QuesGen Systems is the Data Management platform for TRACK-TBI.
QuesGen was selected for several significant TBI and other neurology-related projects, for which QuesGen developed a large library of electronic Case Report Forms (eCRFs) And neurocognitive assessments.
RELATIONSHIP
QuesGen has worked with TRACK-TBI since 2010
STUDY SIZE
3,700 participants to date
STUDY SITES
18 clinical data collection sites
Overview
QuesGen was selected for several significant TBI and other neurology-related projects, for which QuesGen developed a large library of electronic Case Report Forms (eCRFs) and neurocognitive assessments.
Clinical, imaging, proteomic, genomic and clinical outcome databases will be linked into a shared platform that will promote a model for collaboration among scientists within InTBIR and elsewhere, which was originally funded by the Grand Opportunity Grant (GO study).
- Enrolled over 3,700 participants to date, including ortho controls and friend controls
- 18 clinical data collection sites
- Infrastructure of integrated databases, imaging repositories, and biosample repositories
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About TRACK-TBI
TRACK-TBI is built from the foundational NINDS-funded TRACK-TBI Pilot study, which collected clinical data from 3 sites and 600 subjects.
With more than fifteen publications and growing, the TRACK-TBI Pilot dataset is the first to populate the Federal Interagency Traumatic Brain Injury Research (FITBIR) repository and with the current TRACK-TBI data, is compatible with the International Initiative for Traumatic Brain Injury (InTBIR), a collaborative effort of the European Commission (EC), the Canadian Institutes of Health Research (CIHR) and the National Institutes of Health (NIH).
The global aim of this project is to test and refine Common Data Elements (CDEs), neuroimaging standards, and best practices for genetics and proteomics in TBI studies.
The investigators anticipate that this project has the potential to substantially advance and revolutionize clinical research in TBI. Repositories for neuroimaging, proteomic, and genetic biomarkers will facilitate the evolving field of these emerging technologies in TBI. TRACK-TBI also forms one of the core datasets of the Department of Defense-funded TBI Endpoints Development (TED) Initiative, which has established an interrogatable Metadataset of high-quality studies across civilian, sports, and military populations.
TED’s (TBI Endpoints Development Initiative) goals, aligned with TRACK-TBI, are to identify and validate the FDA regulatory readiness of candidate clinical outcome assessments and proteomic and neuroimaging biomarkers and technologies that may serve as endpoints in the design of precision clinical trials.
To date, there are 76 TRACK-TBI publications, with additional articles expected in the future.