Which item best demonstrates IRB/IEC compliance with GCP and applicable laws?

• A. The IRB/IEC's name and address
• B. The subject enrollment plan
• C. A statement from the IRB/IEC that it is organized and operates according to GCP and applicable laws
• D. The sponsor's license

Answer: (C)

A formal statement from the IRB/IEC that it is organized and operates in accordance with GCP and applicable laws provides direct evidence that the board has established governance, procedures, and oversight practices aligned with regulatory requirements. This declaration shows the IRB/IEC is not just a named entity but is actively structured to review, approve, and monitor studies under the protections and standards GCP demands. It addresses how the IRB maintains its independence, follows written procedures, and ensures subject rights and welfare are protected, all in line with legal and regulatory expectations.

In contrast, the IRB/IEC’s name and address are only contact information, the subject enrollment plan pertains to study conduct rather than IRB oversight, and the sponsor’s license relates to the sponsor, not the IRB’s compliance with GCP.