Frequently Asked Questions-Statement of Investigator (Form FDA 1572) (Revision 1); Draft Information Sheet Guidance for Sponsors, Clinical Investigators, and Institutional Review Boards; Availability

概要

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of 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).'' This draft guidance partially revises the final information sheet guidance for sponsors, clinical investigators, and IRBs entitled ``Frequently Asked Questions-- Statement of Investigator (Form FDA 1572)'' (May 2010) (the Form FDA 1572 FAQ Guidance) to explain FDA's current thinking regarding waivers of the signature requirement for Form FDA 1572. This draft guidance proposes to revise responses to frequently asked questions 10, 11, and 13 from the Form FDA 1572 FAQ Guidance by including information regarding the waiver of the Form FDA 1572 signature requirement and proposes a new section regarding signature waivers.