What statement best describes the purpose of direct access to source data and documents in GCP inspections?

• A. To allow only the sponsor access to data
• B. To permit altering source data during inspection
• C. To ensure data are anonymized before inspection
• D. To permit trial-related monitoring, audits, IRB/IEC reviews, and regulatory inspections with direct access to source data/documents

Answer: (D)

Direct access to source data and documents is needed so those overseeing the trial can verify the accuracy and integrity of the data and ensure adherence to the protocol and GCP. Inspectors, monitors, IRB/IEC members, and regulatory authorities must be able to review original records (such as source documents and consent forms) to confirm that what’s reported matches what happened in the study, that participants were properly consented, and that the trial was conducted according to approved procedures. This access supports trustworthy data and proper conduct, not modification of data during inspection. While patient confidentiality is important and data may be handled with appropriate protections, the purpose of direct access is to enable correct verification of trial activities and records.