The new CDISC (Clinical Data Interchange Standards Consortium) conformed NINDS TBI Common Data Elements (TBI-CDEs) are now open for public review and comment. The conformed data standards, contained in the Therapeutic Area Data Standards User Guide for Traumatic Brain Injury (TAUG-TBI) was developed under the Coalition for Accelerating Standards and Therapies (CFAST) initiative, a collaboration with C-Path, with expert contribution from members of the TRACK-TBI and TED investigator communities, and with generous support from OneMind.
News
August 14, 2015
July 22, 2015
In a collaborative effort, TRACK-TBI and TED Investigators drafted two responses to the FDA's Request for Information on Identifying Potential Biomarkers for Qualification and Describing Contexts of Use to Address Areas Important to Drug Development. Responses on the potential of blood-based and MRI biomarkers in TBI were submitted.
To read the response on Blood-Based Biomarkers, click here.
February 13, 2015
The TBI Endpoints (TED) Initiative held its first Consensus Conference on February 2-3, 2015 at the NIH campus in Bethesda, MD. The TED Initiative, a five-year program funded by the U.S. Department of Defense, will curate and harmonize data from a variety of legacy and ongoing military, civilian, and sport TBI cohorts into a Metadataset that can be interrogated for associations between clinical, proteomic, genomic, and imaging findings that smaller individual studies were not powered or designed to find.
November 05, 2014
Within 1 year of study launch we have enrolled our 500th patient.
