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Human Subjects Division (HSD)

Documents

Document Details

Last Updated 02/28/2014
Version 1.00
Filesize 61.43 KB
Audiences HSD Staff, IRB Member, Researcher
Doc Type Policy

SOP Single Patient Emergency Use

Purpose

This document describes the policies and summarizes the procedures associated with the emergency use of an investigational item regulated by the Food and Drug Administration (FDA) for clinical purposes with a single patient.

Change Notes

  • Related to Ver. 1.00, noted 02/28/2014 @ 08:52am
    Document newly added.
    - sherrye