Master Template Agreement
Master Template Agreement use can significantly speed the completion of contractual negotiations for a clinical trial. Master Agreements tend to require intense negotiations because its terms and conditions must be acceptable for any and all clinical trials that fall under it. A Master Agreement can take years to negotiate and finalize, but it is typically in effect for three (3) to five (5) years after signature. It is very difficult to amend the terms and conditions of a Master Agreement after it is executed by all parties.
When researchers frequently work with a specific industry-sponsor at the OUHSC, ORA often suggests to the industry-sponsor that we use previously negotiated clinical trial agreements as ‘templates’ for future studies. If an industry-sponsor will agree to the ‘template’ use, both parties still have the opportunity to renegotiate any language that may require revision due to the difference in study, change in institutional or company policies, etc. In many cases of template use, the need to renegotiate terms/conditions is quite low, resulting in a much shorter time period for finalizing the clinical trial agreement. Each industry-sponsor is unique and ultimately, it is each sponsor’s decision whether or not they will allow the use of Master Template agreements.
OUHSC has a Master Agreement with:
Amgen, Bayer, Eli Lilly, Novartis, Novo Nordisk, Wyeth,
AstraZeneca - Confidentiality Agreement Only, and
Merck – Confidentiality Agreement Only
OUHSC is negotiating a Master Agreement with:
Eisai, Merck, Pfizer and Wyeth
Sponsors who frequently allow template use include:
AstraZeneca, Boehringer Ingelhem, Bristol-Myers Squibb, GlaxoSmithKline,
Sanofi-Aventis and Schering Plough