Who should retain sponsor-specific essential documents pertaining to the trial?

• A. The sponsor.
• B. The sponsor's data owner.
• C. The sponsor or other owners of the data.
• D. The clinical site.

Answer: (C)

In GCP, documents that reflect the sponsor’s governance and responsibility for the trial are kept by the entity that owns the data or is sponsoring the study. The sponsor or, if the data are owned by someone else (for example, a data owner or a contract research organization acting as custodian), that owner becomes the custodian of those sponsor-specific essential documents. This ensures regulators and monitors can access the sponsor-level records regardless of where the trial activities occur. The clinical site, by contrast, holds documents related to site conduct, not sponsor governance.