SOCRA CCRP Practice Exam 2025 – 400 Free Practice Questions to Pass the Exam

The correct answer is based on the role of the ICH GCP (International Council for Harmonisation Good Clinical Practice) guidelines in providing comprehensive standards and recommendations for the design, conduct, recording, and reporting of clinical trials. These guidelines specifically address protocol structure and contents, ensuring that all necessary elements are included for the proper conduct of a trial and the protection of participants.

The ICH GCP guidelines are internationally recognized and serve as a framework to bring consistency and quality across global clinical research practices. They outline the essential elements that a protocol must contain, such as objectives, methodology, statistical considerations, and ethical considerations, which are crucial for the integrity of clinical trials.

While the FDA, EPA, and CDC have important regulatory roles and provide guidance in their respective domains, the ICH GCP guidelines are the primary reference for protocol structure and content in the context of clinical research, making this the most appropriate choice.