NCICB Jamboree February 25, 2005

1. NCICB Clinical Trials Infrastructure NCICB Jamboree February 25, 2005

2. Clinical Trials Infrastructure

3. Infrastructure Components • Clinical Systems – Systems providing clinical data management in all aspects of the clinical trials life-cycle • HL7 SDK - Toolkit which facilitates the building, parsing, and validation of HL7 v3 messages • Message Exchange – Service supporting HL7 v3 message transmission and routing • HL7 Transactional Database - HL7 v3 transactional database with clinical data access services • De-identification Service – Service for de-identifying patient information from HL7 v3 messages • Cancer Data Standards Repository (caDSR) - Shared metadata repository defining clinical Common Data Elements (CDEs) • Enterprise Terminology Services (EVS) - Terminology service for hosting HL7 v3 registered terminology • Clinical Applications and Decision Support Systems – Applications that leverage integrated clinical and research data to aid in the discovery of novel therapies that will ultimately result in a better prognoses for cancer

4. Clinical Systems • The NCICB provides technologies supporting all aspects of the clinical trials life-cycle • The NCICB’s Cancer Centralized Clinical Database System (C3DS) provides the research community with the infrastructure to collect and manage clinical trials data • The NCICB established cancer Biomedical Informatics Grid (caBIG) program aims at developing clinical systems including: • Adverse Events Reporting • CTMS/CDUS Reporting • Laboratory Interfaces • Protocol Authoring • Financial Billing • The HL7 v3 messaging framework provides a standards based infrastructure that enables integration between clinical systems • The HL7 v3 message framework facilitates both syntactic and semantic interoperability

5. What is HL7? • Heath Level Seven (HL7) is a not-for-profit ANSI- accredited Standards Developing Organization (SDO) operating in the healthcare arena • HL7 Provides standards for data exchange to allow interoperability between healthcare information systems • HL7 focuses on the clinical and administrative data domain • HL7 messaging (v2.x and higher) has been recommended as data exchange standard by the E-Govt initiative • HL7 v3 messages follow object-oriented developmental methodology based on a UML model and provides XML based message exchange • The fundamental model from which all v3 messages are derived is referred to as the Reference Information Model (RIM)

6. HL7 v3 RIM Four Base Objects: Entity, Role, Participant, Act

7. HL7 v3 Artifacts R-MIM RIM D-MIM 1..* 1..* HMD 1..* MT <xml> 1..*

8. HL7 Software Development ToolKit (SDK) • Facilitates the building, parsing, and validation of HL7 v3 messages • Leverages the HL7 Java SIG SDK software • HL7 SDK components include: • HL7 V3 XML Builder – Building HL7 v3 messages from object graph • HL7 V3 XML Parser – Extracting information from HL7 v3 messages • Metadata Loader – Implementation of HMD meta loader • HL7 V3 Artifacts – Implementation of RIM objects and data types • Validation Services - HL7 v3 structural vocabulary and W3C XML schema validation service. Leverages the NCICB common data elements and terminology infrastructure and the HL7 v3 Common Terminology Services (CTS) interface • Mapping Utility – Utility for mapping clinical data to the HL7 v3 message specification

9. HL7 SDK Architecture HMD HL7 SDK Clinical Meta Data JavaSIG Software Clinical Application Database HMD Meta Loader Validation Schema XSD XML Parser Mapping Framework Vocabulary XML Builder EVS CSV Flat File RIM; Data type and Meta Data Objects Core Engine (RIM Object Generator) HL7 v3 xml file

10. HL7 SDK Message Building/Parsing • Parse XML to Object Graph • Validate graph against EVS 3. Build XML from Object Graph 4. Validate outputted XML against schema XML EVS RIM HMD

11. Mapping Utility • Analyst maps HL7 v3 message specification to the clinical system CDEs and creates a master spreadsheet • Developer exports a flat file in the order specified by SDK object graph for the HL7 v3 message

12. Mapping Utility (cont.) 3. The HL7 SDK generates a mapping file according to the master spreadsheet 4. Developer loads the RIM Object Graph with data from the flat file For this clone, fetch data from column FILE : OC_COCT_MT090102.csv

13. Generated HL7 v3 Message 5. HL7 SDK uses the object graph and builds the HL7 v3 message instance

14. HL7 Transactional Database • The HL7 transactional database provides a standards based repository to persist and retrieve HL7 v3 messages • Currently piloting Oracle’s HTB (Health Care Transaction Base) as an “off-the-shelf” solution for HL7 message persistence and retrieval • HTB is a data repository and service infrastructure that provides a unified data model based on the HL7 v3 RIM • HTB supports industry standards, such as HL7, HIPAA privacy regulations, and standard terminology sets including SNOMED, CPT4, and ICD9 • The pilot effort is focused on the use of the HTB functions for clinical messaging needs, development of proof-of-concept applications, and the alignment of terminology services • Pilot effort includes the persistence, retrieval, and transmission of HL7 v3 Laboratory Observation and Specimen messages via the Oracle HTB infrastructure • Includes exploration of Oracle HTB’s security policies/procedures • Demonstrates the accessibility of HL7 v3 data via a web-based query example that leverages the Oracle HTB API

15. Oracle HTB Infrastructure iHUB Web Browser HL7 Lab Observation csv File HL7 v2.4 Lab Observation File GDI Xtender GDI Xtender Query Example HL7 v3 Lab Observation HTB HL7 v3 Lab Observation Document HTB API HTB IMP MLLP Outbound Enterprise Object Model HTB OMP HL7 Data Base

16. Query Prototype- Labviewer

17. HL7 Message Exchange • The HL7 message exchange service provides a mechanism for exchanging data with multiple, geographically dispersed systems in the cancer research community • The Oracle Integration Hub (iHub) product was leveraged as a message exchange vehicle during the Oracle HTB pilot effort • The proposed HL7 message exchange service may leverage ebXML • ebXML (Electronic Business using eXtensible Markup Language) is a standard method for exchanging business messages developed by the Organization for the Advancement of Structured Information Standards (OASIS) • ebXML defines a message envelope and header for transferring messages over TCP/IP, HTTP, or SMTP and the behavior for applications processing ebXML messages • The ebXML payload can contain different message types (e.g. HL7, MAGEML, etc.) ebXML Structure Communications Protocol SOAP with MIME Envelope MIME SOAP Envelope MIME Payload

18. De-identification Service • The patient de-identification service provides a mechanism for de-identifying HL7 v3 messages • The patient de-identification service removes patient information from incoming clinical trials messages based on the Safe Harbor de-identification method • The patient de-identification goals and objectives include: • Meet HIPPA and other privacy rules and regulations • Protect patient privacy while providing access to de-identified data for research purposes • Provide an source solution for the caBIG community

19. Clinical Research Applications • Data will be de-identified, transformed, and persisted in a clinical research database • The clinical research database will provide a clinical research repository with open-source API access via NCICB’s cancer Biomedical Informatics Objects (caBIO) • caBIO clinical research services will be advertised to the grid to facilitate translational research across the caBIG community • CMAP and Rembrandt are example translational research portals that leverage clinical and genomics research data

20. Acknowledgements Smita Hastak Wendy Ver Hoef Dan Grandquist Sue Dubman Christo Andonyadis Steven Lui Charlie Mead Josh Temkin Jeffrey Polyak Sharon Settnek Eric Chen Matt Giordano Jayfus Doswell • For further information, see: • http://ncicb.nci.nih.gov • http://caBIG.nci.nih.gov • http://cmap.nci.nih.gov Bill Britton Vanessa Caldwell