"Tennessee's state-wide multi-site clinical trial facilitator - Site operated, academically supported, powered by a robust research enterprise data warehouse, for superior performance and increased sponsor engagement."
Who We Are
PIs must recruit and create the best studies available, and at the same time ensure rapid start-up and profitability of trials. Academic affiliation and university participation are the best way to ensure the former, while individual institutions have historically been more accomplished in expediting study start-up and profitability.
The Clinical Trials Network of Tennessee (CTN2) was created, as a 501(c)(3) subsidiary of UT Research Foundation (UTRF), governed by a Board representing participating institutions, including hospital systems and large practice plans, to enhance, state-wide multi-site clinical trials involving the University of Tennessee Health Science Center (UTHSC) faculty, participating hospitals and our practice plans and to ensure UTHSC receives credit for the research it conducts. CTN2 leverages the best of both worlds to provide university-based credibility and recruitment opportunities while employing expert contract capabilities geared to enabling rapid, hospital-led study start-up – to supplement rather than compete with current institutional resources, engaging more sponsors for more trials.
STRUCTURE & CONTRACTS
CTN2 is a 501(c)(3) Tennessee non-profit corporation, organized as a subsidiary of UTRF, the sole corporate member. CTN2 is governed by a Board of Directors which includes a representative from each participating hospital, nominated by the hospital and elected by UTRF.
CTN2 markets its network of participating hospitals and practice groups, and access to TN-EDW and statewide trial patients to clinical trial sponsors.
To accommodate the source of clinical trials within each participating hospital and practice group, CTN2 can contract in one of two ways:
Where CTN2 is the contractor, the clinical trial sponsor contracts directly with CTN2. CTN2 sub-contracts with participating hospital or practice group via a Master Clinical Trial Agreement (MCTA) to streamline contract execution while preserving trial specific negotiations utilizing exhibits to the MCTA that includes Statement of Work, Budget, and List of Exceptions to Terms and Conditions of the trial.
Where the participating hospital or practice group is the contractor, CTN2 is a party to the contract in order to provide a mechanism for UT to account for research expenditures related to trials.
In both contracting options, clinical trial sponsor funding flows through CTN2 to participating institutions and down to practice plans. CTN2 may charge a network fee, as established by the Board, to cover administrative costs.