Summary: UVA SOM Recommended Steps for Successful Institutional Recovery from Industry
Sponsored Clinical Trials
1) Contract/Budget Negotiations
a. Whether you are new to the clinical trials process or a seasoned veteran, please
check with the budget coordinator in the SOM Clinical Trials Office for guidance
and updates on current best practices relative to appropriate budget
development prior to entering into any financial agreement with industry.
b. Take the time necessary to make sure that all costs associated with the trial
(Medical Center, Physician, Department, etc.) are fully identified and included in
the proposed budget. Underestimating costs leads to financial stress within your
unit and inappropriate subsidization of industry. Overestimating costs can not
only damage your reputation with sponsors, but in some cases could expose the
institution to significant liability.
c. The first step towards a successful revenue recovery process is the negotiation
of reasonable and consistent payment terms as part of the contract with industry
d. Set enrollment targets as part of the budget negotiations but also negotiate
payment terms that will cover your incurred costs whether or not you meet the
e. Avoid holdback clauses in any agreements if possible. They make payment
reconciliation extremely difficult.