Considerations When Transfering Clinical Investigation Oversight to Another irb

clinical investigation(s). 

 

FDA recommends establishing a transfer date for each clinical investigation, including records, 

for which oversight is being transferred.  Although there is no regulatory requirement to establish 

a transfer date, such an action promotes continuity, helps prevent a lapse in IRB coverage, and 

minimizes confusion regarding which IRB is responsible for review and action if an 

unanticipated problem should arise or if the clinical investigation needs to be quickly suspended 

or terminated.  When choosing a transfer date, the affected IRBs should allow enough time for 

all appropriate actions, communications, and agreements to occur.   

 

Depending on the circumstances of the transfer, the transfer date may be established using one of 

a variety of methods, such as the following: 

 

•

 

In the written agreement, the exact date is specified in advance between the original IRB 

and the receiving IRB; or 

•

 

In the written agreement, the date is made contingent upon the review and acceptance of 

the clinical investigation by the receiving IRB.  For example, if the receiving IRB decides 

to perform an initial review of the clinical investigation, the transfer may take effect on 

the date the receiving IRB makes its decision to approve, require modification in (to 

secure approval), or disapprove the clinical investigation.  In this situation, the receiving 

IRB should notify the original IRB and other involved parties of the date of its approval 

and acceptance of oversight responsibilities. 

 

Note that if both the original and receiving IRBs are located within the same institution, the 

transfer date may be determined according to the established procedures of that institution.   

 

                                                 

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 Factors to consider in selecting an appropriate record retention arrangement may include the reasons for the 

transfer, as well as the nature of the clinical investigations and the records.  Generally speaking, and depending on 

the specific facts, FDA would expect an IRB that has accepted record keeping responsibilities to retain the 

documentation for at least 3 years after closure of the IRB, in accordance with 21 CFR 56.115(b), or transfer the 

records to the receiving IRB. 

 

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