OHSU

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.

OHSU Investigators

Information about clinical trials contracting at OHSU

Sponsors

Send clinical trials agreements for negotiation directly to the Clinical Trials Office - Contracting:

Oregon Health & Science University
Clinical Trials Office - Contracting
3303 SW Bond Ave., Mail Code: CH15T
Portland, OR 97239
(503) 494-6661

 

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
 
 

 

  • 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 192.549
 

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.

Institution Address:
3181 S.W. Sam Jackson Park Road

Portland, Oregon 97239

Mailing Address for Payments (Payee): Oregon Health & Science University
Sponsored Projects Administration
Mail Code: L106SPA
0690 SW Bancroft
Portland, OR 97239
OHSU Taxpayer ID Number: 93-1176109
Financial Matters: Nancy Duncan

Director, Sponsored Projects Administration
Tel: 503-494-1193
FAX: 503-494-1191

Contract Matters:
Darlene Kitterman, MBA
Director, Investigator Support & Integration Services
Oregon Clinical & Translational Research Institute
Tel: 503-494-6263

 

Jacqueline Brown, J.D.
Contracting Manager, OHSU Clinical Trials Office
Tel: 503-494-6661

IRB Matters:

Kathryn Schuff, MD, MCR
IRB Chair,  Mail Code: L106
0690 SW Bancroft Street
Portland, Oregon 97239
Tel: 503-494-1685
FAX: 503-494-0157