Good Clinical Practice (GCP) Practice Exam

The correct answer is the group that includes investigators, sponsors, or regulatory authorities because these parties have a legitimate interest in ensuring that clinical trials are conducted in accordance with ethical standards and regulatory requirements.

Investigators need access to written procedures and membership lists of the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) to understand the framework within which ethical oversight is being conducted. This ensures that they are aware of the review processes applied to their studies, which helps maintain the integrity of the research and protects the rights and welfare of participants.

Sponsors also require this information as part of their responsibility to oversee the conduct of clinical trials effectively. They need to ensure that the IRB/IEC has appropriately qualified members and follows established procedures, as this can impact the trial's compliance with Good Clinical Practice (GCP) standards. Being aware of the membership and operational procedures of the IRB/IEC allows sponsors to evaluate oversight quality.

Regulatory authorities are tasked with ensuring public safety and compliance with regulations. They may request this information during audits or inspections to assess the ethical conduct of studies. Having access to written procedures and membership lists allows them to verify that proper ethical review processes are in place.

Thus, the collective entitlement of investigators, sponsors, and regulatory