Which term is the affirmative decision of the IRB that the trial may be conducted at the site within constraints?

• A. Audit
• B. Blinding/Masking
• C. Audit Certificate
• D. Institutional Review Board Approval

Answer: (D)

The fundamental idea is that a study cannot start at a site until the IRB has given formal permission to conduct it under the approved terms. The correct term is Institutional Review Board Approval. This represents the formal clearance from the IRB after they’ve reviewed the protocol, the informed consent documents, recruitment plans, and measures to protect participants’ rights and welfare. It confirms the study may proceed at the site within the specified constraints (approved protocol, consent language, privacy protections, risk minimization) and may include conditions the investigators must meet. Without this approval, the trial cannot be initiated or continued under GCP and regulatory rules. The other options aren’t about granting permission to conduct the study: an audit is a separate compliance review, blinding/masking is a methodological technique, and an audit certificate isn’t a standard term in this context.