Certified Clinical Research Associate (CCRA) Practice Exam 2025 – Complete Preparation Guide

The cover letter is a critical component of an Investigational New Drug (IND) submission as it provides an introductory overview and justification for the investigational plan. This letter offers a concise summary that outlines the purpose of the submission, highlights significant aspects of the investigational drug and study design, and presents any pertinent background information that supports the request for investigational approval.

It serves as a formal introduction to the accompanying documents, facilitating the review process by clearly stating the intent and scope of the research. While other documents included with the IND submission, such as the investigator's brochure and protocols, contain essential details and specific data about the study, they do not fulfill the role of summarizing the overall justification for conducting the clinical trial. Instead, they focus on specific aspects of the study. Meanwhile, Form FDA 1572 is required for the registration of investigator sites and personnel involved in the study but does not provide an overview of the investigational plan.