CRIX: toward a secure, standards-based, clinical research information exchange

Page 2 CRIX Overview Bioinformatics Goals - IOTF  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 3 CRIX Overview 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 4 CRIX Overview CRIX 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 5 CRIX Overview CROs (industry/Academia/Govt) Regulators Bio-Tech/Pharmaceutical/ Medical Device Mfrs Regulated Data Flow Regulated Data Flow CRIX Regulated Data Flow Global Data Sources Investigators/Physicians (Industry/Academia/Govt) Regulated Data Flow Regulated Data Flow CRIX Vision

Page 6 CRIX Overview Transitioning to CRIX Vision  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 7 CRIX Overview CRIX Development Strategy Component 1 Component 2 Component x CRIX 1.0 CRIX 2.0 CRIX x.0 technical feasibility operational feasibility … … Production Infrastructure Infrastructure Development

Page 8 CRIX Overview CRIX 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 9 CRIX Overview CRIX: 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 10 CRIX Overview Production Infrastructure - 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 11 CRIX Overview More 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 12 CRIX Overview AcknowledgementsAcknowledgements And so many more…