Clinical Trials Support Units

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.

The CTSUs allow investigators to focus on their research and patients, instead of administrative tasks. CTSUs use a standard set of work guides to harmonize elements across the clinical research enterprise while allowing for local flexibility to reflect the uniqueness of various types of research. CTSUs provide mandatory pre-/post-award support and optional study coordinator support. 

When working with the Support Units, the six non-oncology units may be referred to as M-CTSU and Oncology as O-CTSU. 

M-CTSU Medical Director: Peter Higgins, M.D., Ph.D.             O-CTSU Medical Director:  Scott Schuetze, M.D., Ph.D.

Learn more about each Clinical Trials Support Unit and the unique services that they offer below. 

Acute, Critical Care, Surgery, & Transplant (ACCST)

The Acute, Critical Care, Surgery & Transplant (ACCST) 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 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.

Portfolio Manager: Johanna Foerster

Ambulatory & Chronic Disease (ACD)

The Ambulatory & Chronic Disease (ACD) CTSU is the home for all chronic, non-ICU diseases in the adult population, excluding cancer and cardiovascular disease, which constitute the majority of clinical trials in the ambulatory Internal Medicine divisions and Department of Ophthalmology & Visual Sciences. Specialties supported by the ACD CTSU include, but are not limited to, rheumatology, endocrinology, pulmonary medicine, geriatrics, nephrology, gastroenterology, and ophthalmology, which account for a large number of the ambulatory trials within Michigan Medicine.

Portfolio Manager: Elizabeth Wu

Behavior, Function, & Pain (BFP)

The Behavior, Function, and Pain (BFP) CTSU represents the group of investigators who conduct trials that involve behavioral interventions, or behavioral or biomedical trials, intended to impact the following types of outcomes: health behaviors (physical activity, self-management), psychological states (e.g. mood, anxiety), maladaptive behaviors (e.g., substance use, eating disorders), physical function (e.g., recovery from stroke, rehabilitation therapies), psychosocial function, or pain. The interventions in trials typically covered by this CTSU may involve exercise, self-management, cognitive behavioral therapy, or other non-pharmacological aspects that help manage and prevent chronic disease, illness, or disability.

Portfolio Manager: Mariam Farida

Children's

The Children's CTSU 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, mainly when there is a crossover in our investigators’ portfolios.

Portfolio Manager: Mariam Farida

Heart, Vessel, Blood (HVB)

The Heart, Vessel, Blood (HVB) CTSU enhances the performance of cardiovascular, coagulation, and nonmalignant hematologic clinical trials, including specializing in device trials and drug trials across the lifespan of acute and chronic disease. The CTSU offers specialty recruitment services, quality assurance, and junior faculty support.

Portfolio Manager: Katie Donovan

Neurosciences & Sensory (NSS)

The Neurosciences and Sensory (NSS) CTSU is a multidisciplinary, multi-departmental CTSU that aims to provide a full range of services for investigators with clinical trials related to the skin or nervous system. The CTSU is open to any trial that finds a natural fit with this CTSU‘s ability to support trials related to dermatological or nervous system conditions.

Portfolio Manager: Katie Donovan

Oncology (O-CTSU)

For over 25 years, the Oncology Clinical Trial Support Unit (O-CTSU) has served as the centralized core facility of clinical research trials conducted by investigators at the University of Michigan Rogel Cancer Center and the Michigan Medicine community.

The O-CTSU uniquely supports investigator’s reporting requirements for NCI's Cancer Center Support Grant (P30) and Clinical Trials Reporting Program. Through the O-CTSU, the Rogel Cancer Center provides free services to support U-M's NCI oversight obligations: single-site monitoring of investigator-initiated trials, auditing, informatics and database development, protocol editing, and committee support. The O-CTSU has a sizable study coordinator pool specialized in-clinic support, specimen processing, data management, regulatory, and multi-site project management; >50% of the staff are Certified Clinical Research Professionals. The Rogel Cancer Center may also subsidize these services through a Cancer Clinical Trial Support (CCTS) Award. For more information about our services and support, visit https://octsu.med.umich.edu.

Portfolio Managers: 
Karena Cattell (Blue)(Connective Tissue; Gastrointestinal; Head, Neck & Endocrine; Thoracic)
Claire Wolniewicz (Maize) (Hematologic Malignancies)
Tori Melendez (Gold)(BMT; Breast, Cutaneous; Gynecology; Neurologic)
Yan Wang (Green)(Genitourinary & Multi-Tumor)