Which item should the sponsor obtain from the IRB/IEC to confirm GCP compliance?

• A. The IRB/IEC's tax ID
• B. A statement from the IRB/IEC that it is organized and operates according to GCP and applicable laws
• C. The protocol version
• D. The recruitment materials

Answer: (B)

The idea being tested is that a sponsor needs formal assurance from the IRB/IEC that it is organized and operating in line with GCP and applicable laws. A written statement from the IRB/IEC affirming its organization and compliance provides clear, auditable evidence that ethical and regulatory oversight is in place for the trial. This helps ensure that the IRB/IEC is functioning properly and that its reviews meet GCP standards, which is essential for the trial’s integrity and regulatory acceptance.

Other items don’t serve this purpose: a tax ID shows legal identity but not GCP compliance; the protocol version reflects which protocol is current but not the IRB’s adherence to GCP; recruitment materials pertain to approved content but not the IRB’s compliance status.