CDISC and Cohen Veterans Bioscience Announce Public Review for Post Traumatic Stress Disorder Therapeutic Area User Guide

20-Sep-2017 Intellasia | BusinessWire | 10:48 PM Print This Post

AUSTIN, Texas–(BUSINESS WIRE)–The
Clinical Data Interchange Standards Consortium
 (CDISC) and Cohen
Veterans Bioscience
announce the availability of a Post Traumatic
Stress Disorder Therapeutic Area User Guide (TAUG-PTSD) for public
review.

The TAUG-PTSD v1.0 describes how Post Traumatic Stress data should be
recorded in a standardized database, establishing best practices across
the clinical research industry for recording, reporting, and sharing
relevant, disease-specific metadata and research data. Use of the
standard will facilitate regulatory submissions for novel therapies. It
will also allow the research community to compare and contrast data from
different studies more easily, with more scientific rigor, and will make
it easier for researchers to understand natural history, biomarker, and
trial data in the future.

TAUG-PTSD v1.0 describes the common biomedical concepts relevant to PTSD
studies using the CDISC standard format. Concepts covered in the
TAUG-PTSD v1.0 include representation of skin conductance, startle
response, and sleep data. Questionnaires, Ratings, and Scales of
interest for PTSD studies are also referenced in this user guide.

Researchers and clinicians are encouraged to review TAUG-PTSD v1.0 and
provide feedback. CDISC relies on input from the clinical research
community to ensure neutral, consensus-based data standards are
developed and adopted by diverse global stakeholders interested in
improving research processes and quality for the benefit of all.

To review the user guide, please visit: PTSD
Public Review

CDISC invites you to attend
the webinar for the PTSD Public Review
26 SEP 2017 10 AM – 11 AM CDT.

The review period for the TAUG-PTSD v1.0 runs through 13 NOV 2017.

PTSD is a clinically diagnosed psychiatric condition that can occur
following the experience or the witnessing of life-threatening events,
such as military combat, natural disasters, terrorist incidents, serious
accidents, or physical or sexual assault in adulthood or childhood. Not
everyone exposed to a traumatic event will develop PTSD. According to
the United States National Center for PTSD, about 7 or 8 out of every
100 people will experience PTSD at some point in their lives.

“The fast-paced development of this PTSD data standard by the CDISC team
was critical for empowering the next wave of data collection and sharing
by the global research community and will save time and resources to
unlock cures sooner,” commented Dr. Magali Haas, CEO & President, Cohen
Veterans Bioscience.

TAUG-PTSD v1.0 was funded by Cohen Veterans Bioscience and developed
through the Coalition for Accelerating Standards and Therapies (CFAST)
initiative, a partnership of CDISC and the Critical Path Institute
(C-Path), with participation from the U.S. NIH National Cancer Institute
Enterprise Vocabulary Services (NCI-EVS), FDA, TransCelerate, the Japan
Pharmaceutical and Medical Devices Agency (PMDA) and additional
stakeholders.

To date, therapeutic area standards have been developed for more than 30
different disease areas.

About CDISC

CDISC is a 501(c)(3) global nonprofit organization that develops data
standards to foster smarter research. CDISC standards allow data to speak
the same language
by providing common formats for data collection,
data sharing and data analyses to make the most of the valuable
information offered by patients participating in research studies around
the globe, enabling researchers to discover new treatments, find
breakthroughs, and unlock cures. CDISC standards are required for
regulatory submissions to the US FDA and Japan PMDA, endorsed by the
China CFDA, and requested for use by the European Innovative Medicines
Initiative (IMI). The suite of CDISC standards is freely available on
the CDISC
website
.

CDISC is funded through the generous support of over 400 member
organizations from pharmaceutical, biotech, clinical research
organizations, regulatory agencies, academia, and healthcare, as well as
through grants, authorized CDISC Education courses, events, and
charitable contributions. To find out more about how to support CDISC
and get involved, please visit www.cdisc.org.

About Cohen Veterans Bioscience

Cohen Veterans Bioscience is a national, nonpartisan 501(c)(3) research
organization dedicated to fast-tracking the development of diagnostic
tests and personalized therapeutics for the millions of veterans and
civilians who suffer the devastating effects of trauma-related and other
brain disorders. To support & learn more about our research efforts,
visit www.cohenveteransbioscience.org.

Contacts

CDISC
Ann P. White, 512-363-5826
awhite@cdisc.org

 


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