Industry Sponsored Clinical Trial Contracting
At OHSU, industry sponsored clinical trial agreements are negotiated between the sponsor and OHSU's Clinical Trials Office Contracting Unit (CTO-Contracting). Although agreements cannot be signed until full IRB approval is obtained for the study, our goal is to have the contract negotiations completed prior to receipt of IRB approval. When final, the agreement is signed by the Sponsor and OHSU. The investigator may also sign the contract as "read and acknowledged" although investigators are not a legal party to the contract.
Send clinical trials agreements for negotiation directly to the Clinical Trials Office - Contracting:Oregon Health & Science University
Clinical Trials Office - Contracting
3181 SW Sam Jackson Park Road, Mail Code: SN4N
Portland, OR 97239
OHSU's template may be used in lieu of your contract template. Please call 503-494-6661 to request.
Any term extensions to the agreement, changes to the budget, changes to scope of work, or enrollment of additional subjects are considered amendments to the agreement and must be sent to the Clinical Trials Office - Contracting at the address given above.
Explanation of Selected Provisions Required By OHSU For Clinical Trial Agreements:
- CONFIDENTIAL INFORMATION: In "Confidential Information" clauses contained in clinical trial agreements, the Institution and Principal Investigator agree to hold information confidential "to the extent permitted by the Oregon Public Records Law". The Oregon Public Records Law does not allow OHSU to hold the existence of the agreement confidential.
- PUBLICATION & USE OF STUDY DATA: The Institution and Principal Investigator MUST be allowed to publish data from a clinical study at some reasonable time. A 30 day review by a sponsor before publication for identification of sponsor-owned or confidential material and/or patentable materials is acceptable. In multi-center studies, publication 12 months after study termination at last study site is acceptable. See Publications Position for more information. The Institution must retain the right to use data collected during the study and that are retained by Institution. See Data Use Position for more information.
- INDEMNIFICATION: Sponsor must indemnify the Institution and Principal Investigator against all claims. Indemnification cannot be limited to the study drug or study device. See Indemnification Position for additional information.
- SUBJECT INJURY: Provision must be made for the payment of any and all medical treatment reasonably necessary for study subjects injured as a result of their participation in a study. For more information on this clause, see OHSU's policy on Sponsor Liability in Clinical Trials and the accompanying CMS Quick Reference Guide. In addition, refusing coverage for subjects who "do not follow instructions" is not permitted: see Subject Injury Policy - Following Instructions
- GOVERNING LAW: Institution as a state public corporation can only be bound by Oregon law. In the alternative, the agreement can be silent as to governing law.
- GENETIC PRIVACY ACT: For studies that require obtaining genetic information from study patients, language regarding Oregon's statute on genetic privacy is required. §§ O.R.S. 192.531 to 192.
OHSU Information Sheet
Oregon Health & Science University is a statutory public corporation organized under the laws of the State of Oregon. A W-9 will be provided with the executable version of the contract, or is available to OHSU employees to provide to sponsors where appropriate here.
||3181 S.W. Sam Jackson Park Road
Portland, Oregon 97239
|Mailing Address for Payments (Payee):||Oregon Health & Science University
Office of Proposal and Award Management
Mail Code: L106OPAM
0690 SW Bancroft
Portland, OR 97239
|OHSU Taxpayer ID Number:||93-1176109|
|Financial Matters:||Pat Cloteaux
Manager, Post Award
||Darlene Kitterman, MBA
Director, Investigator Support & Integration Services
Oregon Clinical & Translational Research Institute
Jacqueline Brown, JD
Kathryn Schuff, MD, MCR