Welcome. CTO is here to help OHSU researchers with industry supported clinical trial contract negotiation services. Contact us.
Welcome to Clinical Trials Contracting
At OHSU, industry sponsored or supported clinical trial related agreements, including confidentiality agreements (CDAs/NDAs), Clinical Trial 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 Clinical Trials Contracting (CTO). There is no charge to investigators or industry sponsors/supporters for negotiating these agreements.
As soon as possible, please alert CTO of all potential industry sponsored/supported studies and forward all related agreements and amendments received from industry sponsors/supporters to the assigned Contract Officer for review.
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.
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.