Clinical Trials Support Office

Clinical Researcher with Patient


HUMAN RESEARCH REACTIVATION INFORMATION

Research leadership from across the University of Michigan campuses are working together to safely re-engage research in accordance with state regulations. Visit the CTSO's Human Research Reactivation website to learn the latest human subjects research reactivation information impacting studies supported by the CTSO such as:

  • Human Research Activation Tier Framework
  • Human Research Activation Checklist & Key Dates
  • Human Research Training Module & Return-to-Work Attestation
  • Safe Research Plans
  • Medical School Office of Research Requirements - Including IRBMED, IDS, and OnCore Considerations
  • Sponsor Visit Guidelines
  • Contact Tracing Information
  • CRAO Guidance for COVID-19 Testing
  • Michigan Clinical Research Unit (MCRU) Information

For questions regarding Human Research Reactivation for CTSO-supported studies, email MM-Clinical-Research@umich.edu.

Looking for information on starting a COVID-19 Clinical Research project? Click here. 

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CLINICAL TRIALS SUPPORT OFFICE

The Clinical Trials Support Office (CTSO) is the central hub for the seven trans-departmental Clinical Trials Support Units (CTSUs), providing enterprise-wide leadership, standards, policies, and a common infrastructure. All clinical research at Michigan Medicine that has a billing calendar is required to be supported by a CTSU, but some exceptions may apply. 

In our role as concierge for clinical research, we act as a liaison between Principal Investigators and study teams to other partners across the U-M involved in clinical research, 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 research at Michigan Medicine is our goal. If you are a faculty or study team member, CLICK HERE to start the clinical research process, or connect with us at CTSOgroup@umich.edu.

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.

Button to submit an intake form Button for Study Coordinator Support information
Button to learn more about the michigan clinical research unitButton for ACCST CTSU
Button for BFP CTSU
Button for Children's CTSUButton to visit HVB CTSU page
Button to visit NSS CTSU pageButton for Oncology CTSU

Featured Clinical Trials Spotlights

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Microscopic photo of KRAS G12c mutation
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VIEW ALL FEATURED SPOTLIGHTS

Metrics

2382 All CTSO Studies
671 Total CTSO Principal Investigators
71,852 ALL CTSO subjects

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: July 24, 2020