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Human Subjects Division (HSD)


Document Details

Last Updated 02/17/2015
Version 1.30
Filesize 80.61 KB
Audiences HSD Staff, IRB Member, Researcher
Doc Type Policy

SOP Reporting by Researchers


This document describes the information and events that must be reported to the Human Subjects Division (HSD), as well as the time frame and procedures for the reporting.

Change Notes

  • Related to Ver. 1.30, noted 02/17/2015 @ 09:54am
    Changed \"problem\" to \"information or event\" in 3.1.3.
    - sherrye
  • Related to Ver. 1.20, noted 11/26/2014 @ 12:03pm
    Added references to the updated PAVE reporting processes.
    - sherrye
  • Related to Ver. 1.20, noted 08/29/2014 @ 10:19am
    Updated definitions to be in line with the Human Subjects Assistance Program.
    - sherrye
  • Related to Ver. 1.10, noted 05/12/2014 @ 10:34am
    Updated Study Monitor to Safety Monitor, 2.1.15
    - sherrye
  • Related to Ver. 1.00, noted 02/28/2014 @ 09:20am
    Document newly added.
    - sherrye