Clinical Research Support Center
The CRSC brings resources together in one location to help researchers and study teams with the administration of a research study from project readiness/feasibility assessment through project initiation.
The University of Minnesota's primary clinical research service groups along with University of Minnesota and Academic Health Center senior leadership, and the University of Minnesota clinical research community have collaborated on a new center for researchers and study teams aimed at reducing study start-up timelines and hurdles across the complex, ever changing clinical research environment.
The Clinical Research Support Center (CRSC) is a collaboration among CTSI, the Office of the Vice President for Research, Fairview Health Services and University of Minnesota Physicians that provides a new cross-functional team-based approach to guide and support University of Minnesota clinical researchers and study teams.
Subject manager experts from across more than 20 functional clinical research service groups are co-located in the Bio-Medical Library (Diehl Hall) and available to provide research facilitation assistance during the study start-up process and to streamline research processes, including budgeting, contracts and IRB guidance.
- IND/IDE determination and application support
- IRB submission preparation support and clarification
- Clinical consultation and pricing from Fairview Health Services and/or University of Minnesota Physicians
- Budget development
- Contract negotiation assistance
- Protocol development
- Project plan guidance
- Cohort identification and study feasibility Informatics consultation
- Clinical, genomic and biospecimen data access
- Sample size calculations
- Statistical analysis
- Study feasibility / project readiness
- Engaging community members in study development, recruitment, and implementation
- ClinicalTrials.gov entry and updates
- Fairview Health Services recruitment approvals
- OnCore support
- REDCap assistance
- Clinical Trial Agreement and Material Transfer Agreement assistance
CTSI resources available through the CRSC can also help on through recruitment, execution, study close-out, and publication.
The new center is supported by institutional leadership and a diverse steering committee, and its processes and offerings have been informed by more than 140 individuals across the U of M clinical research community over the last 20 months. CTSI is leading the implementation and ongoing management of the CRSC on behalf of the collaborative group.