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Human Subjects Division (HSD)

Documents

Document Details

Last Updated 06/05/2014
Version 2.00
Filesize 1.78 MB
Audiences Researcher
Doc Type Form
Use of HSD PDF Forms

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WORKSHEET: Case Report

Purpose

Information collected and presented on one or more individuals to highlight an interesting experience, observation, treatment, presentation, relationship or outcome. It typically (but not always) results from a retrospective review of the individual's record. It may, alternatively, involve a prospective intervention or prospective collection of specimens or data that is not part of standard service or care.

This is a self-determination process.  Answer the questions in the sequence listed, the print the completed form and keep it with your records. Use this form (with your answers) and a copy of the flow chart called Case Report: IRB and HIPAA Requirements (linked below) for documentation that IRB review and approval of your case report was not required. If you are not sure about whether your case report is research, email this completed form with a brief description of your activity (no more than 1/2 page) to hsdinfo@uw.edu, asking for a research determination.

Change Notes

  • Related to Ver. 2.00, noted 06/05/2014 @ 05:30pm
    Updated to PDF, and to include more information on HIPAA and PHI.
    - sherrye
  • Related to Ver. 1.20, noted 10/19/2013 @ 05:00pm
    Updated name to new naming convention on website.
    - sherrye
  • Related to Ver. 1.20, noted 06/28/2013 @ 10:51am
    Modified question 2 to reflect new SOPs. Do not use previous versions.
    - sherrye
  • Related to Ver. 1.10, noted 12/06/2010 @ 08:50am
    Fixed error in branching logic on question 1.
    - sherrye
  • Related to Ver. 1.00, noted 12/01/2010 @ 11:51am
    Document newly added.
    - sherrye