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Why must the Separation of Allowable Costs (SAC) be completed?

The primary objective of the SAC is to ensure that all costs of a clinical trial are billed to the appropriate payor whether it is the sponsor, a third-party payor or the patient.  Clinical research often takes place in conjunction with the routine clinical care of patients and it is necessary to ensure that billing for both routine and research services/items are handled appropriately and in compliance with all applicable statutory requirements. See our website at for more information and to view a sample SAC.

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