On 20 May 2021, the FDA released a draft information sheet guidance for sponsors, clinical investigators, and institutional review boards (IRBs) entitled “Frequently Asked Questions—Statement of Investigator (Form FDA 1572) (Revision 1).” The guidance draft proposes to revise responses to the following frequently asked questions from the Form FDA 1572 FAQ Guidance:
- Question 10: Must investigators who conduct studies outside the United States sign a 1572?
- Question 11: If a foreign clinical study is being conducted under an IND [investigational new drug application], what are the investigator’s responsibilities with respect to regional, national, or local laws and regulations?
- Question 13: If a sponsor chooses to conduct a foreign clinical study under an IND and the investigators at the non-U.S. sites follow the recommendations in the [International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use] ICH E6 Good Clinical Practice Consolidated Guidance, would the non-U.S. investigators also be in compliance with FDA’s IND requirements under 21 CFR part 312?
