Random Audit for Financial Compliance

Scheduled Audit

This type of review is considered a full audit. Focus of review includes:

• Budget determination
• Delineation of PIC and RC
• Adherence to the Medicare National Coverage Decision (NCD)
• Adherence to the UConn Health research financial policies and state laws and regulations
• Appropriate approval from Medicaid and other third party payers for payment of RC associated with a clinical trial.
• Review may also include:
  1. review of contract
  2. review of PIC paid by sponsor
  3. review of RC paid by third party payer or participant
  4. review of all patient charges/billing
  5. review of any charges/billing for adverse events
  6. review of charges billed to the study Banner account #
  7. changes in budget
  8. changes in contract

Unscheduled Audit

This type of audit is done to assess one or two elements of the full audit, such as

• Budget delineation, or
• Patient charges.

For Cause Audit for Financial Compliance

This type of audit is performed when concerns regarding research financial compliance are brought to the attention of the Office of Clinical and Translational Research (OCTR), the Human Subjects Protection Office (HSPO), Institutional Review Board (IRB) or Research Compliance.

First Subject Reconciliation

A first subject reconciliation is completed early in the trial to establish that study related transactions are happening according to plan or that problems are found early and corrective action may be taken. Areas of focus are listed below.

• Research related charges for UMG and JDH are correct, complete and reflect the proper CPT/Procedure code in accordance with the Budget Workbook.
• All start-up fees were received from the sponsor and allocated to the study Banner fund. Regular study payments are correctly recorded (if yet received).
• Study personnel have allocated proper Time & Effort via payroll distribution or through cost sharing.
• Study related charges are paid to UMG or JDH at the proper rate and discount.