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(352) 392-1235
5/30/2010
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Contract and Grants Expenditure & Close-Out Policy
For Industry Sponsored Clinical Trials
(For C & G Accounting Staff Guidance)

  1. C&G is responsible for reconciling cash (i.e., determining that the budget released equals cash/revenue received) and running appropriate queries to document such.
  2. All Expense to Revenue (E2Rs) transactions between 2 clinical trials will be executed by C&G.;
  3. Upon request to close a clinical trial, C&G will complete the Fixed Price Close-out Memo and submit to the requestor (Dept).
  4. PI/Dept will review, comment, correct, complete and return the close-out memo to C&G.
  5. C&G will submit close-out memo to DSR’s Award Administration for approval.
  6. DSR upon approval will return close-out memo to C&G.
  7. C&G will then move the residual in accordance with the close-out memo.


Contract and Grants Expenditure & Close-Out Policy
For Industry Sponsored Clinical Trials
(For Department Guidance)

  1. Federal Cost Accounting Standards are not applicable for non-federal, industry clinical trials.
  2. Department/College Responsibility: The Department/College, with the assistance of C&G, is responsible for ensuring that all money has been collected from the Sponsor, that all outstanding bills are paid, and that all trial expenses are appropriate and attributable to the respective trial, have been posted to the project using correct account codes with appropriate back-up before project end date and before submitting a signed Closeout Memo. If additional time is needed to prepare the project for closeout, the department will request a non-protocol NO Cost Extension from DSR. Follow the below guidance specifically for all Patient Care Costs:
    1. Patient Care Costs: Send reconciled patient care service documentation/tracking to the RAC per Clinical Trials Office guidelines before sending a signed Closeout Memo.
    2. Patient care costs for a study must be paid from that same study funds. Borrowing from a Miscellaneous Donors project or overhead to pay for patient care costs is allowed, but E to E transfers must be completed for tracking purposes prior to the project end date.
  3. Justification must be provided by PI for residual funds greater than $10,000 or 25% of direct costs and approval granted by the department chair or other higher level manager to assure all infrastructure costs have been paid for.
  4. Administrative costs are expected and allowable by definition of conducting a clinical trial.
  5. Unless specifically restricted by the sponsor, normal and reasonable expenditures, including administrative costs for the clinical trial project are allowed. The PI is ultimately accountable for all expenditures.
  6. If a close-out is being delayed over any issue DSR will be notified and will assist in finding a resolution.

Contracts and Grants
PO Box 113001
123 Grinter Hall
Gainesville, FL 32611-3001
Map to Grinter Hall
Phone: (352) 392-1235
Fax: (352) 846-0137
Reviewed: 05/03/2010
Active Browsers: 32