Certified Clinical Research Associate (CCRA) Practice Exam 2025 – All-in-One Guide to Master Your Certification!

FORM FDA 1572 is known as the Statement of Investigator, which serves as a crucial document in the clinical research process. This form is required by the FDA for all clinical trials conducted under an Investigational New Drug (IND) application. It outlines the responsibilities of the investigator(s) and provides key information about the study, including details on the investigational product, the study protocol, and the qualifications and experience of the investigator.

The Statement of Investigator signifies the investigator's commitment to comply with the regulatory requirements, including adherence to Good Clinical Practice (GCP), ensuring the well-being of trial subjects, and accurately reporting study data. It acts as a formal acknowledgment that the investigator understands these responsibilities and is capable of conducting the study according to the approved protocol.

While the protocol of the clinical trial and the clinical trial budget estimate are important components of a clinical study, they do not specifically fulfill the role of the Statement of Investigator. Additionally, data collection forms are tools used to gather information from trial participants but are separate from the regulatory and ethical commitments outlined in FORM FDA 1572.