When may regulatory authorities access audit reports if not routinely requested?

• A. Only after the trial is completed.
• B. Only during routine inspections.
• C. On a case-by-case basis when evidence of serious GCP non-compliance exists, or during legal proceedings.
• D. They never have access to audit reports.

Answer: (C)

Regulators access audit reports outside routine requests only when there is a specific, justified reason tied to safety and compliance. They review such reports on a case-by-case basis when there is evidence of serious GCP non-compliance that could impact participant protection or data integrity, or during legal proceedings. This keeps sensitive audit information confidential unless there is a legitimate need to support an investigation or enforcement action. Routine inspections do not automatically entail access to all audit reports, and regulators do have a pathway to obtain them when serious issues or legal processes are involved.