What is the purpose of Form FDA 1572, Statement of Investigator?

Form FDA 1572, known as the Statement of Investigator, serves as a legally binding agreement between the investigator and the FDA. This form is integral in clinical trials, as it confirms that the investigator understands their responsibilities, including compliance with Good Clinical Practice (GCP) regulations, oversight of the study, and reporting of adverse events. By signing this document, the investigator commits to adhering to the protocol, protecting the rights and welfare of study participants, and following all applicable regulatory requirements.

The need for this agreement ensures that there is clarity regarding the investigator's role in the study and establishes a formal record of the investigator's commitment to conducting the research in accordance with federal guidelines. The FDA relies on this form to ensure that investigators are properly qualified and that they understand their obligations regarding the conduct of clinical trials.