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TBI CDISC Clinical Data Standards Open for Public Review and Comment

Expert contributions from members of the TED and TRACK-TBI investigator communities, with generous support from One Mind

 

Posted August 14, 2015

 

SAN FRANCISCO, CA – August 14, 2015  The new TBI CDISC (Clinical Data Interchange Standards Consortium) clinical data standards are now open for public review and comment. This 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 TED and TRACK-TBI investigator communities, and with generous support from One Mind. CDISC has developed industry-wide data standards enabling the harmonization of clinical data and streamlining of research processes from protocol (study plan) through analysis and reporting.

The CDISC TBI standards will help catalyze awareness of the types of clinical information that may be relevant to capture, both in terms of clinical measures and biomarkers in TBI studies. Please review and comment by following the links below.

Comments Due 21 September 2015
These documents are located on the CDISC Portal and can be accessed by clicking here. The TBI document is called TAUG-TBI v1draft.

Instructions on using the Public Review Comment Tracker can be found here.




 

 

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About UCSF
UCSF is the nation's leading university exclusively focused on health. Now celebrating the 150th anniversary of its founding as a medical college, UCSF is dedicated to transforming health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It includes top-ranked graduate schools of dentistry, medicine, nursing and pharmacy; a graduate division with world-renowned programs in the biological sciences, a preeminent biomedical research enterprise and two top-tier hospitals, UCSF Medical Center and UCSF Benioff Children's Hospital San Francisco.

About One Mind
One Mind is an independent, 501(c)(3) non-profit organization dedicated to benefiting all affected by brain illness and injury through fostering fundamental changes that will radically accelerate the development and implementation of improved diagnostics, treatments, and cures; while eliminating the stigma. One Mind believes in open science principles and creates global public-private partnerships between governmental, corporate, scientific, and philanthropic communities. Visit us at www.onemind.org or follow us via Twitter or Facebook.

CONTACT
Brooke Whitney
Office: +1 206.946.1768
brooke.whitney@onemind.org