What should sponsors ensure regarding IRB/IEC submissions?

• A. The submission includes the protocol version number only.
• B. The submission includes the name and address of the relevant IRB/IEC and a statement of its compliance with GCP.
• C. The submission includes patient medical histories.
• D. The submission includes the sponsor's financial disclosure.

Answer: (B)

The key idea is that the ethics review depends on knowing exactly which independent review body will assess the study and that this body operates under Good Clinical Practice. Therefore the sponsor must include identifying details of the IRB/IEC (its name and address) and a statement that this IRB/IEC complies with GCP. This confirms the proper, qualified oversight for the protocol.

Including only the protocol version doesn’t provide the necessary oversight by a recognized review body. Patient medical histories are confidential and not appropriate for initial IRB submission. Financial disclosures pertain to conflicts of interest and are not the fundamental information the IRB needs to confirm GCP-compliant ethical review.