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Human Subjects Division (HSD)

Documents

Document Details

Last Updated 05/07/2013
Version 3.60
Filesize 192.5 KB
Audiences Researcher
Doc Type Form

Report of Other Problems

Purpose

This form is for reporting unanticipated problems, protocol violations and deviations.

Related Documents

Change Notes

  • Related to Ver. 3.60, noted 05/07/2013 @ 07:09pm
    Updated instructions.
    - sherrye
  • Related to Ver. 3.50, noted 08/17/2012 @ 02:23pm
    Added FDA Regulated Y/N in HSD office use only box.
    - sherrye
  • Related to Ver. 3.31, noted 10/06/2011 @ 05:15pm
    Fixed typo in footer date - that is the only change okay to use earlier dated forms.
    - sherrye
  • Related to Ver. 3.30, noted 05/27/2011 @ 09:10am
    Addition of double-sided copy instructions.
    - sherrye
  • Related to Ver. 3.20, noted 09/30/2010 @ 09:11am
    The section on Data and Safety Monitoring Reports has been removed. The single location for describing the DSM report is now section "N" of the Modification Form.
    - sherrye
  • Related to Ver. 3.10, noted 09/16/2010 @ 01:42pm
    Updated document links.
    - sherrye
  • Related to Ver. 2.20, noted 08/17/2010 @ 02:59pm
    Report of Other Problems is now a stand-alone form. Changes have been made to reflect that, including the addition of a cover page, and separation from the Modification Form
    - sherrye