Information Sheet, Guidance for Sponsors, Clinical Investigators, and Irbs Frequently Asked Questions - Statement of Investigator (Form FDA 1572) is a 17-page legal document that was released by the U.S. Department of Health and Human Services - U.S. Food and Drug Administration on May 1, 2010 and used nation-wide.
Q: What is Form FDA 1572?
A: Form FDA 1572 is a statement of the investigator that provides essential information about the clinical trial and the investigator's qualifications.
Q: Who needs to complete Form FDA 1572?
A: The clinical investigator who is responsible for conducting the clinical trial needs to complete Form FDA 1572.
Q: What information is required on Form FDA 1572?
A: Form FDA 1572 requires information such as the name and address of the investigator, the name and address of the clinical trial site, and a list of the qualifications of the investigator.
Q: Why is Form FDA 1572 important?
A: Form FDA 1572 is important because it helps the FDA evaluate the qualifications of the investigator and ensure the integrity of the clinical trial data.
Q: When should Form FDA 1572 be completed?
A: Form FDA 1572 should be completed and signed by the investigator before the initiation of the clinical trial.
Form Details:
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