Industry-Initiated Study Start-Up

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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. 

 

Industry-Initiated Study Start-Up

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