FDA Guidance for the Industry

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Information Sheet Guidance for Sponsors, Clinical Investigators (CIs), 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.

This guidance applies to clinical investigations conducted under 21 CFR Part 312 (Investigational New Drug Applications or IND regulations). It describes how to complete the Statement of Investigator form (Form FDA 1572).

The Food and Drug Administration (FDA or agency) has received a number of questions about Form FDA 1572.

The most frequently asked questions are answered in the following guidance below (downloadable in PDF).

If you do not see your question answered in the guidance, you may submit it to gcp.questions@fda.hhs.gov or druginfo@fda.hhs.gov.

Download FDA Guidance in PDF

Download “Information sheet for sponsor IRBs CIs” UCM214282.pdf – Downloaded 443 times – 105 KB

Last Updated: 2016-04-05

FDA Guidance for Sponsors CIs IRBs and Form FDA 1572
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