Which entity should retain sponsor-specific essential documents related to the trial?

• A. The site.
• B. Regulatory authorities.
• C. The sponsor or other owners of the data.
• D. The participants.

Answer: (C)

The key idea is that sponsor-specific essential documents are owned by the sponsor or the owners of the data and must be kept by them for the trial. These documents prove the trial was conducted according to the protocol and GCP, and they support the integrity and traceability of the data. Because the sponsor owns the data and is ultimately responsible for regulatory compliance and audit readiness, retaining the sponsor’s TMF (or its equivalent) falls under the sponsor’s responsibility. This includes documents that reflect the sponsor’s decisions, data handling, trial oversight, and statistical analyses.

The site maintains its own set of site-specific essential documents to show proper conduct at the investigative site, but those are distinct from the sponsor’s documents. Regulatory authorities may review copies as part of inspections, and participants have their own consent-related records, but sponsor-specific documents belong with the sponsor or the sponsor’s data owners.