Clinical Trials Support Office

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Button to submit an intake form The Clinical Trials Support Office (CTSO) is the management team for the seven trans-departmental Clinical Trials Support Units (CTSUs). The CTSO offers enterprise-wide standards, policies, and a common infrastructure. All clinical trials at U-M are required to be supported by a CTSU.

In our role as concierge for clinical trials, we act as a liaison between Principal Investigators and study teams to other partners across the U-M involved in clinical trials, such as the Office of Research and Sponsored Projects, the Calendar Review and Analysis Office, and IRBMED. CTSO team members, in partnership with Health Information Technology & Services (HITS), also support OnCore, our integrated and comprehensive clinical trials management system.

Easier and more timely navigation through the administrative processes of clinical trials at the U-M is our goal. If you are a faculty or study team member, CLICK HERE to start the clinical trial process, or connect with us at CTSOgroup@umich.edu.

Are you a patient looking for more information about cutting-edge trials at the U-M? Visit UMHealthResearch.org. Want to know if your study is a Clinical Trial? See below. 

HOW WE SERVE YOUR CLINICAL TRIAL NEEDS

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Feasibility Review Support

The Feasibility Review, conducted by the appropriate CTSU, looks at the whole picture of a potential clinical trial to prevent unexpected challenges in its execution and to open to accrual in a timely manner.

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Pre- and Post-Award Support

Clinical Trials Support Units keep studies on track during the pre-/post-award process. A CTSU portfolio manager follows a study along its lifecycle and assists teams on their path to study activation. 

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Study Coordinator Support

Principal Investigators can ultimately find a smoother process and save time by taking advantage of our study coordinator pool, which can provide investigators with team members who are already on staff and fully trained.

OnCore Accounts & Support
Training and Education
Work Guides

Clinical Trials Spotlight

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Metrics

Icon representing 1,338 total ctso studies
Icon representing 376 total ctso Principal Investigators
Icon representing 11137 total CTSO study subjects

IS YOUR STUDY A CLINICAL TRIAL?

A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. Correctly identifying whether your study is a clinical trial is crucial in complying with NIH policies and Michigan Medicine.

If you answer yes to the following questions, then your study qualifies as a clinical trial:

  • Does the study involve one or more human subjects?
  • Does the study involve the use of one or more interventions?
  • Does the study prospectively assign human subject(s) to an intervention(s)?
  • Does the study have a health-related biomedical or behavioral outcome(s)?

Learn more about the NIH Clinical Trial Definition at nih.gov.

Questions?

Contact us at CTSOgroup@umich.edu

MBNI Building, 205 Zina Pitcher Place, Ann Arbor, MI 48105

A list of CTSO-CTSU contacts are available in the Personnel Directory

Edited By: dagi@med.umich.edu
Last Updated: October 29, 2018 10:52 AM