Research Toolkit

Comply with Regulations

Consultations and services

Regulatory support and planning
Regulatory experts from the Clinical and Translational Science Institute (CTSI) can provide assistance navigating the regulatory requirements, such as FDA inspections, clinical trial monitoring, and more. 

Resources

Guide to research compliance
Guidance from the Office of the Vice President for Research (OVPR) on managing compliance issues that arise during the course of a research project.

Data safety monitoring (DSM) guidance
Resources and guidance on the OVPR website that can help you determine if a study needs formal, ongoing monitoring of data to protect research subjects.

Investigational New Drug (IND) or Device Exemption (IDE) resources
Resources on the Food and Drug Administration (FDA) website about administering an investigational drug or biological product to humans. 

IND/IDE assistance
Regulatory experts from CTSI can assist University of Minnesota researchers seeking an IND or IDE for research or treatment.

Export Controls and International Projects Officer
Support and information for University faculty and staff regarding University policy and federal regulations governing technology transfers to non-U.S. personnel, shipments abroad, and international transactions having certain foreign policy and national security implications. 

Contact us

Have a question? Want to schedule a consultation?

Email the Research Navigator

Print this page