Which term identifies the formal approval by the IRB to conduct the trial at the site?

• A. Audit Certificate
• B. Institutional Review Board Approval
• C. Audit Trail
• D. Audit Report

Answer: (B)

Institutional Review Board Approval is the formal authorization from the IRB that allows a site to begin and conduct a clinical trial. The IRB reviews the study protocol, informed consent documents, and risk–benefit assessment to ensure participant protections and regulatory compliance. Once the IRB grants written approval, the site can initiate the study and enroll subjects, with ongoing reviews at defined intervals to maintain approval. This term specifically denotes ethical clearance to conduct the research at the site, not monitoring or auditing activities. Audit-related terms (Audit Certificate, Audit Trail, Audit Report) refer to oversight and documentation of quality checks, not to ethical approval to conduct the trial.