MICHR Clinical Trials Office (MCTO)
Overview
The MICHR Clinical Trials Office (MCTO) supports faculty with the pre-award phase of industry-sponsored clinical trials. Staffed with a multidisciplinary team, the MCTO assists clinical research teams through the contracting, budgeting, and initial IRB application phases of study start-up. Any clinical or translational researcher at the University of Michigan who will be engaging in industry-initiated clinical trials is eligible to use the MCTO’s services at no cost to the investigator.
The goals of the MCTO are:
- Streamline work processes to reduce the time it takes to activate a study
- Alleviate administrative burden on the research team, allowing them to focus on the conduct of the research
- Partner with university stakeholders to develop template language, standard operating procedures, and best practices
- Improve industry and clinical research organizations’ perception of the University of Michigan
- Create a centralized, dedicated team to improve the communication between the investigator, the university, and the industry sponsor
Services
In partnership with the study team, the MCTO will:
- Complete the Proposal Approval Forms (PAF)
- Conduct a recruitment feasibility assessment
- Draft budgets and billing calendar
- Negotiate budget and consent language with sponsor
- Complete initial IRB application and consent/assent forms
- Facilitate approval of contract
Learn more about the MCTO and the newly enhanced eResearch Proposal Management (eRPM) system at one of three training sessions in January.
Contact
Jill Malayang
Manager, MICHR Clinical Trials Office
Email: MICHR-CTO@umich.edu
734.998.7460
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