1. 1 caBIG®-aligned Enterprise Metadata Infrastructure to Support Commercial Clinical Trials Management Software: A Pilot Implementation September 11, 2009

2. 2 Background Clinical Trials Management Roadmap M.D. Anderson is adopting a commercial application (Velos eResearch) as the enterprise clinical trials management software. (CTMS) As an NCI-funded cancer center, we recognize the importance of adopting NCI data standards for data acquisition, and data sharing on the cancer bioinformatics grid. In order to optimize data sharing within our institution, and also align ourselves with external data initiatives, we are in the process of developing enterprise specific data standards which would underlie our clinical research applications, clinical care applications, translational research applications, and administrative applications..

3. 3 Focus Our goal: We have focused on developing an enterprise metadata infrastructure to provide data standards for information acquisition and harmonization no matter what application is being used to collect that information. Applications of note: ClinicStation Velos eResearch Source Systems like lab, radiology, etc.. Research database collection systems Translational Research Platform (TREX) Administrative Warehouse

4. 4 Issues with caBIG: (From OSU) No support for “local” metadata or terminologies/ontologies. Can’t or not intended to stand up a “local” caDSR. The annotation tools and caDSR cant annotate or store a model that is annotated by more that one metadata registry. Hard to or can’t copy content from NCI caDSR to your own caDSR. caGrid tools currently can only create grid data services that use models which have gone through the SIW so currently need to use the above NCI source of metadata approach. “borrowed” from OSU presentation!

5. 5 Issues with MDACC! Not a model driven application development shop In-house developers have no experience with UML No Model Repository underlying applications Complex enterprise with HUGE research initiatives Unable to scale a centralized metadata management initiative Very strong research domains with “selfish” interests No “tradition” of enterprise modeling

6. 6 Research Data Matrix MDACC D&DS Repository Department Data Service Institutional Data Services VELOS HRPP-AE Regulatory & Compliance (MicroStrategy ) Grants & Contracts Sponsor/ Registry Reporting Biostatistics Lab Path Scheduling ADT ClinicStation other (Research team Data entry) Key concepts: interoperability enter once – use often SOA

7. 7 Velos eResearch My Velos User Configuration System Configuration Network Configuration Velos eResearch Console Alerts/Reminders Scheduling Status Management Patient/Data Safety Mgmt. Patient Management Financials Budgets Milestones Forecasting Revenue/cost Mgmt. Application Generator On-line Forms Study Specific Forms Application Extensions Site Specific Apps System Integration Third Party Systems In-house Systems Sites Velos eResearch

8. 8 Velos eResearch Technology Overview Web-based Open, secure, scalable architecture Multi-tiered J2EE compliant application Powerful Interface Engine technology Compliant with standards (HIPAA, CFR Part 11, CDISC, NCI, HL – 7 etc.) Multiple dictionary support (ICD-9, CPT, LOINC, NCI CDE, NCI CTC, Site-specific etc.)

9. 9 Limitations of Velos eResearch eResearch Has the concept of “libraries” Has a data element dictionary – Each element has certain attributes No Vocabulary binding – one description field box to give a description of what the data element is. Can import caDSR “shopping cart” XML Limited Data Element searching Limited Review capabilities Limited Domain partitioning Limited use/rights No controls on data element duplication Etc..

10. 10 Velos: caDSR Integration

11. 11 Velos Data Element Creation

12. 12 Data element browsing

13. 13 Velos Standards Repository Pilot Problem: No governance for data element management Lack of infrastructure for data element creation and maintenance No “controls” for management of data elements We heard from other uses about the criticality of preventing Data element “creep” and “duplication”

14. 14 Enterprise Vision Need to abstract the Data element management out of the Velos Application so that our other applications can utilize these same “enterprise” standards Our homegrown EMR is building a structured data collection module and we would like to utilize a common infrastructure Need enterprise capable infrastructure to support federated metadata management at the application level, research domain level, at the enterprise level, and ultimately at the national level

15. 15 ADT Lab Dept. Sys CTMS Velos MDA DSR MDA Data Standards Repository provides CDEs Web Service Directory RR Reporting Copy RR Subject Area Data Warehouse EIW Replication or ETL Data from Transactional Systems to RR / Reporting / Data Warehouse Environments Federated Research Data Repositories w/ all historical data and real-time and near-time data feed Support Analytics across clinical research and translational research Dashboard Applications Report to external entities FDA (HL7 v3 RIM message), CDUS, NCI, Pharma, etc. Logical model beneath each application conform or map to MDA Enterprise Information Model … National Domain Analysis Models: BRIDG, HL7 v3 RIM National Data and Vocabulary Standards: caDSR, EVS, SNOMED, CDISC, etc. Align and Map UDDI Publish or Search Vocabulary Service Group SOA Governance Data Modeling HRPP Service and stores Gateway stores and transactional stores MDA Data Standards Repository (DSR) and Research Data Repository (RDR)

16. 16 MDA Data Standards Repository provides CDEs Reporting Store Data Stores ADT, Lab….. Replication or ETL Data from Transactional Systems to RR / Reporting / Data Warehouse Environments Federated Research Data Repositories w/ all historical data and real-time and near-time data feed Support Analytics across clinical research and translational research Dashboard Applications Report to external entities FDA (HL7 v3 RIM message), CDUS, NCI, Pharma, etc. Logical model beneath each application conform or map to MDA Enterprise Information Model MDA Data Integration Strategy National Domain Analysis Models: BRIDG, HL7 v3 RIM National Data and Vocabulary Standards: caDSR, EVS, SNOMED, CDISC, etc. Align and Map Vocabulary Service Group SOA Governance Data Modeling Service and stores Gateway stores and transactional stores MDA DSR Application Specific Data Stores. SOASOA SOASOA

17. 17 Federated Metadata Management “borrowed” from OSU presentation!

18. 18 Design Proof of concept trial Two-phase pilot project to demonstrate the usability, practicality and value of having an enterprise semantic infrastructure to support clinical, research and administrative applications. We are implementing the U.K. CancerGrid metadata registry solution (cgMDR) as an enterprise data standards infrastructure. This strategy enables us to support the commercial clinical trials management system (CTMS), and align with caBIG® standards. Phase 1 includes deployment of this infrastructure with point-to- point web services Phase 2 involves deployment of these services on a functional service bus (caXchange).

19. 19 Goals To develop best practices with regard to business processes and governance of this workflow Optimize end-user training, acceptance and utilization of the metadata infrastructure Lifecycle management of semantic artifacts within the enterprise Security and auditing requirements for the framework, Development of core requirements for connectivity and synchronization to the NCI caBIG® standards and the caDSR

20. 20 Pilot Use-Cases to support Search and retrieval of common data elements (CDEs) created to support the caBIG® CTMS sponsored applications from the caDSR with loading into the cgMDR Search for and comparison for enterprise standard data elements needed for a protocol development Curation of new enterprise CDEs using the cgMDR toolset, to facilitate tracking and discovery Curation of Domain –specific non-enterprise data elements for domain specific protocols Search and comparison of non-enterprise standard domain specific data elements for potential re-use and promotion to Standards Selection of CDEs to use in our CTMS application cgMDR export and CTMS import of CDEs for form development

21. 21 Technologies (to be) used: U.K. CancerGrid UK - cgMDR caBIG® caDSR/ iso 11179 standard for Data Elements caXchange Excel – maybe Enterprise Architect - maybe

22. 22 Metadata Flow

23. 23 Phase 1 Conceptual Architecture

24. 24 cgMDR Phase 1 – Physical Architecture - Web Services High Level Structures

25. 25 Phase 2 Conceptual Architecture

26. 26 cgMDR Phase 2 – Physical Architecture - Web Services High Level Structures

27. 27 MDR Challenges Terminology binding in Excel CDE create tool Loading terminologies in the user interface – not possible Closely bound to Exist database - can’t unplug Loading external ontologies in the user interface XPath based application – skills needed Data reporting tool limitations – mine metadata