Emergency Use of FDA-Regulated Test Articles- PRO151   

 

 

Abstract: 
This procedure outlines the responsibilities of the investigator, OIRB and IRB for emergency use of FDA-Regulated test articles. This document also includes basic elements and disclosures included in informed consent for emergency use of test articles.

Effective Date: 3/30/2007

 

Review/Revised Date: 8/14/2019

 

Category: Research

 

Policy Owner: Vice President for Research

Policy Contact:

 
   
 
 
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