Acute, Critical Care, Surgery & Transplant

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The Acute, Critical Care, Surgery & Transplant (ACCST) Clinical Trials Support Unit (CTSU) provides specialized services in recruitment and enrollment for clinical trials conducted through EMS, Emergency Department, Transplant Center, Intensive Care, or Acute Inpatient hospital settings. ACCST staff is experienced in the operations, regulatory and clinical conduct of FDA-regulated, Investigator-Initiated, and grant-funded complex inpatient trials.

This CTSU is skilled at providing the research support for studies involving unscheduled, time-sensitive enrollment and rapid transitions of care across multiple physical locations and provider teams. The ACCST CTSU has a unique challenge of competitive screening and enrollment of a fixed population of patients that typically enter our facility through the Emergency Department or Transplant Service.

The ACCST CTSU uniquely offers screening approaches that are tailored to meet the trials and patients to be enrolled. These screening mechanisms are in ‘real time’ to meet the enrollment needs of acute trials. ACCST offers study teams that are staffed seven days a week with extended evening coverage and weekends plus day-shift coverage on Saturday and Sunday. ACCST staff is experienced in conducting exemption from informed consent trials and obtaining remote consent of a legally authorized representative. Consent scripting workshops that involve role-playing to learn proper approaches and phrasing are available for study teams that may encounter challenges in acquiring informed consent due to time-sensitive enrollment or difficult conversations with patients and/or families.

ACCST is piloting a project that will identify how to facilitate increased awareness and engage key stakeholders to avoid competing for enrollment between clinical trials and observational studies that occur in the Emergency Department and Intensive Care Units. 

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

icon representing 86 accst studies          icon representing 46 accst investigators          icon representing 666 accst subjects

FACULTY AND STAFF

Medical Directors

Robert Hyzy, M.D.
Pauline Park, M.D.
Phillip Scott, M.D.

Lead Administrator

Barbara Munseybmunsey@med.umich.edu, 734-615-4147

 

Questions?

Contact us at CTSU.AcuteCriticalCareSurgeryTransplant@umich.edu

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

A list of ACCST CTSU contacts are available in the Personnel Directory.