What must be specified in the protocol regarding access to source data and documents?

• A. Monitoring, audits, IRB/IEC review, and regulatory inspections with direct access to source data/documents
• B. Access is provided only to designated statisticians
• C. Access is allowed only after study ends
• D. Access to anonymized data only

Answer: (A)

In clinical trials, the protocol must specify who has access to source data and source documents and under what circumstances. This is essential to support ongoing verification of data integrity and participant safety. Specifically, access should cover those involved in monitoring, audits, IRB/IEC reviews, and regulatory inspections, with the understanding that they may have direct access to source data and documents as needed to confirm consent, eligibility, adverse events, data accuracy, and overall compliance with the protocol and GCP. While safeguards for privacy and confidentiality apply, limiting access only to statisticians, granting access only after the study ends, or restricting access to anonymized data would impede necessary oversight and verification.