6.5 Expanded Access to Investigational Drugs and Devices for Treatment Use

1.0 Purpose


2.0 Policy


3.0 Definitions


4.0 General Considerations


5.0 Investigator procedures


6.0. IRB / ORA procedures


7.0 Informed Consent


DOCUMENT HISTORY:

 Written: 1/18/2021 (Approved: 1/18/2021) - original author not recorded

 Revised 1/23/2024 – added information regarding continuing review for expanded access protocols (section 6.6){Approved Russell McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}


Revision #5
Created 27 January 2021 16:03:32 by Autumn M Eberly
Updated 31 July 2024 19:31:21 by Robert A Lewis