Use of and Investigation with Drugs, Biologics, Devices, or Test Articles under FDA Regulations- POL021   

 

 

Abstract: 
Clinical investigations involving human subjects and drugs, biologics, devices or test articles are subject to review. In order to comply with federal regulations, the IRB will determine what types of applications and exemptions (when applicable) are required for the study. This document describes various types of studies and instructions for submission and compliance.

Effective Date: 3/30/2007

 

Review/Revised Date: 2/21/2018

 

Category: Research

 

Policy Owner: Vice President for Research

Policy Contact:

 
   
 
 
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