Traumatic brain injury (TBI) is a significant public health problem and is defined as damage to the brain caused by an external mechanical force rather than degenerative or congenital causes. Everyone is at risk for a TBI. It is more common among children and the elderly. Incidence is also higher among men than among women. TBI is a major cause of death and disability worldwide. TBI affects not only those directly injured, but also caregivers and family members.

Traumatic Brain Injury Therapeutic Area User Guide v1.0

Release Date: 2 Dec 2015

Version 1.0 of the Traumatic Brain Injury Therapeutic Area User Guide (TAUG-TBI) was developed under the CFAST Program and the CDISC Standards Development Process. TAUG-TBI describes the most common biomedical concepts relevant to Traumatic Brain Injury, and the necessary metadata to represent such data consistently with TerminologyCDASH, and SDTM.

TA Standards extend the Foundational Standards to represent data that pertain to specific indications within disease areas. CDISC Standards specify how to structure the data; they do not specify what data should be collected or how to conduct clinical trials, assessments or endpoints.

Public Review Comments

CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.

This project was made possible by the generous support of One Mind

CDISC developed a standard for Traumatic Brain Injury under the Coalition for Accelerating Standards and Therapies (CFAST) initiative, a collaboration with C-Path, with expert contribution from members of the TBI Endpoints Development (TED) Initiative and Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) investigator communities, and generous support from One Mind for Research.

The CDISC TBI standards will help catalyze awareness of the types of clinical information that may be relevant to capture, in terms of clinical measures and biomarkers in TBI studies