Certified Clinical Research Coordinator (CCRC) Practice Exam

In the U.S., following the ICH E6 GCP is considered:

1. Mandatory for all clinical trials

2. Voluntary for FDA-regulated drug studies

3. Compulsory for international studies only

4. Recommended but not enforced

The correct answer is: Voluntary for FDA-regulated drug studies

The correct choice reflects that adherence to ICH E6 Good Clinical Practice (GCP) guidelines is indeed voluntary for FDA-regulated drug studies. While ICH E6 GCP provides a framework for ensuring the quality and integrity of clinical trials, compliance is generally not mandated by the FDA. Instead, the guidelines serve to guide best practices in clinical research, ensuring that studies are conducted ethically and that data is reliable. In this context, researchers and organizations are encouraged to follow these guidelines to promote the protection of human subjects, but they are ultimately not legally bound to do so. As a result, many researchers opt to adhere to ICH E6 GCP to enhance the credibility of their studies and maintain ethical standards, but it remains a choice rather than a legal requirement for those conducting clinical research under FDA regulation. This understanding aligns with the principle that while international standards exist, actual enforcement and compliance may vary based on regulatory frameworks and individual circumstances. Thus, rather than being compulsory, following ICH E6 GCP in the U.S. is a matter of best practice rather than an absolute obligation.