Information Sheet, Guidance for Sponsors, Clinical Investigators, and Irbs Frequently Asked Questions - Statement of Investigator (Form FDA 1572)

Information Sheet, Guidance for Sponsors, Clinical Investigators, and Irbs Frequently Asked Questions - Statement of Investigator (Form FDA 1572) is a 13-page legal document that was released by the U.S. Department of Health and Human Services - U.S. Food and Drug Administration on July 1, 2008 and used nation-wide.

FAQ

Q: What is the Form FDA 1572?
A: The Form FDA 1572 is a document used by Clinical Investigators to provide information about themselves and their qualifications.

Q: Who needs to complete the Form FDA 1572?
A: Clinical Investigators who will be conducting a clinical trial or study are required to complete the Form FDA 1572.

Q: What information is required on the Form FDA 1572?
A: The Form FDA 1572 requires information such as the Clinical Investigator's name, address, qualifications, and the title of the study or trial.

Q: Why is the Form FDA 1572 important?
A: The Form FDA 1572 is important because it provides the FDA with information about the Clinical Investigator and helps ensure the integrity of clinical trial data.

Q: Is the Form FDA 1572 submitted to the FDA?
A: No, the completed Form FDA 1572 is not submitted to the FDA. However, it should be readily available for inspection if requested by the FDA.

Q: Are there any updates or changes that need to be reported on the Form FDA 1572?
A: Yes, any updates or changes to the information provided on the Form FDA 1572 must be promptly reported to the sponsor and the IRB.

Q: Can the Form FDA 1572 be signed electronically?
A: Yes, the Form FDA 1572 can be signed electronically as long as it meets the requirements for electronic signatures as outlined in FDA regulations.

Q: What happens if the Clinical Investigator refuses to sign the Form FDA 1572?
A: If a Clinical Investigator refuses to sign the Form FDA 1572, they may not be allowed to participate in the clinical trial or study.