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Sponsor – CRO communication critical to IRB transfer; FDA

13-Jun-2012

Clear communication between sponsors, CROs and regulators is critical to the smooth transfer of IRB responsibilities, the FDA said.

Draft guidance from the US Food and Drug Administration (FDA) calls on all parties to maintain open dialogue when transferring oversight from one institutional review board (IRB) to another. Failing to do so can impact on the smooth running of a clinical trial.

In some situations, a transfer may disrupt study enrolment or other aspects of a clinical investigation, whether because of unforeseen difficulties in the transfer process or because of concerns arising from the study”, the FDA wrote in draft guidance on transferring IRB oversight .

The FDA draft guidance places the burden of telling the CRO (contract research organisation), data safety monitoring board, and other entities linked to the clinical investigation, on the study sponsor.

So the FDA can access records quickly openness must also extend to the agency. “It is important for the agency to know which entity (eg the original IRB, the receiving IRB, the institution that housed the original IRB, a CRO or other responsible third party) will maintain the records”, the FDA wrote.

The need for communication is lessened when clinical trial oversight is transferring between IRBs at the same institution. In these instances the FDA expects “simpler and more expeditious” transfers that can exclude some of the precautionary measures needed when moving to a separate IRB.

Timelines for transfers are also affected by the number and risk of the studies being moved, as well as the reasons for making the switch, with some motivations carrying greater legal, regulatory, administrative, and logistical burdens than others.

Transfer of IRB oversight due to purely administrative reasons such as consolidating IRB workload may be straight-forward, whereas a transfer of oversight due to the original IRB’s non-compliance would be anticipated to be more lengthy and involved”, the FDA wrote.

IRB warning letter

This week the FDA also hit the IRB Advocate Health Care with a warning letter criticising its informed consent process in a clinical trial, submitted to ClinicalTrials.gov in 2007 , run by the hospital in which it is based.

The IRB approved Study 4257, a clinical investigation for which informed consent was not sought from prospective subjects or their legally authorised representatives, without satisfying the requirements for approving such an investigation”, the FDA wrote in its warning letter .

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