- Docket Number:
- Issued by:
Guidance Issuing OfficeOffice 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 This pertains to data from individuals who decide to discontinue participation in a study, who are withdrawn by their legally authorized representative, as applicable, or who are discontinued from participation by the clinical investigator.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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2008-D-0576.