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Human Subjects Division (HSD)

Documents

Document Details

Last Updated 11/22/2013
Version 1.10
Filesize 86.06 KB
Audiences HSD Staff, IRB Member, Researcher
Doc Type Policy

SOP FDA-Regulated Research

Purpose

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. 1.10, noted 11/22/2013 @ 10:51am
    Added 2.1.2.10 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