What should be maintained by the IRB/IEC as part of its records?

What should be maintained by the IRB/IEC as part of its records?

• A. A list of IRB/IEC members and their qualifications
• B. The sponsor's organizational chart
• C. The participants' medical histories
• D. The trial budget

Answer: (A)

The key idea is that the IRB/IEC must keep a roster of its members along with their qualifications. This shows there is appropriate expertise and independence to review trial protocols, consent documents, and risk–benefit assessments, and it supports regulatory compliance and auditability. Having current information on who serves, each member’s qualifications, and any potential conflicts helps verify that decisions were made by qualified individuals and with proper oversight. The sponsor’s organizational chart, participants’ medical histories, and the trial budget aren’t required IRB records; those belong to sponsor management, confidential participant data, or financial documentation, respectively, and aren’t part of the IRB’s mandated records.

The key idea is that the IRB/IEC must keep a roster of its members along with their qualifications. This shows there is appropriate expertise and independence to review trial protocols, consent documents, and risk–benefit assessments, and it supports regulatory compliance and auditability. Having current information on who serves, each member’s qualifications, and any potential conflicts helps verify that decisions were made by qualified individuals and with proper oversight. The sponsor’s organizational chart, participants’ medical histories, and the trial budget aren’t required IRB records; those belong to sponsor management, confidential participant data, or financial documentation, respectively, and aren’t part of the IRB’s mandated records.