CRIX: toward a secure, standards-based, clinical research information exchange.
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CRIX: CRIX: toward a secure, standards-based, toward a secure, standards-based, clinical research information exchange clinical research information exchange
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Transcript of CRIX: toward a secure, standards-based, clinical research information exchange.
CRIX:CRIX: toward a secure, standards-toward a secure, standards-
based, clinical research based, clinical research information exchangeinformation exchange
Page 2CRIX Overview
Bioinformatics Goals - Bioinformatics Goals - IOTFIOTFBioinformatics Goals - Bioinformatics Goals - IOTFIOTF
Address common interests of FDA and NCI - Develop process for cancer community IND e-
CTD submission- Improve the process for reporting adverse
events, investigator information, and financial disclosure information
- Standardize terminology
Page 3CRIX Overview
What is CRIX?What is CRIX?What is CRIX?What is CRIX? An open collaborative effort to build a Clinical
Research Information Exchange (CRIX) with participants from among government, industry and academia:- caBIG Community- Industry – PhRMA and BIO representatives- Standards Community – CDISC, HL7, SAFE- Patient Advocates – Patient Advocates for Research- Government – NCI (CTEP, DCP, NCICB) initially, expanding to
other NIH institutes and other agencies in next phase
* FDA in special, independent role as provider of requirements, policies, and regulations
Page 4CRIX Overview
CRIX Strategic GoalsCRIX Strategic GoalsCRIX Strategic GoalsCRIX Strategic Goals Sustainable, secure and standards-based
infrastructure for electronic submissions Global Investigator Registry for commonly
used/referenced data Facilitator and implementer of information
exchange standards Mechanism for secure electronic information
exchange Legally enforceable digital signatures compliant
with Title 21 Regulations and other guidelines from the outset
Page 5CRIX Overview
CROs(industry/Academia/Govt)
RegulatorsBio-Tech/Pharmaceutical/ Medical Device Mfrs
Regulated Data Flow
RegulatedDataFlow
CRIXCRIX
Regulated Data Flow
Global
Data
Sources
Investigators/Physicians(Industry/Academia/Govt)
Regulated
Data
Flow
RegulatedDataFlow
CRIX VisionCRIX VisionCRIX VisionCRIX Vision
Page 6CRIX Overview
Transitioning to CRIX Transitioning to CRIX VisionVisionTransitioning to CRIX Transitioning to CRIX VisionVision
Start with small strategic pilots Leverage existing international standards and data models
- CDISC Operational Data Model (ODM) Study Data Tabulation Model (SDTM)
- HL7 messaging
- FDA Janus model
- SAFE Identity Management
Evaluate and extend existing NCI infrastructure- CTEP/DCP
- caCORE
Leverage caBIG developments Open source, open standards, open architecture, open access, open
development
Page 7CRIX Overview
CRIX Development CRIX Development StrategyStrategyCRIX Development CRIX Development StrategyStrategy
Component 1Component 1
Component 2
Component 2
Component x
Component x
CRIX 1.0 CRIX 2.0 CRIX x.0
technicalfeasibility
operationalfeasibility
…
…
ProductionInfrastructure
Infrastructure Development
Page 8CRIX Overview
CRIX 1.0: Project FirebirdCRIX 1.0: Project FirebirdCRIX 1.0: Project FirebirdCRIX 1.0: Project Firebird Firebird (Federal Investigator Registry for
Bioinformatics Research Data):- Automating and centralizing the 1572 registration
process- Enabling investigators to register online with NCI and
other sponsors, including commercial sector- Leveraging SAFE (“Secure Access For Everyone”)
standard for legally enforceable digital signatures- Developing a standard for 1572 information- Proving the feasibility and value of the Mission
Phoenix concept
Page 9CRIX Overview
CRIX: Next StepsCRIX: Next StepsCRIX: Next StepsCRIX: Next Steps Develop and test maturation process for
deploying production CRIX components- Broad community engagement- Sustainable production support
Develop and pilot test additional CRIX components – possibilities:- Protocol registry- eIND (starting with NCI)- Standardized CRFs- Janus data warehouse, data marts, analysis tools
Page 10CRIX Overview
Production Infrastructure - Production Infrastructure - Principles Principles Production Infrastructure - Production Infrastructure - Principles Principles
Assembles, maintains, and extends pilot components
Open, transparent, inclusive, governance- Government- Academics- Industry
Management through trusted 3rd party- Hosting services- Managing the SAFE credentialing process- Managing Site Registry, Organization Registry,
Investigator Registry Self sustaining
Page 11CRIX Overview
More informationMore informationMore informationMore information
List Serve:
- This is an open list server and involves key stakeholders, product vendors and anyone else who wishes to subscribe to keep informed of activities and progress.
Page 12CRIX Overview
AcknowledgementsAcknowledgementsAcknowledgementsAcknowledgements
And so many more…
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