SOCRA CCRP Practice Exam

What regulatory body offers guidance on protocol structure/contents?

1. FDA

2. EPA

3. CDC

4. ICH GCP guideline

The correct answer is: ICH GCP guideline

ICH GCP stands for International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Good Clinical Practice. It is a set of international standards and guidelines for the conduct of clinical trials. While the FDA (A), EPA (B), and CDC (C) all play important roles in regulating various aspects of drug development, they do not specifically offer guidance on protocol structure or contents. The FDA, or Food and Drug Administration, is responsible for protecting public health by ensuring the safety, efficacy, and security of drugs, medical devices, and other consumer products. The EPA, or Environmental Protection Agency, is responsible for protecting human health and the environment by enforcing regulations on pollution, waste, and chemical safety. The CDC, or Centers for Disease Control and Prevention, is responsible for protecting public health and safety by providing guidance on health and disease prevention. While all of these agencies may provide useful information for clinical