Master Agreements are agreements that embody agreed-upon terms and conditions of a basic relationship between the University and a sponsor.
Once a Master Agreement is in place, an “addendum” or “study letter” is typically generated for each new study to be done under the Master Agreement. The Addendum sets forth the items particular to a certain study such as dollar amount, protocol name, and principal investigator. These Addenda are “attached” to the Master Agreement. This alleviates the need to negotiate the main terms of the agreement, as the majority of the terms are agreed upon and only the particulars need to be negotiated.
We currently have many Master Agreements in place and are working on several more. When dealing with the following sponsors, please inform them to use our Master Agreement:
- Abbott Vascular
- BMS (Master Confidentiality Agreement)
- Celgene Corporation
- Clinipace (Master Confidentiality Agreement)
- Clovis Oncology
- Criterium Inc. for two oncology consortiums.
- EMD Serono, Inc.
- Forum Pharmaceuticals (Former EnVivo Phaemaceuticals)
- InVivo Therapeutics Corporation
- Merrimack Pharmaceuticals
- Novo Nordisk Inc.
- St. Jude Medical, Inc.
- UCB Pharmaceuticals
- VARI-SU2C Epigenetics Dream Team Master Consortium Agreement
Confidentiality Disclosure Agreements (CDA) for Industry-Sponsored Clinical Trials
Clinical trial sponsors may require that the PI and/or study staff sign a Confidential Disclosure Agreement (CDA) or Non-Disclosure Agreement (NDA) before reviewing confidential documents, such as the Investigator Brochure, Protocol, and other non-public or proprietary information, to evaluate USC’s interest in conducting the clinical trial. CDAs and NDAs assure that the sponsor that the institution will protect the confidential information against unauthorized disclosure for a period of time. The PI may acknowledge her or his responsibilities under the CDA, but only the CTO can execute the CDA on behalf of the University.