Children's

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The Children's Clinical Trials Support Unit (Children’s) specializes in clinical trials involving the pediatric population. The unique needs of children and their families are the focus of this CTSU. Building on the existing success of investigator-initiated and NIH trials, the Children’s CTSU aims to continue growing the number of pediatric industry-sponsored trials, all while remaining focused on providing the safest clinical research environment for the children enrolled as participants. This CTSU also supports trials in the adult population, particularly when there is crossover in our investigators’ portfolios.  

In addition to the standardized pre- and post-award support provided by each CTSU, the Children’s CTSU offers a robust team of study coordinators ready to support your trial. This highly trained and skilled team provides each trial with the study team support necessary for successful completion and covers a pager 24/7/365 to address any issues that arise during off hours and has the capacity to support off hours as needed. 

Children's staff is experienced in the operations, regulatory and clinical conduct of FDA-regulated, investigator-initiated, and grant-funded complex inpatient trials.

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.

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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. LEARN MORE.

 

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



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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. LEARN MORE.
 

METRICS

330 Childrens Studies          81 Childrens Principal Investigators          3,334 Childrens Study Subjects

FACULTY AND STAFF

Medical Directors

Caren Goldberg, M.D.

Portfolio Managers

Ranae Hoeft, M.S.hoeftr@umich.edu, 734-647-8922
Heather Goldengoldenh@med.umich.edu, 734-998-7636
 

 

Questions?

Contact us at CTSU.Childrens@umich.edu

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

A list of Children's CTSU contacts are available in the Personnel Directory.