Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs; Frequently Asked Questions-Statement of Investigator (Form FDA 1572); Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of an information sheet guidance entitled, "Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs; Frequently Asked Questions--Statement of Investigator (Form FDA 1572)." This guidance is intended to assist sponsors, clinical investigators, and institutional review boards (IRBs) involved in clinical investigations of investigational drugs and biologics in completing the Statement of Investigator form (Form FDA 1572). FDA developed this information sheet guidance in response to numerous questions from the research community regarding Form FDA 1572. This information sheet guidance provides FDA's responses to the most frequently asked questions.