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Should the Institutional Review Board (IRB) submission be done at the time of application?

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Should the Institutional Review Board (IRB) submission be done at the time of application?

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IRB submission is not required at the time of application. However, IRB submission–pending or approved–at the time of application would be needed for a clinical study scheduled to occur during the first year of the program. Under this circumstance, protocol and informed consent review may be provided by the NHLBI-constituted Peer Review Group rather than the NHLBI SCCT Protocol Review Committee (PRC). An IRB-approved clinical study acceptable to the Peer Review Group will, however, require SCCT Steering Committee and NHLBI SCCT Data and Safety Monitoring Board (DSMB) approval before the trial can be instituted.

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