Should records identifying the subject be kept confidential and identity remain confidential when results are published?

• A. Direct access to the subject's original medical records by monitors, auditors, IRB/IEC and regulatory authorities is allowed for verification, with confidentiality maintained.
• B. Records will be publicly available with identity.
• C. Only physician notes will be shared.
• D. All information will be publicly posted.

Answer: (A)

Maintaining participant privacy while allowing verification of study data is essential. In GCP, authorized individuals such as monitors, auditors, IRBs/IEC, and regulatory authorities may access source documents to verify that the data reported in the study are accurate and complete. This access is permissible only if confidentiality protections are in place, meaning identifiable information is safeguarded and disclosed only to those with legitimate, approved need to review it. When results are published, identities should remain confidential or be de-identified, so publication does not reveal who participated.

This option correctly captures both the need for proper verification of records and the obligation to keep participants’ identities confidential. The other choices imply exposing identities publicly or sharing only partial notes, which would violate privacy protections and the ethical and regulatory standards that govern clinical research.