In May 2021, the U.S. Food and Drug Administration (FDA) published a draft guidance (Draft Guidance) addressing the requirement for all investigators involved in clinical trials conducted under a U.S. Investigational New Drug (IND) application to sign Form FDA 1572. This includes investigators in clinical trial sites outside the U.S.
By signing Form FDA 1572 (Form 1572), the investigator of a drug or biologic trial warrants that they and any listed staff have the experience and background needed to conduct the trial and agrees to comply with the protocol and all applicable U.S. regulatory provisions governing the conduct of clinical trials. From an FDA standpoint, it provides a clear basis of responsibility (and potential liability) under the applicable clinical trial regulations (21 CFR 312) for those who sign the form. It also raises questions about the extent of FDA’s extraterritorial reach over non-U.S. investigators who conduct IND studies outside of the United States.