Research Record Storage, Retention and Disposition

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Storage, Retention and Disposition Requirements

Data Retention When Subjects Withdraw From Research

 

Storage, Retention and Disposition Requirements

The Space@UCSF page has information on research record storage and data retention at UCSF. The UC Office of the President has policies on research record management, including requirements for human subjects research studies. The Administrative Records Related to Research: Retention and Disposition Requirements matrix summarizes these requirements.

Data Retention When Subjects Withdraw From Research

Guidance differs based on whether the study is regulated by the FDA and/or DHHS

FDA-Regulated Research: FDA published guidance on requirements for retention of data by clinical investigators in studies regulated by FDA. The guidance focuses on what data must be retained by the investigator when a subject withdraws from a study and what data an investigator may continue to obtain when a subject withdraws from a study.

Note that the FDA’s guidance differs from DHHS guidance, discussed below. In brief, FDA states that:

  • When a subject withdraws from a study, the investigator may not remove data from the study database that has already been collected on that subject;
  • The researcher may ask the withdrawing subject to allow the researcher to obtain follow-up data through non-invasive means such as chart review. In this case, the investigator may continue to obtain data as agreed by the subject;
  • If the subject does not agree to continued follow-up, then the investigator must not access the subject’s records for purposes of the research study once the subject has withdrawn. The investigator may, however, review data already collected and may review publicly available records to obtain data on the subject (e.g., for survival status).

DHHS-Regulated Research: The U.S. Department of Health and Human Services (DHHS) issued its own guidance on data retention when subjects withdraw from a study. As noted above, the DHHS guidance differs from the FDA’s guidance in that the DHHS states that when a subject withdraws from a study, the investigator may honor the subject’s wishes to remove all data collected from the study database.