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

The choice of regulation that outlines the roles and responsibilities of a sponsor is indeed found in 21 CFR 312.50. This regulation is part of the FDA's guidelines regarding Investigational New Drugs (IND). Specifically, it details the general responsibilities of sponsors in the conduct of clinical investigations, including the obligation to ensure that there are adequate resources for the investigation, adherence to regulations, and compliance with the Institutional Review Board (IRB) requirements.

Understanding 21 CFR 312.50 is crucial for clinical research professionals, as it emphasizes the importance of the sponsor's role in the oversight and administration of clinical trials, ensuring participant safety and regulatory compliance. The regulation also highlights the requirement for sponsors to report adverse events and to maintain accurate records, reinforcing the ethical considerations in human subject research.

The other options refer to different regulations within the FDA's framework. 21 CFR 312.30 covers the general requirements for IND application submissions, 21 CFR 812.40 relates to the responsibilities and requirements for sponsors of Investigational Device Exemptions (IDE), and 21 CFR 314.50 pertains to NDA (New Drug Application) submissions. While all these regulations are essential in the context of drug and device development, they do not specifically address