amendment.php
    • 7APP/Model/InvestigatorContact.php
    • 8APP/Model/ApplicationStage.php
    • 9APP/Model/Pharmacist.php
    • 10APP/Model/EthicalCommittee.php
    • 11APP/Model/AnnualLetter.php
    • 12APP/Model/AmendmentLetter.php
    • 13APP/Model/AmendmentApproval.php
    • 14APP/Model/Organization.php
    • 15APP/Model/SiteDetail.php
    • 16APP/Model/Placebo.php
    • 17APP/Model/Sponsor.php
    • 18APP/Model/SiteInspection.php
    • 19APP/Model/Sae.php
    • 20APP/Model/Ciom.php
    • 21APP/Model/StudyRoute.php
    • 22APP/Model/Manufacturer.php
    • 23APP/Model/Reassignment.php
    • 24APP/Model/Attachment.php
    • 25APP/Model/Reminder.php
    • 26APP/Model/ParticipantFlow.php
    • 27APP/Model/Budget.php
    • 28APP/Model/Deviation.php
    • 29APP/Model/StudyMonitor.php
    • 30APP/Model/ProtocolOutsource.php
    • 31APP/Model/Outsource.php
  • Other(array)
    • 0APP/webroot/index.php
• plugins(array)
  • CakePdf(array)
    • Config(array)
      • 0CakePdf/Config/bootstrap.php
      • 1CakePdf/Config/routes.php
  • CakeResque(array)
    • Config(array)
      • 0CakeResque/Config/bootstrap.php
    • Plugin(array)
      • 0CakeResque/Lib/CakeResque.php
      • 1CakeResque/vendor/kamisama/php-resque-ex/lib/Resque.php
      • 2CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Event.php
      • 3CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Exception.php
  • DebugKit(array)
    • Component(array)
      • 0DebugKit/Controller/Component/ToolbarComponent.php
    • Plugin(array)
      • 0DebugKit/Lib/DebugMemory.php
      • 1DebugKit/Lib/Panel/HistoryPanel.php
      • 2DebugKit/Lib/DebugPanel.php
      • 3DebugKit/Lib/Panel/SessionPanel.php
      • 4DebugKit/Lib/Panel/RequestPanel.php
      • 5DebugKit/Lib/Panel/SqlLogPanel.php
      • 6DebugKit/Lib/Panel/TimerPanel.php
      • 7DebugKit/Lib/Panel/LogPanel.php
      • 8DebugKit/Lib/Log/Engine/DebugKitLog.php
      • 9DebugKit/Lib/Panel/VariablesPanel.php
      • 10DebugKit/Lib/Panel/EnvironmentPanel.php
      • 11DebugKit/Lib/Panel/IncludePanel.php
      • 12DebugKit/Lib/DebugTimer.php
  • Media(array)
    • Config(array)
      • 0Media/Config/bootstrap.php
    • Plugin(array)
      • 0Media/Lib/mm/src/Mime/Type.php
      • 1Media/Lib/mm/src/Mime/Type/Magic/Adapter/Fileinfo.php
      • 2Media/Lib/mm/src/Mime/Type/Magic/Adapter.php
      • 3Media/Lib/mm/src/Mime/Type/Glob/Adapter/Memory.php
      • 4Media/Lib/mm/src/Mime/Type/Glob/Adapter.php
      • 5Media/Lib/mm/src/Media/Process.php
      • 6Media/Lib/mm/src/Media/Info.php
    • Behavior(array)
      • 0Media/Model/Behavior/TransferBehavior.php
      • 1Media/Model/Behavior/CouplerBehavior.php
      • 2Media/Model/Behavior/MetaBehavior.php
  • Search(array)
    • Component(array)
      • 0Search/Controller/Component/PrgComponent.php
    • Behavior(array)
      • 0Search/Model/Behavior/SearchableBehavior.php
  • Shim(array)
    • Config(array)
      • 0Shim/Config/bootstrap.php
  • Tools(array)
    • Config(array)
      • 0Tools/Config/bootstrap.php