3.13 Use of Placebo or Wash-Out of Effective Therapy in Clinical Trials

Last Revised: 2/7/2018

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for IRB review and approval of clinical trials that utilize placebos or wash-out of effective therapy.


2.0 Policy


3.0 Definition


4.0 Ethical Justification


5.0 Study Design Considerations



DOCUMENT HISTORY:

 Written: 1/12/2016 (Approved: 1/12/2016) - original author not recorded

 Revised: 2/7/2018 - revisions not documented


Revision #7
Created 24 October 2019 21:33:54 by Autumn M Eberly
Updated 17 April 2025 15:58:09 by Robert A Lewis