About CRIX
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“Faced with rapid changes, the nation’s
healthcare system has fallen short of its ability to translate information
into knowledge that can be used in practice, and to apply new technology
safely and appropriately.
The results are exactly what you would expect. Everyone who uses
the current system constantly confronts large information gaps,
whether it’s at the doctor’s office, on the hospital
ward or at government agencies charged with protecting the public
health. That goes for the FDA -- we’re no exception. You can
still find medical reviewers huddled in their offices between the
15 boxes that it took to ship a new drug application. There’s
still too much paper at FDA -- we’re a fire hazard.
This is bad for FDA, it’s bad for many of your businesses,
and most importantly it’s bad for patients. We need to fix
it. The kinds of information bottlenecks created by poorly accessible
paper records is dangerous, inefficient and expensive, whether it’s
our own evaluation of a new drug application, or a doctor’s
evaluation of her patient.”
Dr. Mark McClellan, former FDA Commissioner
CDISC Interchange, October 2003
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Technology can enable a quantum leap forward in the development, testing, and
approval of new drugs so that they can be delivered more quickly to people who
need them.
Recognizing the problem and the opportunity, the National
Cancer Institute (NCI) has joined other Federal agencies, academia, industry,
standards organizations, and patient advocates to develop a common electronic
infrastructure for regulatory data and document submission, review, and analysis.
This initiative—the Clinical Research
Information Exchange (CRIX)—is
led by the National Cancer
Institute Center for Bioinformatics (NCICB).
Specific CRIX products will include:
- Sustainable, secure and standards-based infrastructure for electronic submissions
- Standards-based repository for data analysis and review
- Global registry for commonly used/referenced data
- Common information exchange standards
- Mechanism for secure electronic information exchange
- Legally enforceable digital signatures compliant with Title 21 Regulations
and other guidelines from the outset
CRIX will adhere to the NCICB’s cancer
Biomedical Informatics Grid™ (caBIG™) principles of standards-based,
open source, open access, and open development. CRIX products and components
will be developed to the caBIG™ Silver level of compatibility.
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Created by
admin
Last modified
2006-03-08 03:04 PM
