Which document shows the IRB/IEC is constituted in accordance with GCP?

Which document shows the IRB/IEC is constituted in accordance with GCP?

• A. IRB/IEC Composition
• B. Dated, Documented Approval/Favorable Opinion of IRB/IEC
• C. Sample of Labels Attached to Investigational Product Containers
• D. Instructions for Handling of Investigational Products and Trial-Related Materials

Answer: (A)

Showing that the IRB/IEC is constituted in accordance with GCP is evidenced by the IRB/IEC Composition. This document lists the members, their qualifications, and affiliations, confirming the committee has the appropriate mix of expertise and independence required by GCP. It demonstrates that the IRB/IEC is formed and maintained in a way that supports ethical review and protection of participants. The other documents pertain to decisions or handling of the trial materials rather than how the IRB/IEC is formed, so they don’t prove proper constitution.

Showing that the IRB/IEC is constituted in accordance with GCP is evidenced by the IRB/IEC Composition. This document lists the members, their qualifications, and affiliations, confirming the committee has the appropriate mix of expertise and independence required by GCP. It demonstrates that the IRB/IEC is formed and maintained in a way that supports ethical review and protection of participants. The other documents pertain to decisions or handling of the trial materials rather than how the IRB/IEC is formed, so they don’t prove proper constitution.