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Human Subjects Division (HSD)


Document Details

Last Updated 02/28/2014
Version 1.00
Filesize 70.42 KB
Audiences HSD Staff, IRB Member, Researcher
Doc Type Policy

SOP Expanded Access


This document describes the IRB related requirements and procedures for the mechanisms that allow expanded access to investigational drugs, devices, and biologics for clinical (not research) purposes before the items have been approved by the Food and Drug Administration (FDA) for use and marketing.

Change Notes

  • Related to Ver. 1.00, noted 02/28/2014 @ 08:50am
    Document newly added.
    - sherrye