1.16 ORA Record Keeping Requirements

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for maintenance of documentation of IRB and ORA activities.

2.0 Policy

It is the policy of the Organization that the ORA will maintain documentation of all IRB activities in accordance with 45 CFR 46.115 and 21 CFR 56.115 as applicable. Records for each protocol will be organized to allow a reconstruction of a complete history of all IRB actions related to the review and approval of the protocol.

3.0 Procedures

  • 3.1. Format of Protocol Files:
    Protocol files may be either in paper or electronic format. The format is dependent upon the year of initial review, the type of review, and the current status of the study.
    • 3.1.1. In general, research initially reviewed by the full IRB after January 16, 2012 is in electronic format accessed through RSS, and research initially reviewed by the full IRB prior and closed prior to January 16, 2012 is in paper files. Research initially reviewed by the full IRB prior to January 16, 2012 and either still active, or closed after that date may be partially in paper format and partially in electronic format.
  • 3.2. Requirements for maintenance of protocol files: Each protocol file will include:
    • 3.2.1. The submitted IRB application which must contain all information necessary for the Board to make all the determinations required by 45 CFR 46.111 and 21 CFR 56.111.
    • 3.2.2. Detailed protocol (if required)
    • 3.2.3. Investigators Brochure (if required)
    • 3.2.4. Federal grant applications (if required)
    • 3.2.5. ICF/information sheets (if required). HIPAA authorization are included in this document as per HRPP policy 5.1 (Obtaining Informed Consent from Research Subjects).
    • 3.2.6. Documentation of scientific and scholarly merit review and approval of proposals by the Fred & Pamela Buffett Cancer Center Scientific Review Committee (SRC) for cancer-related studies.
    • 3.2.7. Documentation of review and approval of proposals by the Pharmacy and Therapeutics Committee (P&T Committee) (if required).
    • 3.2.8. Documentation of review and approval by the Institutional Biosafety Committee (IBC) (if required).
    • 3.2.9. Copies of Clinical Trial Master Matrix and Coverage Analysis findings (if required).
    • 3.2.10. Copies of any written reviews from consultants.
    • 3.2.11. Review letters to the PI. Review letters include determinations in accordance with HRPP policy that the research satisfies, as applicable, all requirements of the following:
      • Subparts of 45 CFR 46 (Subparts B, C, and D)
      • 21 CFR 50 (Subpart D)
      • Categories under which research is approved under expedited review
      • Waiver or alteration of informed consent under applicable HHS regulations
      • Waiver or alteration of HIPAA authorization under 45 CFR 164.512
      • Waiver of documentation of consent under applicable HHS and FDA regulations.
      • The category of research approved as exempt in accordance with HHS and FDA regulations.
        Note: The basis upon which the IRB determined that the specific findings required by applicable HHS and FDA regulations were met is found in the specific IRB application that was reviewed.
    • 3.2.12. PI responses to review letters and any other IRB correspondence to PIs.
    • 3.2.13. Documentation of approval of recruitment materials and copies of the approval materials.
    • 3.2.14. Requests for Change and correspondence pertaining to the request, including copies of the modified IRB approved and stamped ICF(s)/information sheets and/or protocols associated with the request.
    • 3.2.15. Copies of any new significant information provided to subjects.
    • 3.2.16. Applications for Continuing Review and correspondence pertaining to the request, including copies of the ICF(s)/information sheets approved in conjunction with continuing review.
    • 3.2.17. Interim progress reports and Data Safety Monitoring Board (DSMB) reports.
    • 3.2.18. Reports of Internal adverse events and adverse device effects.
    • 3.2.19. Reports of any non-physical injury to a subject.
    • 3.2.20. Reports of unanticipated problems involving risk to the subject or others
    • 3.2.21. Significant new findings provided by the investigator or discovered through other means.
    • 3.2.22. Requests for Single subject protocol deviations and violations.
    • 3.2.23. Reports of Protocol Violations
    • 3.2.24. Reports of Subject complaints
    • 3.2.25. Reports of incidents of noncompliance, including documentation of investigation, correspondence, and reports to institutional officials, OHRP, and FDA where appropriate.
    • 3.2.26. Results from Post Approval Monitoring reviews and correspondence regarding the findings.
    • 3.2.27. IRB Review Checklists documenting:
      • The justification for using the expedited review procedure.
      • The rational for conducting continuing review of research that otherwise would not require continuing review.
      • The rational for a determination that research appearing on the list of eligible expedited review categories is greater than minimal risk.
      • Actions taken by the reviewer.
      • Any documentation for determinations and justifications required by laws, regulations, codes, and guidance
      • Exempt determinations
  • 3.3. Long-Term Record Storage
    • 3.3.1. Paper copies of protocol records of non-exempt research are maintained in UNMC storage in either CD-ROM (prior to 2012) or paper format (after 2012). CD-ROM discs or hard copy will be stored indefinitely for future reference or inspection by HHS, FDA or other sponsor representatives.
    • 3.3.2. All protocol submitted electronically through RSS (after 2012) are maintained indefinitely in RSS for future reference or inspection by HHS, FDA, or other sponsor representatives.
  • 3.4. UNMC Research Administration Database:
    • 3.4.1. The ORA maintains a password protected database with full access by all members of the ORA. The database includes the characteristics of the research including the classification of the research, the study population, the designated risk level, type of review, funding source, and other information necessary to allow the IRB staff to track and monitor the status of protocols, (for example, IRB approval periods), and perform searches in order to produce reports.
    • 3.4.2. The database is available in “view” mode to selected groups outside of the ORA (for example, Sponsored Programs Administration and the P&T Committee) to assist those groups in their roles in the HRPP.
  • 3.5. IRB Agendas, Meeting Minutes, and Membership Rosters:
    Copies of all IRB agendas, minutes, IRB member Curriculum Vitae, and IRB membership rosters are maintained electronically within the ORA.
  • 3.6. IRB Educational Items:
    Copies of all educational items given to the IRB members and ORA Staff are maintained in the ORA, either in paper or electronic format.
  • 3.7. HRPP Policies and Procedures:
    Copies of HRPP policies and procedures as required by 45 CFR 46.115 and 21 CFR 56.115 are maintained on the IRB website, in RSS and in hardcopy.
  • 3.8. Availability of IRB records:
    All IRB records are accessible for inspection and copying at reasonable times and in a reasonable manner in accordance with 45 CFR 46.115 and 21 CFR 56.115.