SOCRA CCRP Practice Exam 2025 - Free CCRP Practice Questions and Study Guide

The correct answer is rooted in the specific regulatory framework established by the FDA, particularly pertaining to clinical trials and the associated protocols.

21 CFR 312.53(c)(3) specifically addresses the requirements for Investigational New Drug (IND) applications and outlines the contents that must be included within a clinical trial protocol. This regulation mandates that a protocol must contain sufficient information to ensure the safety of participants and the scientific validity of the study. It details aspects such as study design, objectives, safety assessments, and monitoring requirements, all crucial components to ensure ethical conduct and compliance with federal regulations.

Understanding this regulation is essential for clinical researchers as it outlines their responsibilities in designing trials that are both effective in answering the research question and protective of participant welfare. This guidance is fundamental for compliance with regulatory standards during the entire process of clinical research.

The other options refer to different regulations or guidelines that, while important, do not solely govern the complete contents of a clinical trial protocol in the same specific manner as the aforementioned regulation. For instance, 21 CFR 50.25 pertains to informed consent requirements, ICH GCP provides overarching principles for good clinical practice but lacks detail on protocol content itself, and 21 CFR 56.115 deals with institutional review board (