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 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.
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