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

The requirement for filing FDA Form 1571 is crucial before an investigational product can be shipped to an investigator. This form serves as the Investigational New Drug (IND) application and is essential for obtaining permission from the FDA to begin a clinical trial. It contains vital information about the investigational product, including its chemistry, manufacturing, and control, as well as the proposed clinical study protocol, which outlines how the research will be conducted.

Submission of the FDA Form 1571 indicates that the sponsor has navigated preliminary steps such as ensuring proper study design, safety assessments, and regulatory compliance. It also shows that the sponsor has made the necessary disclosures to the FDA about the investigational product and its intended use in human subjects. Once this form is approved, the investigational product can be shipped for clinical trials, as it assures that the study adheres to Good Clinical Practice (GCP) regulations and that participant safety is prioritized.

Although other documents, such as IRB approval, clinical trial agreements, and investigational product dossiers, play significant roles in the clinical trial process, they do not act as direct prerequisites for the shipment of the investigational product. Each of these documents serves its purpose at different stages of the clinical trial process but does