How long does a sponsor need to retain records according to FDA regulations for investigational drugs?

The correct response reflects the requirement set forth by FDA regulations regarding the retention of records for investigational drugs. Sponsors are mandated to retain records for at least two years following the date of approval of the marketing application. This period allows for the availability of information necessary for understanding the conduct and results of the study, as well as ensuring compliance with regulatory obligations.

This retention period is crucial, as it provides time for any potential audits or reviews that regulatory agencies might perform to verify that the studies were conducted in accordance with Good Clinical Practice (GCP) regulations and to ensure that data integrity is maintained.

In contrast, other options specify retention durations that do not align with FDA requirements. One year after approval and three years after trial completion do not meet the minimum duration required by the FDA, which is specifically focused on two years post-approval. The option suggesting five years after the first shipment may apply in other contexts but does not align with the FDA's protocols for investigational drug records. Thus, retaining records for two years after marketing application approval effectively meets the regulatory expectations for accountability and traceability in clinical research.