Table of Contents>Clinical Trial Residual Balance Closeout


PURPOSE
· To establish a procedure for the distribution and transfer of residual balances from industry sponsored clinical trials to a designated department fund.


POLICY STATEMENT
· RA-CLIN-001 (still pending)
Clinical Trials: Distribution of Residual Funding from Clinical Trials


REASON FOR PROCEDURE

· To close out restricted fund
· To allow department to spend unrestricted residual balance


WHO SHOULD KNOW THIS PROCEDURE

· Deans
· Center and Institute Directors
· Department Chairs
· School of Medicine Administration
· School of Medicine Faculty/Investigators
· Business Administrators
· Office of Research Support Services
· Penn Research Services


GENERAL INSTRUCTIONS

· Within 120 days of the fund account end date communicate to ORSS regarding the status of the trial:

  • If trial is complete and all cash has been received complete the Residual Balance Worksheet indicating the residual to transfer (including all signatures) and send to ORSS Post Award Grants Specialist.  ORSS reviews/approves the forms and forwards to Research Services. Research Services makes the transfer and then disables the fund.
  • If the trial is complete, but outstanding collections exist communicate to ORSS Post Award Grants Specialist when you expect to receive final payment.  The Residual Balance Worksheet can be sent to ORSS after all cash is received.
  • If the trial is not complete communicate to ORS Corp Contract Administrator and Cc ORSS Post Award Director and Post Award Grants Specialist that the trial account end date needs to be extended.

· Research Services is able to make the residual balance transfer regardless of the status of the fund. If the fund is frozen, the transfer overrides the lock on the fund.

· The residual balances are transferred to the SOM Designated Fund (014001), in each department's ORG, using the PI's CREF unless other departmental procedures exist.

· If the PI has left Penn, the residual balance or deficit will be transferred to the SOM designated account at the discretion of the chair, division chief or director.

· ORSS will provide a quarterly summary of funds that have been transferred and funds that were then disabled upon request.

· The School of Medicine will collect the active F&A rate currently being charged to the clinical trial/sponsored research agreement fund on the residual balance.

· The cash balance of the fund can be determined by calculating the total Cash Received from the Sponsor and subtracting the project to date expenditures.  This should also match the negative receivable (i.e. cash surplus) as shown on the fundsummary report in Webi.

· If you are closing out a clinical trial fund which has a deficit, you must go through the regular process for closing out a grant with your department designated research accountant.


PROCEDURES

· Once the clinical trial fund has reached its end date determine the status of the trial to be communicated to ORSS as indicated in the instructions above.  The 60 day adjustment period is available and the 120 day window to communicate to ORSS is to allow for ample time to collect all final billings even after the fund has frozen.
· If the trial is over prior to the account end date you can close the trial early if no additional payments are to be received.  The end date will be changed to the date the residual transfer is completed.
· Verify residual cash balance (use fundsummary report).
· If residual balance is greater than 50% of total award, further explanation from the Principal Investigator is required and must be included with request for transfer.
· Verify that there are no encumbrances.
· Complete both tabs of the Residual Balance Worksheet.
· Verify that all department signatures (PI, Chair and BA) are present.
· Run fundsummary report and include as backup documentation verifying the residual balance to be transferred.
· Submit to ORSS (270 Anatomy-Chemistry/6061).
· If transfer has not been made within two weeks, contact ORSS Grants Specialist.

If ORSS has not received a status communication within 120 days of the account end date, ORSS will initiate and process the transfer request with only School approvals notated.  An additional processing fee will be taken from the available residual to reimburse the School.


CONTACTS
· Departmental Business Administrators
· Department Chair
· Office of Research Support Services
· Office of Research Services


FORMS AND ATTACHMENTS

· Residual Balance Worksheet


MISCELLANEOUS

It is very important to be sure ALL cash has been received prior to initiating the residual balance transfer process because once a clinical trial fund has been disabled, it must be re-enabled if additional payments are received. The Institution must be able to document and create an audit trail for all funds received from a sponsor. The above procedure is required again in those instances where additional cash is received on the trial.

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