FUNCTIONS & BENEFITS
Benefits of Participating
All CTN2 participating institutions may elect to participate at no additional cost. Trials could involve one, multiple or all participating institution sites. Participating institutions and sponsors have access to one-stop shopping with CTN2 providing contracting, billing, and IRB services. TN-EDW data on potential clinical trial participants allows clinical trial sponsors efficient assessment of and access to multiple Tennessee participating institutions and clinical care networks.
CTN2 offers trial participation on a nonexclusive basis; participating hospitals remain free to contract directly with sponsors when that is deemed advantageous. Economies of scale made available by the participation of Tennessee's leading clinical research institutions, and CTN2's facility in contracting, is expected to attract more sponsors and more trials.
Each participating institution has a seat on the CTN2 Board. Additionally, CTN2 will allow for the highest level of individual Pl and participating institution control over research activities. Board-specific approval of particular projects is required only for studies that require resources beyond those provided by external funding. This allows for continued strategic control of projects by PIs and each participating hospital.
UTHSC benefits from this arrangement also. As a University component, UTRF and its subsidiaries' research expenditures are included in UT's annual NSF HERD Survey response. This structure allows UT to account for research expenditures related to trials, improving UT's ranking and reputation and making participating hospitals, practice plans, and medical school more attractive in recruiting and retaining research professionals and trial sponsors. In addition, increasing the sources of data to include a network of participating hospitals further enriches TN-EDW as an academic research tool.
TENNESSEE ENTERPRISE DATA WAREHOUSE (TN-EDW)
A state-wide Tennessee Enterprise Data Warehouse (TN-EDW) provides data resources for CTN2. Developed by UTHSC, TN-EDW encompasses:
Data from each participating hospital is extracted and placed into a common data model (CDM). The CDM ensures that data from each participating hospital is consistently aligned and represented, compatible with large network formats such as OHDSI-OMOP, Sentinel Initiative or PCORNET;
Data from each participating hospital is derived from all its contributing EMRs. For example, data is extracted from Cerner, Epic, Allscripts, eClinical, OncoEMR, or other vendors, shared with TN-EDW and then transformed into a CDM format. This data matures over successive iterations to include not only all structured data but also unstructured data (free text), image data, and genomic/omic data;
A de-identifiable version of TN-EDW is available for preparatory-to-research type queries. Examination of the de-identified data for such prep-to-research queries will be accessible by UT investigators via visualization processes such as Tableau, i2b2, PRD (Pediatric Research Datamart), or similar;
Remote access to TN-EDW to third parties, such as TriNetX, exists for the purpose of generating simple data counts (to assess, for example, numbers of eligible patients for a clinical trial) after necessary business arrangements have been signed off by all parties.
Contracting & Billing
Using the CTN2 framework, additional expertise in Contracting and Billing beyond that currently available within most participating hospitals is provided for participating studies. With dedicated expertise and management systems in solicitation response, rapid drafting and execution of contracts, participating hospitals are free to use these resources in conjunction with their grants office to streamline and expedite processes.
Internal Review Board
To promptly obtain all required human subject approvals for multi-site Clinical Trials, CTN2 facilitates regulatory review per local and institutional regulations, consistent with the preferences of PIs, participating hospitals, and funding sources via an appropriate Internal Review Board.
As a subsidiary of UTRF, CTN2 arranges for PIs and participating hospitals access to UTRF’s established Intellectual Property protection and commercialization process, staff expertise, marketing reach, and assistance in bringing intellectual property from “concept to market.”