What must the sponsor verify regarding a subject's consent for direct access to original medical records?

• A. Written consent by the subject for direct access to records
• B. Verbal consent is sufficient
• C. Consent from a guardian is sufficient for adults
• D. No consent is required

Answer: (A)

Direct access to a subject’s original medical records must be supported by explicit, documented permission from the subject. Written consent provides a tangible record of who may access the records, what records may be accessed, and for what purpose, helping protect privacy and meet regulatory requirements. Verbal consent isn’t enough because it can’t be verified or audited after the fact. For adults, a guardian’s permission is only appropriate if the subject cannot consent for themselves; otherwise the subject’s own written authorization is needed. Accessing records without consent would violate confidentiality and GCP standards. So, the sponsor verifies that there is written consent from the subject authorizing direct access to their records.