Good Clinical Practice (GCP) Practice Exam

Who is primarily responsible for requesting records from the IRB?

1. Funding agencies

2. Clinical trial sponsors

3. Investigators only

4. They are not required to request records

The correct answer is: Clinical trial sponsors

The primary responsibility for requesting records from the Institutional Review Board (IRB) typically lies with clinical trial sponsors. Sponsors are the entities that oversee the development and conduct of the clinical trial, which includes ensuring that all regulatory obligations, including IRB interactions, are properly fulfilled. They must ensure that the IRB has reviewed and approved the study protocol and any associated documents to protect the rights and welfare of the participants. Sponsors often require access to IRB records to verify compliance with regulatory requirements and to maintain oversight of the trial's ethical conduct. This information is crucial for monitoring the trial, addressing any issues that arise, and ensuring the overall integrity of the research. Investigators also play a role in the process, as they may request records related to their specific studies, but they do so typically under the direction or on behalf of the sponsor. Funding agencies might have a vested interest in the study's outcomes and compliance, but they do not directly request IRB records. Also, stating that records are not required to be requested misrepresents the necessity of having proper oversight in clinical research. Therefore, the emphasis on clinical trial sponsors as the primary requestors aligns with the regulatory framework established for conducting human subject research and ensuring ethical standards are met.