Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

According to GCP requirements, who should make the decision about the suitability of subjects participating in a trial?

1. The sponsor

2. The investigator

3. The regulatory authority

4. The ethics committee

The correct answer is: The investigator

The investigator plays a crucial role in determining the suitability of subjects participating in a clinical trial, in accordance with Good Clinical Practice (GCP) requirements. This responsibility is grounded in the investigator's comprehensive understanding of the study protocol, the specific inclusion and exclusion criteria set forth, and the ethical considerations involved in patient recruitment. The investigator is directly involved in assessing potential participants' medical histories, current health status, and other important factors that may impact their eligibility for the trial. This ensures that the rights, safety, and well-being of the subjects are prioritized, as the investigator is responsible for obtaining informed consent and monitoring the safety of participants throughout the study. While the sponsor may provide overall guidance and the regulatory authority may set the framework for compliance and safety, it is ultimately the investigator who has the direct interaction and relationship with trial subjects and is best positioned to make this individualized assessment. The ethics committee also plays a role in the approval of protocols and oversight but does not make individual subject suitability decisions.