After completion or termination, which set of documents should be retained?

• A. Only the sponsor's mailing list
• B. The sponsor's internal memos
• C. All documents required for trial closure
• D. Consent forms only

Answer: (C)

After completion or termination, you keep the full set of documents needed to close out the trial and to reconstruct how the trial was conducted, ensuring data integrity and participant protection can be demonstrated to inspectors or regulators. This includes the protocol and any amendments, ethics approval, informed consent forms and any re-consents, subject enrollment and retention logs, source documents, case report forms, data management and statistical plans, monitoring and QA reports, safety and adverse event documentation, regulatory correspondence, the final study report, and trial-related training records. Keeping these materials together provides a complete, auditable trail showing that the trial was conducted in accordance with GCP and applicable laws, and that participant rights and safety were protected.

Retention periods depend on local laws, sponsor requirements, and the nature of the product, but the principle remains: hold onto these essential documents for the legally required duration after the last subject’s participation or after regulatory approval. Shorter retention or omitting key documents would leave an incomplete record and hinder any future verification or audits.