Regulatory Support

Regulatory Support

The UW Clinical Research Office Regulatory Support unit is a centralized resource offering comprehensive regulatory support services to researchers conducting clinical trials at UW-Madison, UW School of Medicine and Public Health, and UW Health. Regulatory Coordinators aid researchers, research teams, and industry sponsors by delivering enterprise-wide regulatory support, standards, and common infrastructure.

 

CRO Regulatory Coordinators have experience with clinical trials of all phases from multiple disciplines and departments in both pediatric and adult populations. They prepare and manage clinical research applications for hundreds of individual protocols from single site to multi-center oversight projects including sponsored and investigator-initiated clinical trials, NIH-funded Single IRB (sIRB) projects and ceding requests.

 

CRO Regulatory Coordinators steer the clinical research applications through regulatory committee reviews and assist in all aspects until IRB or other approvals are received. They work closely with researchers, clinical research coordinators, financial personnel, and departmental personnel to assure an accurate, complete, and comprehensive submission. CRO Regulatory Coordinators are professional, knowledgeable, organized, and highly skilled and boast a collective 80+ years of research regulatory experience. Our research professionals are skilled in translating and interpreting complex research protocols into plain language that can be understood by a lay audience. Expert staff provide the following, but not limited to, services (as applicable):

 

    • Serves as regulatory contact for research teams and sponsors
    • Analyzing research protocols for clarity, required elements, human subjects protection and ethical provisions, research compliance, and data and safety monitoring plans
    • Translating a research protocol into complete clinical research applications and documents
    • Navigating the UW RELIANT ceding review process
    • Navigating the IRB review process including UW IRBs, commercial IRBs, and other academic institution IRBs
    • Development, editing, and institutionalizing of consent forms
    • Preparing research authorization forms and waivers of authorization
    • Development of participant-oriented materials such recruitment flyers, letters, and screening scripts
    • Management and maintenance of regulatory applications for the life of the project (e.g., initial review through study close out)
    • Preparation and submission of reportable events to the IRB
    • Compliance with federal, state, and university regulatory and policies and procedures
    • Navigating other regulatory committee review processes such as Clinical Research Unit (CRU)

 

CRO Regulatory Coordinators also possess special expertise in compassionate use, emergent, and expanded access program applications to the Food and Drug Administration (FDA) and IRB and serve as a liaison with other institutional resources such as the UW Pharmacy, Pharmaceutical Resource Center (PRC), and Research and Sponsored Programs.

 

CRO Regulatory Coordinators training and certification include:

    • Human Subjects Protection
    • Good Clinical Practice (GCP)
    • HIPAA Privacy and Research
    • VA Privacy and Information Security Awareness and Rules of Behavior
    • Certified Clinical Research Professionals (CCRP®s)

 

CRO Regulatory Coordinators concentrate on clinical research applications for submissions to entities such as:

    • UW ICTR Scientific Review Committee (SRC)
    • UW Institutional Review Boards (IRB)
    • Western Copernicus Group (WCG) IRB
    • Advarra IRB
    • University Hospital ad UW Health Clinics, Clinical Research Unit (CRU)
    • UW Institutional Biosafety Committee (IBC)
    • University Hospital and UW Health Clinics, Research Safety Committee (RSC)
    • University Human Radiation Safety Committees including Human Radiation Use Committee (HRUC) and Radioactive Drug Research Committee (RDRC)
    • Wisconsin Department of Health Services (DHS), Client Rights Office and X-ray Variance (Appendix M)
    • UW Carbone Cancer Center (CCC), Protocol Review and Monitoring Committee (PRMC)
    • Madison Veterans Administration (VA) Research and Development Committee, and other regulatory bodies related to human clinical trials.

Virtual Facility Tour

Tour our facilities and learn about the comprehensive clinical research infrastructure at UW Health and the University of Wisconsin School of Medicine and Public Health.

Questions?