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Human Subjects Division (HSD)


Document Details

Last Updated 08/13/2015
Version 2.00
Filesize 84.53 KB
Audiences HSD Staff, IRB Member, Researcher
Doc Type Policy

SOP FDA-Regulated Research


This document describes the requirements and procedures for research that is subject to the regulations of the Food and Drug Administration (FDA).

Change Notes

  • Related to Ver. 1.20, noted 04/15/2015 @ 09:17am
    Updated to reflect new criteria for what is FDA regulated research.
    - sherrye
  • Related to Ver. 1.10, noted 11/22/2013 @ 10:51am
    Added When the UW is involved in conducting only some components of an FDA regulated study, critera for when the research activities do not meet the FDA\'s definition of human subjects research.
    - sherrye
  • Related to Ver. 1.00, noted 11/01/2013 @ 11:35am
    Document newly added.
    - sherrye