Which statement best describes sponsor responsibilities related to direct access to source data for monitoring and regulatory inspections?

• A. It should be specified in the protocol or written agreement and includes access to source data/documents
• B. It is optional and not documented
• C. Access is limited to anonymized data
• D. Access is prohibited to protect privacy

Answer: (A)

Direct access to source data by monitors and regulatory inspectors is a sponsor responsibility that must be defined up front. The sponsor is responsible for ensuring that those who verify trial conduct and data integrity—such as monitors and inspectors—can review the original records and source documents, not just the data entered into the case report forms. This access needs to be specified in the protocol or a written agreement so everyone understands the scope, methods, and limits of the review, and so inspections can be conducted smoothly and in compliance with GCP and regulations. This arrangement supports accurate data verification, proper confirmation of eligibility and consent, and overall trial integrity.

Access to anonymized data or prohibiting access would undermine the ability to verify data against the actual source records, and is not consistent with sponsor responsibilities. Privacy protections should be in place, but they do not eliminate the requirement for direct access to source data for monitoring and inspections.