Regulatory Support
CTSI provides expert assistance navigating regulatory requirements for clinical and translational research, including support for:
ClinicalTrials.gov submissions
Investigational New Drug (IND) and
Investigational Device Exemption (IDE) applications
COVID-19 update: Our clinical trial monitors are able to perform site visits in-person or remote. We encourage all study teams to provide applicable study materials in an electronic format when feasible. If you are unable to provide study materials electronically, we will schedule an on-campus visit to review your study materials.
For questions, please contact Kelly McCormick at [email protected] or your assigned monitor.
Clinical trial monitoring
CTSI's clinical research associates (CRAs) assist investigators with regulatory compliance. Monitors review study materials (documents, records, drug/device accountability, Case Report Forms, etc.) to assure that the study is conducted, recorded, and reported in compliance with FDA Good Clinical Practice.
CRAs will also ensure that the study is conducted in accordance with the protocol and inclusion/exclusion criteria as approved by the IRB. CTSI monitoring services are provided at no cost to University of Minnesota investigators. Our goal is to promote and facilitate compliance with Good Clinical Practice through:
- Regular monitoring visits
- Quality assurance
- Data query resolution
- Review of study regulatory files
- Adverse Event/Serious Adverse Event (AE/SAE) reviews
- Compliance consultation services
- Typical review of subject specific documents includes but is not limited to:
- Signed informed consent/HIPAA documents
- Case Report Forms (CRFs)
- Medical records (for AE/SAE)
- Regulatory binders
- Communications with FDA/IRB
- Investigational Product (IP) distribution logs
Regulatory specialists
CTSI’s regulatory specialists provide guidance and support for clinical trials ranging from navigating the IRB submission process to maintenance of study documents (regulatory binder/ Investigator Site File).
The regulatory specialists help ensure your study files follow Good Clinical Practice guidelines, can help reduce the number of common stipulations on your IRB submissions, and can identify other useful resources for your specific study.
Types of support include:
- Completion of start-up materials only (IRB submission start-up through initial approval)
- Ongoing IRB document completion, such as submitting report forms, summarizing study changes, etc.
- Consultation on IRB submissions and regulatory document maintenance
Consult with an expert
Sydney Viel
Regulatory Specialist Manager
[email protected]
Melissa Hansen
Research Navigator
[email protected]
612-625-CTSI (2874)