CTSI Support of TR01 grants and Large-grant RFAs

The Clinical and Translational Science Institute of the University of Minnesota aims to serve as a catalyst for clinical translational research through dissemination of funding opportunities (both federal and industry), serving as support teams for investigators seeking grants and contracts and providing proactive support in the preparation of grants and contracts. 

CTRS research staff will provide comprehensive, effective and efficient clinical, biostatistical, regulatory, informatics, financial and project management support for investigators. Teams of CTRS research staff will be formed to address project needs, design trials and protocols, establish work plans, assure regulatory compliance, enable project initiation and completion and provide data management, analysis and reporting.

Specifically, CTSI staff will provide the following services to selected groups seeking to apply for TR01 and Large-grant RFAs (pre-award support):

Biostatistical Support:
The Biostatistical Design and Analysis Center (BDAC) will assist investigators in study design development, sample size analysis, development of a statistical analysis plan and data management design.  If a multi-center trial is involved, plans for data coordinating center support will be provided.

Regulatory Support:
The Regulatory Knowledge and Support Function (RK&S) will provide support for the design of data monitoring plans and when necessary, data monitoring committees, development of investigational new drug/investigational device exemption applications, and appropriate regulatory documents.

Clinical Research Implementation Support:
The Clinical Research Implementation Services Function (CRIS) will assist with clinical trial design, development of study methodologies, assessment of services needed for study completion, determination of appropriate staffing for research conduct and facilities needed for the clinical trial.  In addition, CRIS staff will also assist in determining availability of appropriate study populations and recruitment methodologies.

Financial/Administrative Support:
CTSI financial staff will assist in budget preparation (with consultation from the groups listed above), biosketch collection and collation, preparation of supporting materials, collecting letters of support, grant compilation and submission.

It is anticipated that CTSI will support the submission of 4-5 of these types of grants prior to the February submission cycle. If more requests for support are received than staff to support the efforts, the Administrative Review Committee of Clinical Translational Research Services will assess the merits of the applications and select the most meritorious for support.  It is anticipated that whenever possible, investigators will plan for and utilize CTSI services for post-award implementation of the awarded grant.