For Fixed Price, Industry-Sponsored, -Designed, or -Funded as well as Investigator-Initiated Clinical Trial Award(s)
Effective July 1, 2020
This procedure outlines requirements that are intended to facilitate the timely closeout and allocation of residual funds for fixed-price industry-sponsored, designed, or funded and investigator-initiated clinical trials.
For residual funds for clinical trials funded directly or indirectly through awards or subawards/subcontracts with any federal, state, or local government agency or entity; any international government agency or entity; or any foundation or non-profit organization, please refer to the GW residual transfer policy referred here.
At the end of the trial, there may be a residual balance remaining on the award(s). If so, balance transfer occurs after confirming all labor and other non-labor expenditures were accurately allocated to the award(s) per their approved budgets and as determined through the closeout and PI certification process with Grants and Contracts Accounting Services (GCAS).
In addition, all billable revenue must be received and confirmed with POD/School Research Administration, Dept/admin, and/or the Office of Clinical Research (OCR)/SMHS Finance team. The timeline for closeout and PI certification process is governed by the Award Management and Closeout Policy.
- For awards that transferred to GW oversight effective July 1, 2020 and new awards with a start date of July 1, 2020 and thereafter, residual balances will be transferred as follows: 40% to the PI, 10% to the PI home Department/Division or affiliated Center based on discussions with the Chair and 50% to SMHS leadership for investment in clinical/translational research such as Pilot Grants and Office of Clinical Research infrastructure support.
By completing the closeout and PI certification process, it is recognized that the Department/Division is required to pay any additional costs applicable to the clinical trial that may arise after the transfer (such as costs associated with an FDA audit or document storage costs) out of Department /Division funds. The Department/Division also recognizes that the residual funds, even if assigned to a particular investigator, will remain with the institution, GW, or the MFA, and therefore may not be reassigned to another institution should that investigator resign. The use of the residual funds will be limited to the Permitted Purposes defined below supporting the mission of the academic medical enterprise and may not be used to directly and personally benefit any individual for private expenses (i.e. those not related to Medical Faculty Associates, Inc. or GWU business or missions).
Use of Residual Funds
Clinical Trials Residual balances must be used to support and enhance the research-related and scholarly activity of the Department/Division/PI. Examples include attendance at scientific meetings/conferences, research-related association or society dues and registration fees, publication costs, related research, and/or unfunded research as applicable, including the salary & benefits of the PI or other research staff/personnel.