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Traumatic Brain Injury

Traumatic Brain Injury Therapeutic Area User Guide v1.0

1.0
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 the CDISC standards, such as CDASH, SDTM, and ADaM.

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.

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