Considerations When Transfering Clinical Investigation Oversight to Another irb

Contains Nonbinding Recommendations 

 

 

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for example, when a transfer occurs as a result of non-compliance actions of the original 

IRB.      

 

Both the original IRB and the receiving IRB should maintain adequate records regarding 

the clinical investigations affected by the transfer.

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  Such records should include:  any 

written agreement between the original and receiving IRBs; the title of the protocols 

being transferred; the expiration dates of IRB approval; the research sites affected; the 

names of the associated sponsors, clinical investigators, and CROs; the identities of the 

original IRB and the receiving IRB; and the date(s) on which the receiving IRB accepts 

responsibility for oversight of the clinical investigations.  In addition, the original and 

receiving IRBs should keep adequate records of all communications to all affected 

sponsors, clinical investigators, and FDA, and comply with all other recordkeeping 

requirements.

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