For how long are investigative sites expected to keep all study records?

The expectation for investigative sites to maintain all study records is primarily determined by regulatory guidelines and the agreement between the site and the sponsor. Keeping records until the sponsor allows destruction is founded on the necessity for documentation to be available in case of inquiries, audits, or regulatory reviews that might occur after a trial concludes. This practice ensures compliance with Good Clinical Practice (GCP) and regulatory authorities' requirements, which generally stipulate that records must be retained for a period defined by the sponsor or governing regulations, typically until there is resolution regarding the study's integrity and findings.

Retaining records until the sponsor's authorization to destroy them safeguards the availability of crucial data that may be required to verify results, address any post-study issues, or fulfill regulatory obligations. Additionally, it adheres to various guidelines, including those from the FDA and ICH, which underscore the importance of maintaining sufficient documentation throughout the duration necessary for regulatory compliance and accountability.

Other options, while they may address certain aspects of record retention, do not encapsulate the complete requirement as clearly as the correct answer. Certain time frames mentioned do not account for the discretion of the sponsor, while indefinite retention can lead to logistical challenges and is rare unless mandated by other laws. Completing a regulatory review may not encompass all