Certified Clinical Research Associate (CCRA) Practice Exam

Which document is essential for reporting protocols and amendments to the FDA post-IND approval?

1. Investigator's Brochure

2. Form FDA 1572

3. Clinical trial protocol

4. Cover letter

The correct answer is: Clinical trial protocol

The clinical trial protocol is essential for reporting protocols and amendments to the FDA after Investigational New Drug (IND) approval. This document outlines the objectives, design, methodology, statistical considerations, and organization of the trial. It serves as a comprehensive guide to the study, detailing how the research will be conducted and ensuring that all team members and regulatory bodies are aligned on the study's procedures and objectives. When changes to the trial design or procedures arise, those modifications need to be documented as amendments to the clinical trial protocol. Submitting these amendments to the FDA is critical to maintaining compliance with regulatory requirements and ensuring the safety and efficacy of the investigational drug being studied. This ongoing communication is crucial for protecting participants and preserving the integrity of the trial. While the Investigator's Brochure provides valuable information about the investigational product to investigators, it does not serve the same regulatory function as the clinical trial protocol in terms of formal amendments. Form FDA 1572 pertains to the commitments of investigators conducting clinical studies and the cover letter is often used for communication purposes but does not contain protocol-specific information.