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Clinical Data
Acquisition Standards Harmonization (CDASH)
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Recent Progress
CDISC
Announces the Publication of CDASH version 1.0
The Clinical Data Acquisition Standards Harmonization
(CDASH) Standard version 1.0 is now openly available
for download
from the CDISC website. You many also access
the CDASH Public Review Spreadsheet
to see the comments that were received during
the review period prior to the release of CDASH
version 1.0.
The published, consolidated CDASH Standard
Version 1.0 document represents a global, consensus-based
standards development process with comments
from organizations in all of the ICH regions
(US, Europe and Japan). It describes recommended
(minimal) data collection sets for 16 domains,
including demographic, adverse events, and other
safety domains that are common to all therapeutic
areas and types of clinical research. The document
also includes implementation recommendations
and best practice guidelines, regulatory references
and other information on the CDASH project.
It is posted openly in the Standards area on
the CDISC website.
Background
This CDASH project is classified as an opportunity
of the FDA Critical Path Initiative, which was
spearheaded by Dr. Janet Woodcock through the
Commissioner’s Office. "This (project)
is an important milestone in the effort to move
to streamlined clinical trial development and
execution by using standardized electronic trial
data," said Dr. Woodcock, who is now the
Director, Center for Drug Evaluation and Research
at FDA.
The CDASH initiative, led by CDISC, supports
clinical and medical research by streamlining
data collection in a way that promotes improved
data interoperability throughout the biomedical
research and product development processes,
and enhances the interface with healthcare and
EHR. CDASH is focused on the development of
consensus-based ‘content standards’--specifically:
element name, definition, and metadata -- for
a basic set of global data collection fields
based on the CDISC SDTM model. The initial scope
of the project, for version 1.0 release published
above, is focused on the ‘safety data
domains’ to support clinical and medical
research and safety reporting.
CDASH was first announced by Dr. Janet Woodcock,
(FDA), at the 2006 DIA Annual meeting. The CDASH
project focuses on the FDA Critical Path Opportunity
#45, and is supported by a collaborative group
of organizations comprised of the Association
of Clinical Research Organizations (ACRO), the
Association of Clinical Research Professionals
(ACRP), the American Medical Informatics Association
(AMIA), Baylor College of Medicine, the Clinical
Data Interchange Standards Consortium (CDISC),
the Clinical Research Forum, the Food and Drug
Administration (FDA), the National Institutes
of Health (NIH), (the Clinical Research Policy
Analysis and Coordination Program, the National
Cancer Institute (NCI-caBIG and NCI-EVS), the
National Clinical Research Resources (NCRR),
the National Library of Medicine (NLM), the
National Institute of Child Health & Human
Development (NICHD)), the Critical Path Institute,
the Pharmaceutical Research and Manufacturers
of America (PhRMA), the Biotech Industry Organization
(BIO), the Society for Clinical Data Management
(SCDM) and Duke Clinical Research Institute.
Since CDISC held the first CDASH project kick-off
meeting in October 2006 where the first three
project streams (domain teams) were initiated,
project participation grew quickly to a total
of 9 streams/domain teams that have worked to
collaboratively develop the collection elements
for 16 safety data domains (adverse events,
concomitant medications, demographics, subject
characteristics, inclusion/exclusion criteria,
medical history, substance use, physical exam,
vital signs, drug accountability, exposure,
comments, protocol deviation, disposition/end
of study, lab and ECG).
Presentations
Webcast in collaboration with DIA
CDASH: Standardizing CRF Data Collection
Fields: An Idea Whose Time Has Come
Originally presented July 24, 2008
View
archive
Next Steps
The next phase of the project is focused on
the collection of feedback from ‘Early
Implementers” of the CDASH standard. All
implementers of the CDASH standard are invited
to send feedback to Rhonda Facile (rfacile@cdisc.org).
Implementation information gathered will be
used to further refine and improve the CDASH
standard.
Contact
For more information on CDASH, and
how to get involved, contact rfacile@cdisc.org.
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