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    Regulatory File Checklist

    The first section of this checklist identifies items that should be included in the investigator's regulatory study file for any study. The second section of this checklist identifies those additional items required for an FDA-governed study. 
     

     

    Section 1  
    Study-specific Documents
    "X" Item Comment-Suggestions
       Protocol Original version (original signed version, if applicable).

    All amended versions, including the current IRB-approved protocol.
      Case Report Forms/research data capture forms (if applicable) Blank copy of all versions of forms.

    Maintain completed and signed copies of forms for each study subject in separate subject study file/binder.
      Informed consent documents Current IRB approved informed consent document and all versions of the informed consent document applicable to the study.

    (If applicable) Informed consent document template received from the sponsor.

    (If applicable) Current IRB approved short form – used in consenting process of non-English speaking individuals in the absence of a translated informed consent document.

    File all signed and dated informed consent documents in the research file.
      Study procedure manual Original version and any amended versions of the procedure manual.
    Correspondence
      Correspondence with sponsor (if applicable) Includes but is not limited to information such as study updates, progress reports, safety updates/reports, amendments to protocol, reports of adverse events and protocol deviations, requests for protocol exceptions.

    Includes formal letters and pertinent email messages.
      Correspondence with study monitor (if applicable) Includes, but is not limited to, monitoring visits and reports, requests for query resolution, progress reports, reports of adverse events and protocol deviations.

    Includes formal letters and pertinent email messages.
      Correspondence received from data safety monitoring board/committee (if applicable) Includes but is not limited to regularly scheduled reports and interim findings.
      Correspondence with funding agency/foundation (if applicable) Includes but is not limited to: emails with NIH program officer, annual reports to NIH, and summary reports to foundations.
      Correspondence with contracting sites/investigators (if applicable) Includes all pertinent and key communication and correspondence.
    IRB/Privacy Board Correspondence and Approvals 
      Initial submission packet Includes application form, supporting documents such as supporting grant, recruiting materials, informed consent document or request for waiver of informed consent, request for access to PHI, tools used in conduct of study (survey, questionnaire, etc.) modifications/clarifications submitted for IRB approval, and if applicable, GCRC and/or safety committee approval, IRB approval from other institution (if MCW faculty/staff are conducting study at site other than MCW/FH). 
      All correspondence received from and submitted to IRB/Privacy Board. Includes formal letters such as approval letters and pertinent email messages.
      Progress reports and associated documents All progress reports, including modifications/clarifications submitted for IRB approval, and (if applicable) progress reports submitted to the GCRC and NIH, etc.
      Amendments to protocol All amendments, including modifications/clarifications submitted for IRB approval. 
      Changes in conduct of study other than amendment to protocol. Examples include but are not limited to change in investigators or other research team members, revised or new recruiting materials.
      Serious Adverse Events (if applicable) Events meeting criteria for reporting within 72 hours and criteria for reporting at time of continuing progress report.
      Protocol deviations Deviations to protocol, which meet criteria for reporting within 72 hours and/or criteria for reporting at time of the continuing progress report.
      Final report File final report within 3 months of termination or completion of study.
    Lab Documents
      Lab certification (CLIA)(if applicable) Applicable for external lab.
      Reference lab values ---
      Curriculum vitae of lab supervisor (if applicable) Applicable for external lab.
      IATA certification for packaging and shipping human subject substance (if applicable) Applicable if packaging and shipping of human subject substance not delegated to lab personnel.
    Logs/Tracking Records
      Adverse event log ---
      Protocol deviation log ---
      Telephone log ---
      Screening logs (if applicable) ---
      Enrollment logs (if applicable) ---
      Research subject activity log (if applicable) ---
      Study staff signature log (if applicable) ---
      Delegation of duties/role and responsibilities log (if applicable) ---
      Site visit log/monitoring log (if applicable) ---
      Storage/equipment monitoring logs (if applicable) Information tracked may include but is not limited to temperature of storage area/refrigerator/freezer, calibration of centrifuge, scale, and/or blood pressure monitoring equipment, etc.
      Retained tissue log ---
    Miscellaneous
      IRB roster  Current and previous applicable rosters
      Community Review Panel roster (if applicable) Include roster(s) in study file as well as formal correspondence including approvals.
      Federal Wide Assurance (FWA)(if applicable) Current and previous applicable versions
      Audit reports (if applicable) Internal/external
      Monitoring reports (if applicable ---
      Data Safety Monitoring Plan (if applicable) Required for GCRC supported studies.
      Risk Assessment instrument (if applicable) Required for GCRC supported studies.
      Curriculum Vitae (CV) File a copy of current signed and dated CVs for all investigators (principal and co- or sub- investigator), and other study personnel as applicable.
      Study-related training records (if applicable) ---

    Section 2 
    Study-specific Documents
    Include the following items in the regulatory file for FDA-governed studies
    "X" Item Comment-Suggestions
      Documentation of IND/IDE/HDE or justification of exemption Documentation may be in the form of correspondence from the FDA or sponsor regarding the device status.
      FDA Form 1572 1572 must be signed and dated.

    Update the 1572 to reflect current investigators.

    Keep all original versions on file.
      Investigator Brochure (drug study) Current IRB approved Investigator Brochure and all previously approved versions of the Investigator Brochure applicable to the study.
      Package insert/product information (in place of Investigator Brochure) Current package insert/product information received from sponsor/manufacturer.
      Investigational Plan (device study) Current IRB approved Investigational Plan and all previously approved versions of the Investigational Plan.
      Toxicity scale ---
    Investigational Product Accountability
    Include the following items in the regulatory file for FDA-governed studies
      Investigational drug or device shipping records/receipts. Include all documents reflecting items received from sponsor/manufacturer and those returned to sponsor/manufacturer.
      Investigational drug or device dispensing/accountability records. Documentation of dispensing should be recorded in general tracking log as well as in each individual research study subject file.
      Investigational drug or device final disposition records Include all documents reflecting the product used in study, returned to sponsor/manufacturer, or destroyed.
    Miscellaneous
    Include the following items in the regulatory file for FDA-governed studies
      Queries General queries. File individual research subject queries in the research subject study file/binder.
      Professional license File a copy of the current license for all licensed professionals involved in the conduct of the study. Keep all versions on file.
     v. 06/18/07