Clinical Trials Contracting at OHSU

At OHSU, industry sponsored or supported clinical trial related agreements, including confidentiality agreements (CDAs or NDAs) Clinical Trials Master Agreements investigator initiated clinical trial agreements (providing industry funding and/or free drug/device/equipment), related sub-agreements and amendments are negotiated and signed by OHSU's Clinical Trials Office-Contracting unit (CTO-Contracting). There is no charge to investigators or industry sponsors/supporters for negotiating these agreements. If you have any questions regarding CTO-Contracting, please contact CTO-Contracting Manager, Jacqueline Brown, at 4-6661 or .

As soon as possible, please alert CTO-Contracting of all potential industry sponsored/supported studies and forward all related agreements and amendments received from industry sponsored/supporters to CTO-Contracting's Contracts Assistant, Emily Purdin, Mail Code: SN4N, or so that the contract language can be reviewed and modified as necessary by the Contract Analyst assigned to your department as necessary.  If you are not sure which OHSU contracting office should handle your agreement, please contact Jacqueline Brown, or OHSU's Contract Triage Analyst at .

During the negotiation process, PIs study team may track the status of negotiations via eCRIS or the Pre-award look-up tool (Jellyfish), depending on the age of the study.

CTO-Contracting does not develop or negotiate budgets or payment schedules. The investigator and/or study team must create and finalize a budget and payment schedule for each study. Once completed, please forward the final budget and payment terms to CTO-Contracting Contract Analyst assigned to your agreement or amendment in eCRIS or Jellyfish 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 all appropriate IRB fees and 28% F&A (23% to the institution, 5% to the applicable department(s)) applied to the total direct cost of the budget. (see Industry Funded Clinical Trial Budget and Payment Terms information sheet).

If you are interested in having a study budget developed for you, please contact the Clinical Trials Office (CTO) or Bridget Adams, CTO Manager, or 4-5077.

PIs, as well as OHSU, are placed at legal and financial risk when an industry sponsored/supported clinical trial related agreement is signed by the PI without review by CTO-Contracting 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