Certified Clinical Research Coordinator (CCRC) Practice Exam

To whom do the standards described in ICH E6 GCP apply?

1. Only to clinical researchers

2. Investigators, sponsors, and IRBs

3. Patients and study subjects

4. Government regulatory bodies

The correct answer is: Investigators, sponsors, and IRBs

The standards described in ICH E6 GCP (International Conference on Harmonisation Good Clinical Practice) apply to investigators, sponsors, and Institutional Review Boards (IRBs). This set of guidelines is designed to ensure that clinical trials are conducted ethically and that the rights, safety, and well-being of study participants are protected. Investigators are responsible for conducting the trial and ensuring adherence to the protocol and regulatory requirements. Sponsors are typically organizations or individuals who initiate and manage the clinical trial, motivating them to ensure that the study is conducted according to GCP standards. IRBs play a critical role in approving the trial protocol and overseeing all trial-related activities to ensure that ethical considerations are met. Thus, compliance with these guidelines is a collective responsibility involving all these parties, which underscores the collaborative nature of conducting ethical science in clinical research. The focus is not solely on researchers or specific regulatory bodies, but rather on a broader network that includes multiple stakeholders in the clinical trial process.