Which items should the sponsor obtain to confirm IRB/IEC review and operation?

• A. The investigator's CV and references
• B. The name and address of the investigator's/institution's IRB/IEC and a statement that it operates according to GCP and applicable laws
• C. A copy of the budget
• D. The recruitment posters

Answer: (B)

Verifying that there is proper ethical oversight and regulatory compliance for the study. The sponsor needs to know exactly which board is reviewing the study and that it is functioning under GCP and the relevant laws. Having the name and address of the investigator’s/institution’s IRB/IEC shows which board is responsible, and a statement that it operates according to GCP and applicable laws confirms it is following the required standards for ethical review and participant protection. This combination ensures the study has valid IRB/IEC review and ongoing oversight.

The other items don’t establish that oversight: the investigator’s CV doesn’t prove IRB review, a budget is financial, and recruitment posters require IRB review but don’t confirm the IRB’s identity or compliance status.