Which term describes a systematic and independent examination of trial related activities and documents to determine whether they were conducted and the data were recorded, analyzed and accurately reported according to the protocol, sponsor's SOPs, GCP, and applicable regulatory requirements?

Which term describes a systematic and independent examination of trial related activities and documents to determine whether they were conducted and the data were recorded, analyzed and accurately reported according to the protocol, sponsor's SOPs, GCP, and applicable regulatory requirements?

• A. Audit
• B. Audit Trail
• C. Audit Report
• D. Audit Certificate

Answer: (A)

An audit is a formal, independent examination of trial-related activities and records to assess whether they were conducted and whether data were recorded, analyzed, and reported in accordance with the protocol, sponsor SOPs, GCP, and applicable regulatory requirements. This description highlights the objective, systematic approach and independence needed to gather evidence, verify compliance, and ensure data integrity, while identifying deviations for corrective actions. The other terms refer to parts or outcomes of that process—an audit trail is the log of data changes, an audit report is the document that communicates findings, and an audit certificate is a credential confirming the audit was completed.

An audit is a formal, independent examination of trial-related activities and records to assess whether they were conducted and whether data were recorded, analyzed, and reported in accordance with the protocol, sponsor SOPs, GCP, and applicable regulatory requirements. This description highlights the objective, systematic approach and independence needed to gather evidence, verify compliance, and ensure data integrity, while identifying deviations for corrective actions. The other terms refer to parts or outcomes of that process—an audit trail is the log of data changes, an audit report is the document that communicates findings, and an audit certificate is a credential confirming the audit was completed.