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
Clinical Trials Spotlight
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.