UUSOP-06: Study Records Management

Supplement A

Version Date: August 30, 2023

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1. Study Participant Charts should include the following documentation, when applicable:
   • Signed/completed informed consent forms, parental permission forms and/or assent forms
   • Documentation of the informed consent/assent process
   • Documentation of study withdrawal
   • Medical records (clinic notes, procedure reports, test results, etc.) relevant to study participation or eligibility determination
   • Participant eligibility review and confirmation
   • Study treatment records – physician orders/prescriptions, drug dispensing and compliance records
   • Checklists, flow sheets, or other forms that capture source data
   • Medical history, adverse events, and concomitant medication logs
     • study staff should review concomitant medications with participants at each visit, and update the medication log as appropriate
     • PI or qualified medically trained Sub-Investigator should assess AE’s and show timely assessment with signature and date
   • Laboratory reports – documentation of study samples should include date and time of collection, and details of storage and shipment. Laboratory results from all available reports during participation should be assessed and signed/dated by the PI or medically qualified sub-investigator, and should include assessment of clinical significance for abnormal results
   • Radiologic imaging and diagnostic reports such as CT, MRI, PET, DEXA scans, x-rays, and ECGs (all ECGs during participation should be assessed by the PI or a medically qualified sub-investigator for clinical significance, signed and dated)
   • Questionnaires and participant diaries
   • Participant specific report forms submitted to the IRB- including the full report form, IRB acknowledgement letter, attachments submitted with the report form and any pertinent communication with the sponsor, CRO, PI, IRB and/or participant
   • SAE documentation, including SAE report to sponsor and confirmation of submission and receipt in timely manner, as required by the protocol
   • Notes, memoranda and communications
     
     
2. Regulatory Binder/Trial Master File should include (but is not limited to) the following documents, when applicable:
   • IRB approvals: including the initial study application and all subsequent Amendments, Continuing Reviews, and Report Forms; documentation should include the IRB correspondence letter and printed application
   • Ancillary committee approvals
   • Current and previous versions of all documents approved by the IRB, including:
     • Study Protocol
     • Informed Consent Form / Parental Permission / Assent Form
     • Investigator’s Brochure
     • Participant Recruitment Materials
     • Questionnaires
   • Form FDA-1572, or Investigator Agreement for device studies – original and all subsequent versions
   • Study/Protocol training records for PI and study staff at the beginning of the study as well as for each protocol amendment
   • Delegation of Authority log
   • Curriculum vitae - required from the PI and all personnel listed on the delegation of authority (DOA) log, at time of addition to DOA (i.e., “start date”). One-time collection will be sufficient to demonstrate qualifications and experience.
   • Medical licenses
   • Financial disclosure
   • Laboratory accreditation and reference ranges
   • Screening and enrollment logs
   • IRB membership and statement of compliance
   • Drug or Device shipping and accountability records