What is this service?
The MICHR Clinical Trials Office (MCTO) supports U-M investigators and their study teams with the pre-award phase of clinical trials. Staffed with an experienced multidisciplinary team, the MCTO assists clinical research teams through the legal, financial, and regulatory phases of study start-up. Specifically, in close partnership with the study team, the MCTO will:
- Complete and track the confidentiality agreement (CDA)
- Complete the clinical trial routing form (CTRF)/proposal approval form (PAF)
- Create, negotiate, and finalize clinical trial budgets and billing calendars
- Complete initial IRB application and coordinate the review process for projects using either a central or the local IRB. This includes creating and negotiating language used in trial consent/assent forms and creating the required study billing calendar
- Facilitate approval of contract
Who can use this service?
These services are available to all study teams.
When should I contact MICHR about this service?
We encourage study teams to contact us early in the start-up of the project.
How much does this service cost?
All services are provided at a flat rate per project, with the exception of billing calendars (hourly charge). These costs can be negotiated as part of the start-up costs covered by the sponsor.