Good Clinical Practice (GCP) Practice Exam

Which of the following is NOT a required document for IRB records?

1. Minutes of meetings

2. Participant demographic information

3. Membership lists

4. Correspondence

The correct answer is: Participant demographic information

In the context of Institutional Review Board (IRB) records, participant demographic information is not classified as a required document. The primary purpose of the IRB is to protect the rights and welfare of human subjects participating in research, and its records are focused on the oversight and ethical review processes involved in studies. The minutes of meetings serve as an official record of the IRB's discussions and decisions, ensuring transparency and accountability in reviewing research protocols. Membership lists are essential for maintaining the integrity of the board’s composition, ensuring that members possess the necessary qualifications and diversity to review the research ethically. Correspondence, such as communications with investigators and regulatory bodies, is also critical for documenting the IRB's interactions and decisions. In contrast, while collecting demographic information from participants is crucial for research purposes, it is not specifically categorized under the documents necessary for maintaining IRB records. This distinction highlights the focus of the IRB on procedural and administrative aspects rather than participant-specific data, which is typically handled by the research team.