The NIH Clinical and Translational Science Award (CTSA) to ICTR supports the creation and coordination of a large clinical research infrastructure at UW. In many instances, our NIH funding is blended with local resources to sustain the research infrastructure, while continuing to introduce innovative service lines and new programs to meet changing needs as well as ongoing NIH mandates. While many of our research services are no-cost to an investigator, user fees do exist for some. An initial consult with an ICTR program is always free.
Services that ICTR either partially or completely underwrites include the Clinical Research Unit in UW Hospital and Clinics (UWHC), the Office of Clinical Trials (OCT), the ICTR Data Monitoring Committee (DMC), the Marshfield clinical research center, the Wisconsin Network for Health Research (WiNHR), the Wisconsin Education and Research Network (WREN), and the UWHC Pharmaceutical Research Center (PRC).
The resources collected in this toolkit were created to assist investigators and research teams at various timepoints throughout a clinical research study.
ICTR Regulatory & Compliance Services
Clinical Research Unit (CRU)
The Clinical Research Unit (CRU) is a 24/7 unit located on D6/6 in UW Hospital (600 Highland Ave. Madison, WI 53792). The CRU serves both investigator-initiated and industry studies, in subject populations ages 13 and above. The CRU has an RN research staff, a nurse practitioner, a bionutritionist, and a sample processing lab. All nursing staff are Advanced Cardiac Life Support and chemotherapy certified. As a hospital unit, the CRU must follow hospital policies and Joint Commission requirements.
The CRU has 15 inpatient-outpatient rooms, two outpatient rooms, and a four-bay outpatient treatment area. For federal and other investigator-initiated studies, nursing services and rooms are provided at no cost to ICTR members. The CRU also welcomes industry studies, for which the sponsor pays hospital-based research charges.
Learn more about the CRU here.
Data Monitoring Committee (DMC)
The ICTR Data Monitoring Committee (DMC) meets the requirements for an independent Data and Safety Monitoring Committee or a Data and Safety Monitoring Board. The DMC is available for UW-Madison investigators when a funding agency, the PI, or IRB requires such a committee or board.
Learn more about the DMC here.
Learn more about the OCT here.
Institutional Review Boards (IRBs)
IRB approval or exemption is required before you can begin human subjects research. There are four IRBs at UW-Madison, the IRB of ICTR partner Marshfield Clinic, and a Wisconsin IRB consortium. Check below for the appropriate IRB for your study.
- Health Sciences IRB reviews research protocols involving medical interventions or procedures where medical expertise is required for evaluation. The HS-IRB contracts with the Western IRB to review most industry-sponsored research: see http://www.grad.wisc.edu/research/hrpp/hsirbs/wirb.html.
- Minimal Risk IRB reviews primarily research protocols that present minimal risk to subjects and that involve medical interventions or procedures, including medical records research and tissue banking.
- Social and Behavioral Sciences IRB reviews social, behavioral, and non-medical health research.
- Educational Research IRB specializes in education research.
- Marshfield Clinic IRB should be used for investigators based at Marshfield Clinic or using participants or Marshfield Clinic facilities or databases.
- Wisconsin IRB Consortium may allow reciprocal deferral for multi-center protocols among the four IRBs of its members institutions: Aurora Health Care, Milwaukee; Marshfield Clinic; Medical College of Wisconsin, Milwaukee; University of Wisconsin-Madison.
IND/IDE Consultation Service
The ICTR IND/IDE Consultation Service offers expertise, resources, and consultation for investigators needing to interact with the U.S. Food and Drug Administration (FDA). Managing communications with the FDA can often be complex and daunting. Our regulatory experts specialize in helping investigators prepare for FDA interactions and submissions.
The ICTR IND/IDE Consultation Service focuses on providing assistance to researchers during the early stages of research development and maintenance of their INDs and IDEs. Our experts are well versed in regulatory strategy to include the planning, generation, and submission of various types of materials to the FDA (meeting requests, pre-meeting materials, pre-IND materials, IND/IDE applications, Annual Reports, SAE Reports, etc.).
Learn more about the ICTR IND/IDE Consultation Service here.
Office of Clinical Trials (OCT)
The UW Office of Clinical Trials, established in 1988, today offers comprehensive support services to investigators conducting clinical trials (all areas of investigation except oncology) through the UW Institute for Clinical and Translational Research.
The OCT provides services on a fee-for-service basis. In general, regulatory services are provided for a fixed fee, while financial and clinical coordination services are provided at hourly rates.
OCT offers services to investigators regardless of funding source. While the majority of current studies are industry-sponsored, many federal grants, subcontracts, investigator-initiated studies, or foundation-sponsored trials are also supported.
Learn more about the OCT here.
Pharmaceutical Research Center (PRC)
The Pharmaceutical Research Center (PRC) reviews study feasibility, prepares budget estimates, and manages clinical research drug distribution. All clinical drug research protocols within UW Hospital and Clinics must be coordinated through the PRC. For more information, contact the PRC office (608) 263-8902.
Protocol Development Office (PDO)
The Protocol Development Office (PDO) will provide orientation and support to investigators on protocol development before, during, and after research proposal writing. Ideally, this orientation will be provided at multiple points; at the department level, through the research administrators network, as part of educational seminars, and through consultations with investigators and regulatory staff within each department. PDO staff will participate in local scientific review committee meetings and work with departmental research grants offices to identify studies that require protocol development.
Scientific Review Committee (SRC)
The UW-ICTR Scientific Review Committees (SRC) meet twice monthly to review all protocols forwarded to them from the UW Health Science (HS) IRB via ARROW (based on how the applicant addresses the “Scientific Review: Other” section, item 18.1). Protocols reviewed by the SRC include those not reviewed by the Western IRB or by the UW Carbone Cancer Center Protocol Review and Monitoring Committee (UWCCC PRMC). The HS-IRB does not require SRC review of FUNDED protocols with previous scientific reviews (e.g., federally-funded, or foundation-supported projects that have received peer-review).
Learn more about the Scientific Review Committees (SRC) here.
Study Monitoring Service (SMS)
ICTR Study Monitoring Service (SMS) is available to investigators conducting investigator-initiated clinical trials. Not only is independent study monitoring required by the FDA, the NIH (as applicable) and other national and international best practice models (e.g., Good Clinical Practice), it is also a responsibility of the sponsor-investigator to ensure data integrity and the safety of all subjects involved in clinical investigations.
Sponsors typically perform this activity, but when the sponsor is the investigator (as in investigator-initiated trials) this obligation must be fulfilled by the investigator. ICTR Study Monitoring Service can be contracted to help investigators meet their trial monitoring obligations by providing independent oversight of the trial (for the life of the trial) and verifying that the trial is in compliance with the currently approved protocol and applicable regulatory requirements.
More details on SMS here.
ICTR facilitates research within established networks. These networks focus on research studies within Wisconsin, across multiple states, or within specialized communities.
Wisconsin Network for Health Research (WiNHR)
The Wisconsin Network for Health Research (WINHR) supports a statewide clinical and translational infrastructure and offers opportunities for collaborative research between institutions and communities around the state. The four founding partners of WINHR are the UW School of Medicine and Public Health, Marshfield Clinic Research Foundation, Aurora Health Care, and Gundersen Health System. WiNHR was established to promote statewide research and to assist in moving research results from bench to bedside, by allowing investigators to perform clinical, translational, comparative effectiveness and health outcomes research across a variety of platforms. WiNHR also collaborates with sponsors to find optimal sites, patient populations; and investigators to achieve significant clinical research outcomes and maximize the value of research dollars.
Learn more about WiNHR here.
Midwest Area Research Consortium for Health (MARCH)
The Midwest Area Research Consortium for Health (MARCH) provides an established infrastructure for investigators and external sponsors who want to conduct collaborative clinical research at academic institutions across the Midwest. It offers investigators a streamlined mechanism for undertaking multi-site studies.
The MARCH central administrative office is located at the University of Wisconsin-Madison in the Institute for Clinical and Translational Research.
Learn more about MARCH here.
Greater Plains Collaborative (GPC)
UW ICTR is part of the Greater Plains Collaborative (GPC), a new Clinical Data Research Network (CDRN) of 12 leading medical centers in eight states committed to a shared vision of improving healthcare delivery through ongoing learning, adoption of evidence-based practices, and active research dissemination. Partners by state are:
- Indiana, University of Indiana;
- Iowa, University of Iowa Healthcare;
- Kansas, University of Kansas Medical Center;
- Minnesota, University of Minnesota Academic Health Center;
- Missouri, University of Missouri and Children’s Mercy Hospital;
- Nebraska, University of Nebraska Medical Center;
- Texas, University of Texas Health Sciences Center at San Antonio and University of Texas Southwestern Medical Center; and
- Wisconsin, University of Wisconsin-Madison, Medical College of Wisconsin, and Marshfield Clinic.
Learn more about GPC here.
The Wisconsin Research & Education Network (WREN)
The Wisconsin Research & Education Network (WREN) is a statewide primary care, practice-based research network. Researchers may collaborate with WREN when their research involves partnerships with multisite primary care clinicians, practices, and the communities they serve; quality improvement/enhancement; and underserved populations.
For more information please contact:
Wisconsin Research & Education Network
UW Department of Family Medicine & Community Health
1100 Delaplaine Court
Madison, WI 53175
- Population-Based Research Networks