Maintaining Participant Records

Definition

• Maintaining participant records includes reviewing and updating documents of individuals who are taking part in the study.

Policies/procedures/guidelines/processes

• Sponsors expect the study team to maintain participant records and capture data as described in the research plan and to meet regulatory responsibilities.
• UMMC’s Record Retention Policy, which includes provisions for ownership of data, requires the retention of study records in accordance with regulatory, organizational, and sponsor or grantor requirements, but no less than six years following completion of the research.
  • The following summarizes a few of the more common regulatory requirements:
    • OHRP – research records must be retained for at least three years after the completion of the research
    • HIPAA – Research authorizations, or documentation of waivers or alterations of authorization, must be held for a minimum of six years after the authorization or waiver/alterations was last obtained or in effect, whichever is later
    • FDA – Drugs (and biologics classified as drugs) - For a period of two years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the application is not approved for such indication, until two years after the investigation is discontinued and FDA is notified
    • FDA – Devices (and biologics classified as devices) - For a period of two years after the latter of the following two dates: The date on which the investigation is terminated or completed, or the date that the records are no longer required for purposes of supporting a pre-market approval application or a notice of completion of a product development protocol.