Clinical Trials Contracting at OHSU
Clinical Trials Master Agreements At OHSU, industry sponsored clinical trial agreements are negotiated between the Sponsor and OHSU's Clinical Trials Office Contracts group (CTO-Contracts). There is no charge to investigators or sponsors for negotiating clinical trials contracts.
Negotiations of the agreement often begin when OHSU's principal investigator is initially approached to take part in a clinical trial. The agreement is usually discussed up front and often a draft agreement is sent to the PI. Forward all agreements received from industry sponsors to Clinical Trials Office Contracting to Mailcode CR 107. Alert CTO-Contracting to all agreements and proposals as soon as possible so that contract language can be reviewed and modified as necessary. If you are not sure who to direct your question to, you can email Jacqueline Brown, firstname.lastname@example.org.
During the negotiation process, PIs and study coordinators may track the status of negotiations via thePre-award look-up tool (Jellyfish)
CTO-Contracting does not develop or negotiate budgets or payment schedules. The investigator and/or study coordinator must create and finalize a budget and payment schedule and forward the final budget and payment terms to CTO-Contracting for inclusion in the agreement. Budgets must include all costs associated with completing the study, and payment schedules must ensure funds are received on a schedule that will cover expenditures. Budgets for clinical trials are developed using the Institution's research rates. Budgets should reflect 25% F&A (20% to the institution, 5% to the Departments) applied to the total direct cost of the budget and all appropriate IRB fees. To have budgets developed for you, contact the Clinical Trials Office (CTO) or contact Bridget Adams, CTO Manager at 4-5077.
PIs, as well as OHSU, are placed at legal and financial risk when a clinical trial agreement is signed by the PI without review by CTO-Contracts and without the required signature from an institutional official. Liability coverage will not be extended to the PI in cases where the required signature is not obtained.
All term extensions to the agreement, changes to the budget, changes to scope of work, or enrollment of additional subjects must be amendments to the agreement and must be reviewed by CTO-Contracting. Send any information regarding amendments to the contract analyst assigned to your department.
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