GEORGETOWN UNIVERSITY FINANCIAL AFFAIRS MANUAL Issuing Department Topic: Accounting for Cost and Sponsored Clinical Trial Activity Accounting New (X) Revised Policy # FA 119-06 Supersedes Policy 100.01 POLICY: Accounting for Clinical Trial Activity 100.02 STATEMENT: Revenue earned from industry sponsored clinical trials will be based upon the trial activity (i.e., set fees and patient milestones). 100.03 APPLICABILITY: The policy applies to all departments that have industry sponsored (non-federal) clinical trials agreements (i.e., cost centers designated as Cashflow 2). 100.04 PURPOSE: The purpose of the policy is ensure that revenue from industry sponsored clinical trials is properly recorded and to detail responsibilities associated with accounting for such trials at the University. 100.05 ADMINISTRATION: Budget Preparation Trial Data Financial Data Posting of Revenue Budget Monitoring Clinical Trials Office (CTO) will coordinate with Principle Investigators, the Medical Center Office of Sponsored Research (MCOSP), the office of the Medical Center CFO, and department administrators to establish a budget for the clinical trials. Budgets will be based upon a reasonable expectation of patient activity and the associated fixed and variable costs. Anticipated surpluses can be budgeted to account code 78442. Trial Coordinators will provide department administration with patient data. Department administrators will convert patient data to financial data based upon the clinical trial agreement. Medical Center Finance Office will prepare a journal voucher based upon the data received from the department to post revenue and the associated receivable. Revenue will be posted to account code 51214 and a receivable to account code 02826. The CSR for Industry Sponsored Trials (Cashflow 2) will reflect both budgeted variances, revenue and expense differences, and cash balance information to assist Effective Date 07/01/05 Collection of Receivables Closeout of Award 100.6 DEFINITIONS Clincial Trials: Revenue: Cash Collected: Trial Data: Financial Data: departments and Medical Center Finance with monitoring the financial aspects of the clinical trials. All checks will be sent to the Sponsored Accounting Office (SAO). Cash will be posted to the receivable account with the assistance of the CTO. SAO will monitor collections and will coordinate efforts with the CTO to receive cash from delinquent sponsors. At the expiration of the trials, SAO will confirm with the department that the trial is ended. The department will confirm that all costs have been appropriately charged. Revenue and expenses will be balanced using account code 78442 (surplus transfer account). Surplus funds will be transferred to the Medical Center Clinical Trial holding account pending release to the department. All transfers will be made to GD accounts and subject to all budgetary constraints associated with GD’s. The trials under this policy are industry sponsored (i.e, nonfederal) trials that sponsors pay the University based upon fix fees for trial milestones. They are to be designated as Cashflow 2 in the grant management system by MCOSP. Revenue is recognized based upon terms of the clinical agreement and not upon cash collected or expenses incurred. Cash receipts collected from sponsored and posted against receivable account. Patient milestone information (i.e., Four patients have been given treatment A). Patient milestone data converted into the financial terms of the agreement (i.e., agreement pays $1,000 per patient). 100.07 RESPONSIBILITIES: Clinical Trial Office Trial Coordinator Clinical Department Campus Finance Office Sponsored Accounting Budgeting, collection assistance. Collection of patient data. Conversion of patient data to financial data, budget monitoring. Preparation and posting of revenue voucher, receivable balance monitoring, and budget monitoring. Receipt and deposit of cash receipts, monitoring of collections, closeout of cost center. 100.08 ENFORCEMENT: SAO and Internal Audit will work with senior management to ensure that departments are in compliance with this policy. 100.09 RESOURCES: Office of Cost and Sponsored Accounting 100.10 APPROVAL: The Assistant Vice President, Administrative Services approves the policy. 100.11 REVIEW CYCLE: The policy is reviewed annually by the Director of Cost and Sponsored Accounting with input from the directors of OSP and MCOSP and campus CFOs.