Industry Sponsored Clinical Trial Contracting

At OHSU, industry sponsored clinical trial agreements are negotiated between the sponsor and OHSU's Clinical Trials Office Contracts group (CTO-Contracts). 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 also will sign the contract, although investigators are not a party to the contract.

OHSU INVESTIGATORS: click here for a link to information about clinical trials contracts at OHSU.

SPONSORS: You may send clinical trials contracts for negotiation to the PI/study team or directly to the Clinical Trials Office - Contracts group:

Oregon Health & Science University
Clinical Trials Office - Contracts
3303 SW Bond Avenue, Mail Code CH15T
Portland, OR 97239
CRP@ohsu.edu
(503) 494-7634

Contact the Clinical Trials Office - Contracts if you would like to request a copy of our Clinical Trial Agreement template for use in lieu of your contract template.

Any 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 - Contracts at the address given above.

Explanation of Selected Provisions Required By OHSU For Clinical Trial Agreements:

1. PREAMBLE: The Institution and Sponsor are parties to the agreement. Principal Investigators may sign the agreement as "read and acknowledged" but are not party to the agreement and may not sign on behalf of the Institution.
    
2. 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.
    
3. 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. 
    
4. 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.
    
5. 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 explanation of this policy. In addition, refusing coverage for subjects who "do not follow instructions" is not permitted: see Subject Injury Policy - Following Instructions.
    
6. INSURANCE: If OHSU is required to provide insurance during the trial, the type and limits of insurance are set out by Oregon statute. Under enabling law ORS 353, the Institution is a public corporation and political subdivision of the State of Oregon. Limitations are set forth pursuant to the Oregon Tort Claims Act (ORS 30.260 through 30.300).
    
7. 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.
    
8. COMPLIANCE WITH LAW: Sponsor must agree to comply with all applicable laws and regulations.
    
9. COMPENSATION: Payments are payable to: Oregon Health & Science University. Payments should be mailed to:
    
        Oregon Health & Science University
        Sponsored Projects Administration
        2525 S.W. First Avenue, Suite 220
        Portland, OR 97201
    
   All payments to OHSU should indicate the name of the PI and Protocol Number.
    
10. GENETIC PRIVACY ACT. For studies that require obtaining genetic information from study patients, language regarding Oregon's statute on genetic privacy is required.
     
11. DEBARMENT: Per OMB Circular A110.13, OHSU, as a federal award recipient, may not contract with entities that have been debarred or otherwise excluded or sanctioned by any federal agency. See Debarment Explanation for more information.
     
12. USE OF INSTITUTION'S NAME: Sponsor may not use name of Institution or its employees for advertising or promotion without written consent of Institution.

OHSU Information Sheet
 
Oregon Health & Science University is a Public Corporation organized under the laws of the State of Oregon. A W-9 will be provided with the executable version of the contract.

Last modified on 01/16/2008 by rdaweb@ohsu.edu