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1.17 Retention of Research Records

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for retention of research records by the investigator.

2.0 Policy

It is the policy of the Organization that all research records must be maintained and stored securely, in accordance with Nebraska State Law, for at least seven years beyond the termination of the study or longer as required by sponsors.

3.0 Required Records

  • 3.1. The research records retained by the investigator should include the initial version as well as all amendments of the:
    • 3.1.1. IRB application
    • 3.1.2. Detailed protocol
    • 3.1.3. Grant (if applicable)
    • 3.1.4. Investigator brochure (if applicable)
    • 3.1.5. ICF(s)/Information sheet(s) (unsigned)
    • 3.1.6. Case report forms (blank)
    • 3.1.7. Applications for continuing review
    • 3.1.8. DSMB reports (if applicable)
    • 3.1.9. IND/IDE correspondence and annual reports (if applicable)
    • 3.1.10. Requests for change
    • 3.1.11. Adverse event reports (internal, internal fatal and external) with corresponding documentation (e.g., safety reports) and applicable consent documents
    • 3.1.12. Reports of unanticipated problems involving risk to the subject or others
    • 3.1.13. Reports of protocol deviations
    • 3.1.14. Reports of noncompliance.
    • 3.1.15. Reports of Audits and Post-Approval Monitoring
    • 3.1.16. Correspondence between the IRB and the PI (or research staff)
    • 3.1.17. Correspondence from the Sponsor, including contracts, MTAs, and DUAs.
    • 3.1.18. For research conducted outside the Organization where the UNMC IRB is the IRB of record, documentation of training in the protection of human subjects by external investigators or staff, external investigator agreements, and other contractual agreements
    • 3.1.19. Any other protocol-related documentation
    • 3.1.20. Subject files including original signed consent documents, case report forms (CRFs), laboratory results and other applicable information.
  • 3.2. For applications and reports generated within RSS (for example, the IRB Application, Request for Change, Continuing Review, Report of Protocol Deviation), a paper copy may be printed an retained as above, or the presence of the information within RSS constitutes “retention” of the record for the purpose of this policy.

4.0 Department Retention of Records

  • 4.1. If the PI resigns or otherwise departs from the Organization before the end of the designated retention period, the department of record must maintain the research records unless otherwise specified.
  • 4.2. The PI may request a copy of the research records in accordance with applicable Organizational policies

ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 FEBRUARY 18, 2019

 REVISED FEBRUARY 2, 2018

 INITIAL DECEMBER 28, 2015 (ORIGINAL POLICY #3.5)

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