Considerations When Transfering Clinical Investigation Oversight to Another irb

ADDITIONAL QUESTIONS ABOUT TRANSFERRING OVERSIGHT OF A 

CLINICAL INVESTIGATION ................................................................................................. 13

 

 

 

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Contains Nonbinding Recommendations 

 

 

1 

Guidance for IRBs, Clinical Investigators and Sponsors

1

 

Considerations When Transferring Clinical Investigation Oversight 

to Another IRB 

 

 

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic.  It 

does not create or confer any rights for or on any person and does not operate to bind FDA or the public.  

You can use an alternative approach if the approach satisfies the requirements of the applicable statutes 

and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for 

implementing this guidance.  If you cannot identify the appropriate FDA staff, call the appropriate 

number listed on the title page of this guidance.