Regulatory Services

Comprehensive Regulatory Support

The CTI Regulatory Support Unit is a centralized resource offering expert regulatory services to researchers across UW–Madison, UW School of Medicine and Public Health, and UW Health. Our experienced team supports clinical trials of all phases and types—from single-site studies to multi-center, NIH-funded projects.

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About

What We Do

Our Regulatory Coordinators provide end-to-end support for clinical research applications, including:

- Serving as the primary regulatory contact for research teams and sponsors
- Translating complex protocols into complete, compliant applications
- Navigating IRB and ceding review processes (UW RELIANT, commercial IRBs, academic IRBs)
- Developing and editing consent forms and participant-facing materials
- Preparing research authorization forms and HIPAA waivers
- Managing regulatory applications from initial submission through study close-out
- Submitting reportable events to the IRB
- Ensuring compliance with federal, state, and institutional regulations
- Coordinating with other regulatory committees (e.g., CRU, PRC, IBC, RSC, HRUC, RDRC)

Special Expertise

We offer specialized support for:

- Compassionate Use & Expanded Access Programs
- FDA Emergency Use Applications
- Liaison Services with UW Pharmacy, PRC, and Research & Sponsored Programs
- Global Clinical Research Studies

Training and Certification

Our team holds certifications and training in:

- Human Subjects Protection
- Good Clinical Practice (GCP)
- HIPAA Privacy & Research
- VA Privacy & Security
- Certified Clinical Research Professionals (CCRP®)

Regulatory Entities We Work With

We support submissions to a wide range of regulatory bodies, including:

- UW IRBs & ICTR Scientific Review Committee (SRC)
- Commercial IRBs (Advarra, WCG)
- UW Health Clinics & Clinical Research Unit (CRU)
- UW Institutional Biosafety Committee (IBC)
- UW Research Safety Committees (RSC, HRUC, RDRC)
- Wisconsin DHS (Client Rights Office, Appendix M)
- UW Carbone Cancer Center PRMC
- Madison VA Research & Development Committee