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Human Subjects Division (HSD)


Document Details

Last Updated 10/17/2014
Version 1.10
Filesize 61.53 KB
Audiences HSD Staff, HSD Staff, IRB Member, IRB Member, Researcher, Researcher
Doc Type Policy

SOP Single Patient Emergency Use


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. 1.10, noted 10/17/2014 @ 09:35am
    Added instructions to see DORA manual for data entry procedures.
    - sherrye
  • Related to Ver. 1.00, noted 02/28/2014 @ 08:52am
    Document newly added.
    - sherrye