Clinical Trials Support Office

The Clinical Trials Support Office (CTSO) is the central hub for the trans-departmental Clinical Trials Support Units (CTSUs), providing enterprise-wide leadership, standards, policies, and a common infrastructure. 

Get Started! Submit a CTSU Intake Form
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Spotlight On
Michigan Medicine Site Profile

View the Michigan Medicine Clinical Research Site Profile for an overview of the resources we offer to support clinical research.

How We Serve Your Research Needs

Our goal is easier and more timely navigation through the clinical research administrative process at Michigan Medicine.

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Clinical Trials Support Units (CTSUs)

Clinical Trials Support Units (CTSUs) are business units that partner with investigators and their teams to ensure the timely and efficient activation and execution of clinical trials at Michigan Medicine.

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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.

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Michigan Clinical Research Unit (MCRU)

The Michigan Clinical Research Unit (MCRU) provides clinical staff, resources, and infrastructure that are necessary to conduct adult and pediatric human clinical research protocols at the University of Michigan.

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Training, Education, and Resources

The Clinical Trials Support Office provides a structured and formalized path for developing faculty and study teams early in their career or new to clinical trial research.

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The Clinical Trials Support Office and CTSU team members are here to help faculty and study teams easily and efficiently navigate the clinical research process, with greater support and increased satisfaction.

With this strong institutional backing of clinical research, Michigan Medicine is able to retain and recruit top-tier clinical scientists, improve our national visibility, and demonstrate the value of clinical trials to patients, families, and society.

Anna Lok, MD
Assistant Dean for Clinical Research
Anna Lok
CTSO FY24 At A Glance
1,545
Studies
500
Principal Investigators
27,880
Study Subjects
Clinical Trials at Michigan Medicine
Contact Us
Clinical Trials Support Office
Medical School Office of Research
M-CTSU: North Campus Research Complex, Building 520
O-CTSU: North Campus Research Complex, Building 300
2800 Plymouth Road
Ann Arbor, MI 48109
About Us

The Clinical Trials Support Office is a unit of the Medical School Office of Research, where our mission is to foster an environment of innovation and efficiency that serves the Michigan Medicine research community and supports biomedical science from insight to impact.

Upcoming Research Events All Office of Research Events
Amendments and Continuing Reviews
This course is a follow-up to Initial Project Applications and will examine the process for submitting amendments and scheduled continuing reviews to IRBMED using eResearch once a project’s initial application has been approved.
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Data and Safety Monitoring Boards and Data Safety Monitoring Plans
This course will review when studies are required to have a DSMP or DSMB and how to develop an appropriate DSMP. A DSMB is an independent group that advises the study team regarding subject safety, study conduct, and efficacy. The DSMB will also make recommendations concerning the continuation, modification, or termination of the trial. A DSMP outlines how subject safety and data integrity will be maintained to ensure the validity of collected data.
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Storage and Retention of Data
This course will review the fundamentals of maintaining confidentiality of subject data, including data encryption and protection, using secure environments and external websites, and distinguishing among anonymized, coded, and de- identified datasets.
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Introduction to sIRBs
This course will identify the Single IRB model for Multi-Site research, show the regulatory requirements of sIRB review and the exceptions to sIRB requirements, and explain sIRB requests of IRBMED as sIRB (accepting oversight), External IRB as sIRB (ceding oversight), and UofM as the Coordinating Center.
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FDA Research Involving Drugs and Devices
This course will review what research is subject to FDA oversight, highlight the differences between OHRP and FDA regulations, learn the responsibilities of sponsors, investigators, and the IRB when conducting and reviewing research involving drugs and devices, and examine the requirements for conducting research with a drug or biologic/medical device.
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Not Regulated, Secondary Use, and Umbrella Applications
This course will review the Not Regulated, Secondary Use, and Umbrella application types in eResearch and when these application types are applicable.
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OHRP’s Subparts B, C, and D - Special Populations
This course will examine the additional regulatory requirements for conducting research involving pregnant women, fetuses, neonates, children, and prisoners, including the requirements for these populations in a research project and obtaining informed consent.
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Federal and Institutional Requirements for Human Subject Research
This course will introduce the basics of conducting human subject research in compliance with federal regulations and institutional practices.
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Elements of Informed Consent
This course offers an overview of informed consent in human subject research. The course will examine IRBMED’s standard consent template and focus on how it reflects federal requirements.
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Featured Research News All Office of Research News " "
Office of Research
University of Michigan AVITI24 Grant Program
The AVITI24 Grant Program is an opportunity for you to push your research further and faster.
Sahiti Marella in the lab
Office of Research
2024 Research Annual Report Released
Medical School releases 2024 Research Annual Report
Cassie Wong
Office of Research
Cassie Wong Appointed Senior Director for Research in the Medical School Office of Research
Cassie Wong named the Senior Director for Research in the Medical School Office of Research, effective December 1, 2024.