Introduction to GCP Requirements and the Informed Consent Process In the context of clinical research, especially for US-based clinical trials, the informed consent process is a critical component that ensures the protection of participants and the integrity of study data. Adherence to Good Clinical Practice (GCP) requirements as specified in 21 CFR Part 50, 21 CFR Part 54, 21 CFR Part 56, and 21 CFR Part 312 is essential for compliance with both the FDA and the Office for Human Research Protections (OHRP). The informed consent process involves providing potential participants with essential information about a clinical trial to make…