Policy & Guidance Refresher

May 2013

WITHDRAWAL OF SUBJECTS FROM FDA-REGULATED STUDIES

This guidance provides insights on how to best handle subjects who voluntarily drop-out from a clinical trial or are withdrawn from the study by the clinical investigator. It also helps to clarify FDA’s longstanding policy that data that has already been collected from subjects must be retained in the study data for the given clinical trial even if the subject voluntarily drops-out of the study. Based on the FDA’s October 2008 “Guidance for Sponsors, Clinical Investigators, and IRBs – Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials”, it provides additional guidance to the Columbia University “Informed Consent Policy”.

 

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