Clinical Trial Agreements
The Office of Research and Sponsored Projects (ORSP) at the University of Michigan is responsible for negotiation of clinical trial agreements. Learn about clinical trial agreements and support.
A clinical trial is a research study in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. The Office of Research and Sponsored Projects (ORSP) at the University of Michigan is responsible for negotiation of clinical trial agreements. These negotiations are handled by the Clinical Trials Team (under the Contracts Team).
The Clinical Trials Team partners with industry sponsors, federal agencies and foundations to negotiate and execute agreements that support clinical research across the institution. The team ensures that each contract aligns with university policies, regulatory requirements and applicable laws. This helps facilitate the timely launch of studies that advance medical discovery and bring innovative treatments to patients.
Clinical Trials Support Units
U-M Clinical Trials Support Units (CTSUs) partner with investigators, their teams and their departments to ensure the timely and efficient activation and execution of clinical trials at Michigan Medicine. CTSUs provide the administrative support to allow investigators to focus on the science.
At Michigan Medicine, all NIH-defined clinical trials and clinical research that has a billing calendar are required to be supported by a CTSU. CTSUs provide mandatory pre- and post-award support and optional study coordinator support.
The first step is to fill out the CTSU Intake Form. The CTSU will then process the clinical trial agreement and shepherd the trial through the pre-award processes. The CTSU works closely with an ORSP officer who specialize in clinical trials.
The Accelerated Clinical Trials Agreement
The Accelerated Clinical Trials Agreement (ACTA) is a standardized clinical trial agreement designed to streamline contract negotiations for industry-sponsored, multi-center clinical trials, reducing study start-up times and accelerating patient access to clinical trials. U-M was a key partner in the development of the ACTA and continues to contribute to its ongoing refinement and implementation to support efficient, collaborative and compliant research partnerships. U-M supports and encourages the use of the ACTA.
Forms are available for viewing and download on the Accelerated Research Agreements website.
Clinical Trial Masters Agreements
Master Clinical Trial Agreements (MCTAs) provide agreed-upon terms and conditions between U-M and a sponsor. U-M has MCTAs with more than 50 sponsors. When interacting with sponsors under an MCTA, inform them that an agreement is in place.
ORSP is continually working on revisions, renewals and/or new agreements. For questions about sponsors and MCTAs, contact the Clinical Trials Team.
- Abbott
- AbbVie, Inc.
- Adaptimmune, LLC
- Allergan, Inc.
- Amgen, Inc.
- Alnylam Pharmaceuticals
- Ardea Biosciences, Inc
- Astellas Pharma US, Inc.
- AstraZeneca/Medimmune
- Bayer Healthcare Pharmaceuticals
- Biogen
- Biogen Idec, Inc.
- Biotronik, Inc.
- Boehringer Ingelheim, Ltd.
- Boston Biomedical, Inc.
- Bristol-Myers Squibb
- Celgene
- Cochlear Americas
- Cook Incorporated
- Dentigenix, Inc.
- Discovery Laboratories, Inc.
- Dompé S.p.A.
- Eli Lilly and Company
- EMD Serono, Inc.
- Genzyme Corporation
- GlaxoSmithKline
- Hoffman-La Roche, Inc.
- Janssen Research and Development LLC
- ImClone Systems, Inc.
- Immune Therapeutics
- Incyte Pharmaceuticals
- InterMune, Inc.
- MacroGenics, Inc.
- MDxHealth, Inc.
- MedImmune LLC (a fully owned Affiliate of AstraZeneca Pharmaceuticals, LLC)
- Medtronic
- MeiraGTx
- Merck Sharp & Dohme Corp.
- Millendo Therapeutics
- Millennium Pharmaceuticals, Inc.
- Novartis Pharmaceuticals Corp
- Novo Nordisk, Inc.
- OncoMed Pharmaceuticals, Inc.
- Pfizer, Inc.
- Pharmacyclics, Inc.
- Pharmatech Oncology, Inc.
- Purdue Pharma L.P.
- Regeneron
- Sanofi-Aventis U.S., Inc.
- Seattle Genetics, Inc.
- Siemens Healthcare Diagnostics, Inc.
- Sunesis Pharmaceuticals, Inc.
- Target PharmaSolutions, Inc.
- UCB Biosciences, Inc.