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Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials Guidance for Sponsors, Clinical Investigators, and IRBs October 2008

Issued by:
Guidance Issuing Office
Office of the Commissioner,Office of Clinical Policy and Programs,Office of Clinical Policy,Office of Good Clinical Practice

This guidance is intended for sponsors, clinical investigators and institutional review boards (IRBs). It describes the Food and Drug Administration’s (FDA) longstanding policy that already-accrued data, relating to individuals who cease participating in a study, are to be maintained as part of the study data. This pertains to data from individuals who decide to discontinue participation in a study, who are withdrawn by their legally authorized representative, as applicable, or who are discontinued from participation by the clinical investigator. This policy is supported by the statutes and regulations administered by FDA as well as ethical and quality standards applicable to clinical research. Maintenance of these records includes, as with all study records, safeguarding the privacy and confidentiality of the subject’s information.

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

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