FDA Issues Draft Guidance on Signature Waiver Process for Statement of Investigator Form (Form FDA 1572) The U.S. Food and Drug Administration has issued a draft guidance for industry titled Frequently Asked Questions Statement of Investigator (Form FDA 1572). It is an update to a 2010 guidance with the same title. The guidance is intended for clinical trial sponsors, clinical investigators, institutional review boards, and other stakeholders. FDA revised the guidance to be consistent with the Form 1572 signature waiver process that the agency implemented in 2018. This process allows a sponsor to request a waiver if an investigator at a foreign clinical trial site refuses to sign the form, generally because of regional, national, or local laws or regulations prohibiting the investigator's signature. The revisions in this 2021 guidance respond to stakeholder questions about how to proceed if a foreign investigator cannot or will not sign this form. Form 1572 aims to collect investigator information at each clinical trial site. The investigator signs the form to verify that he or she has the experience and background needed to conduct the trial and that he or she will conduct it in an ethical and scientifically sound manner. This draft guidance partially revises FDA's 2010 guidance. When these revisions are finalized, FDA will incorporate them in a new information sheet guidance for sponsors, clinical investigators, and institutional review boards. | 
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