Good Clinical Practice (GCP) Practice Exam

What is one requirement for an IRB's continuing review process?

1. At least one researcher must be present

2. Written records of minutes must be kept

3. All members must be enrolled in the trial

4. Decisions must be made by consensus

The correct answer is: Written records of minutes must be kept

The requirement for an Institutional Review Board (IRB) to maintain written records of minutes is critical for several reasons. Keeping written minutes is essential for transparency and accountability in the IRB’s review process. It ensures that there is a permanent record of what was discussed, decisions made, and the rationale behind those decisions during the continuing review process. This documentation provides a clear historical context for the IRB's actions, which is important for regulatory compliance and audits. These records also serve to protect the rights and welfare of participants by ensuring that the IRB is adhering to protocols and regulatory guidelines. In contrast, while having at least one researcher present at an IRB meeting could facilitate discussion, it is not specifically mandated as a requirement for continuing review. The involvement of all members in the trial is also not necessary for continuing review, and decision-making by consensus is not a strict requirement; IRBs can function by majority vote, with the need for a quorum being the defining feature for a valid review process.