Which entity does the Form FDA 1572, Statement of Investigator, create a legal agreement between the investigator and?

The Form FDA 1572, known as the Statement of Investigator, creates a legal agreement between the investigator and the FDA. This form is essential in the context of clinical trials as it outlines the responsibilities and commitments of the investigator, including adherence to Good Clinical Practice (GCP) regulations, oversight of the study, and compliance with federal regulations.

When an investigator signs the FDA 1572, they are affirming their understanding of the study protocol and their obligations as they relate to the FDA’s requirements. This includes ensuring the safety and rights of participants and maintaining the integrity of the data collected during the trial. By doing so, the investigator enters into a binding agreement with the FDA, which establishes the regulatory framework within which the study must be conducted.

While the investigator is also responsible to subjects, the IRB, and the sponsor of the study, the legal relationship established specifically through the signing of Form FDA 1572 is with the FDA, making them the correct entity related to this document.