UW Directories | Calendar | Map | MyUW
UW logo
Skip to Main
Human Subjects Division (HSD)

Documents

Document Details

Last Updated 09/26/2014
Version 2.00
Filesize 2.14 MB
Audiences HSD Staff, IRB Member
Doc Type Form
Use of HSD PDF Forms

HSD Forms are compatible with Adobe Reader, Version 10 and higher, though we recommend use of the most recent version. You may receive messages from Adobe to upgrade.

For Mac users: be sure to open the form in Adobe Reader or Acrobat.

download Adobe Reader

WORKSHEET: Device Risk Determination

Purpose

This worksheet is used as guidance to facilitate the IRB's determination about the risk level of an investigational device. The IRB follows the procedures described in the SOP FDA-Regulated Research.

Change Notes

  • Related to Ver. 2.00, noted 09/26/2014 @ 11:26am
    This checklist has been converted to an optional worksheet.
    - sherrye
  • Related to Ver. 1.00, noted 11/01/2013 @ 11:54am
    Document newly added.
    - sherrye