What is a 1572?
The Statement of Investigator, Form FDA 1572 (1572), is an agreement signed by the. investigator to provide certain information to the sponsor and assure that he/she will. comply with FDA regulations related to the conduct of a clinical investigation of an.Click to see full answer. Also to know is, what is the 1572 form?The Statement…
The Statement of Investigator, Form FDA 1572 (1572), is an agreement signed by the. investigator to provide certain information to the sponsor and assure that he/she will. comply with FDA regulations related to the conduct of a clinical investigation of an.Click to see full answer. Also to know is, what is the 1572 form?The Statement of Investigator (Form FDA 1572) is a form that is required to be filled for clinical trials involving investigational drugs or biologics.Also Know, should study coordinators be on the 1572? The FAQ states that study coordinators should “usually be listed in Section #6 of the 1572.” This is a significant change from the July 2008 draft FAQ. Many sites do not list study coordinators on the FDA 1572, which means that most coordinators will need to file financial disclosure information. Similarly, you may ask, who needs to be on a 1572? As commonly used, the term is meant to indicate that each co-investigator is fully responsible for fulfilling all of the obligations of an investigator as identified in 21 CFR 312.60. Thus under 21 CFR 312.3(b), each co- investigator is an investigator, and as such must sign a separate Form FDA 1572.What is a 1571?(Form FDA 1571). Purpose. An Investigational New Drug Application (IND) is a request for Food and Drug Administration (FDA) authorization to administer an investigational drug to humans.
