What is the sponsor's responsibility regarding site access for monitoring, auditing, and inspection?

• A. Deny access to external auditors
• B. Limit access to only the primary site
• C. Access is optional and determined case-by-case
• D. Secure agreement from all involved parties to ensure direct access to all trial-related sites, source data/documents, and reports

Answer: (D)

Direct access for oversight activities must be arranged. The sponsor is responsible for ensuring that monitors, auditors, and regulatory inspectors have direct access to all trial-related sites, source data and documents, and trial records. This access is not optional and applies to every site involved in the study, not just the primary location. To make this possible, there must be an agreement with all involved parties (investigators, sites, and institutions) confirming their obligation to allow such access. This arrangement supports verification of data accuracy, protocol compliance, and overall GCP adherence.