Clinical Trials Support Units (CTSUs)

What are Clinical Trials Support Units (CTSUs)?

  • Clinical Trials Support Units, formerly called “nodes,” are business units that partner with investigators and their teams to ensure the timely and efficient activation and execution of clinical trials at UMHS
  • A faculty Medical Director(s) experienced in conducting clinical trials leads each unit with support from a senior administrator
  • PIs with existing clinical trials that will continue beyond July 2018 are encouraged to contact and join one of the seven Support Units.

How will the CTSUs help me?

  • Support Units allow investigators to focus on the science instead of the administrative tasks.
  • The objective of the Research Board of Directors (RBOD) is to ensure that a common, high value infrastructure is available to all faculty irrespective of their home department. The Support Unit is envisioned to be a “one-stop shop.” Having CTSU staff dedicated to and expert in clinical trial activity provides highly competent support to increase the efficiency of trial activation as well as offer PIs the option of utilizing study coordinators from the Support Unit resource of trained coordinators. The Support Unit study coordinator resource provides continuity during study team turnover, retains highly competent study personnel during periods of reduced PI funding, and cushions faculty from carrying full personnel expenses when they only need fractional support.
  • The new model provides a more structured and formalized path for developing investigators early in their career or new to clinical trial research.  Similarly, study coordinators will have a defined path for professional and career development.
  • Support Units will use a standard operations manual to harmonize elements across the clinical trial enterprise, while allowing for local flexibility to reflect the uniqueness of various types of trials. 
  • With stronger institutional support for clinical trials, UMMS will be able to retain and recruit clinical scientists and improve our national visibility.  We aim for faculty and study personnel to experience easier navigation through the administrative processes, stronger support, and increased satisfaction.

What services are provided?

  • Support Units provide all of the same core services, including:
    • Pre- and post-award Support
      • Services include but not limited to feasibility review, billing calendar creation, budget preparation and negotiation, contracting support, site initiation support, account reconciliation, milestone tracking, and invoicing. 
      • Regulatory support, including: to assistance with preparation of the IRB application, amendments, and consent forms.
    • Study coordinator staffing, training and coordination
      • Services span all aspects of clinical trial-study coordination. 
      • A pool of trained study coordinators is available to assist with activities like identifying, screening, consenting, and enrolling subjects, collecting and managing data, collecting, packing, and shipping specimens, data entry using Case Report Forms, reporting Adverse Events and Serious Adverse Events, and liaising with sponsor, departments, and patients.
  • Some support units also provide unique services, catering to their respective unit. More information about these services is located on their CTSU webpage.
  • Support Units will operate using a standard operations manual to harmonize elements across the clinical trial enterprise, while allowing for local flexibility to reflect the uniqueness of various types of trials. 

How does MICHR Support the CTSUs?