Good Clinical Practice (GCP) Practice Exam

What is retained by the IRB beyond the trial for regulatory compliance?

1. Clinical trial results

2. Membership lists and procedures

3. Investigator qualifications

4. Patient consent forms

The correct answer is: Membership lists and procedures

The institutional review board (IRB) has a critical role in ensuring the protection of the rights and welfare of human subjects involved in clinical trials. One of the key responsibilities of the IRB is to maintain certain documentation beyond the duration of the trial to ensure ongoing compliance with regulatory requirements. Retaining membership lists and procedures allows the IRB to demonstrate that it is composed of qualified individuals as mandated by regulations. This includes documenting the expertise of its members, their roles, and how decisions are made. This information is essential not only for transparency but also for the integrity of the review process. By retaining such records, the IRB can provide regulatory authorities with evidence that it complies with the necessary guidelines concerning its composition and procedural integrity. On the other hand, clinical trial results, investigator qualifications, and patient consent forms may not be retained permanently by the IRB in the same way, although they are essential documents for the conduct of the trial itself. For instance, while patient consent forms are crucial for tracking participant consent and ethics throughout the study, they typically do not need long-term retention by the IRB once the trial is complete and findings are reported. Similarly, although investigator qualifications are vital for initial approval, the IRB's primary ongoing documentation concern is maintaining