Which term best describes the process of performing a formal review to ensure compliance with the protocol and SOPs?

• A. Audit Trail
• B. Audit
• C. Blinding/Masking
• D. ADR

Answer: (B)

Audits are formal, independent reviews of trial activities and records to verify that everything complies with the protocol, SOPs, and applicable regulations. They involve examining source documents, consent forms, training records, and procedures to determine conformity and identify deviations or areas for corrective action. This is distinct from an audit trail, which is the chronological record of data entries and changes showing who did what, used for traceability rather than as a review process. Blinding/masking relates to concealing treatment assignment to reduce bias, and ADR refers to an adverse drug reaction, a safety event, not a review of compliance. So the process described is an audit.