Considerations When Transfering Clinical Investigation Oversight to Another irb

U.S. Department of Health and Human Services 

Food and Drug Administration 

Center for Drug Evaluation and Research  

Center for Biologics Evaluation and Research 

Center for Devices and Radiological Health 

Office of Good Clinical Practice  

 May 2014 

 

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Contains Nonbinding Recommendations 

 

 

 

TABLE OF CONTENTS 

 

 

I.

 

INTRODUCTION............................................................................................................. 1

 

II.  

 

BACKGROUND ............................................................................................................... 1

 

III.