Direct Access to Source Records enables which activity?

• A. It permits the public to audit source documents.
• B. It requires de-identification before access.
• C. It allows authorized personnel to verify data against original records.
• D. It enables automated data deletion by sponsors.

Answer: (C)

Direct Access to Source Records means that those conducting the trial—such as monitors, auditors, and authorized sponsor representatives—may review the original source documents that support the data entered on the case report forms. This access is essential for data verification, allowing authorized personnel to confirm that what is reported matches the patient’s actual records (medical charts, lab results, etc.). It ensures data integrity and traceability, showing who reviewed what and when. Public access is not appropriate due to privacy and confidentiality protections. De-identification before access isn’t the goal here, because the purpose is to verify accuracy against identifiable source records; data used for reporting outside the site should still be handled per privacy rules. Automated data deletion by sponsors would undermine data integrity and regulatory compliance and is not part of this process.