Record Storage and Access

Abstract

The principal investigator of an FDA-regulated clinical trial must retain the administrative and clinical records pertaining to the study for one of the following periods, whichever is shortest: (1) a period of two years following the date on which the test article is approved by the FDA for marketing for the purposes that were the subject of the investigation; (2) a period of five years following the date on which the results of the investigation are submitted to the FDA in support of, or as part of, an application for a research or marketing permit for the test article for the purposes studied in the investigation; (3) in other situations (e.g., where the investigation does not result in the submission of the data from the investigation in support of, or as part of, an application for a research or marketing permit), a period of two years following the date on which the entire clinical investigation (not merely the investigator’s portion of an investigation involving more than one investigator) is completed, terminated, or discontinued, or the exemption (IND) under which the investigation is being conducted is terminated or withdrawn by the FDA.¹