Regulatory Knowledge and Support
CTSI provides a single access point to clinical translational science regulatory and compliance support services, including assistance with:
- IRB processes
- Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications
- Clinical Trial Monitoring
- ClinicalTrials.gov submissions
- Good manufacturing practice (GMP)
For future development we aim to:
- Further consolidate informational and support services for regulatory and compliance requirements to better assist investigators in conducting CTS research.
- Establish a collaborative IRB review process with community institutional partners and develop a process for creating a transformative, multi-institutional IRB review process to facilitate and streamline the implementation of multi-site studies.
- Provide regulatory support to community-based researchers and staff based on co-identified needs, which is appropriate for the type of research being conducted.
- Offer educational opportunities regarding regulatory issues in a flexible and tailored format to facilitate regulatory understanding and compliance both at the UMN and in the community.
