1. BRIDG Update May HL7 Working Group Meeting 5 May 2008 1

2. BRIDG Update BRIDG Board of Director News BRIDG Technical Harmonization Committee News BRIDG Release 2.0 Status 2

3. What is BRIDG? Biomedical Research Integrated Domain Group A formal model A communication bridge An open community of stakeholders The semantic foundation for application and message development

4. BRIDG Scope Protocol-driven research and its associated regulatory artifacts, i.e. the data, organization, resources, rules, and processes involved in the formal assessment of the utility, impact, or other pharmacological, physiological, or psychological effects of a drug, procedure, process, or device on a human, animal, or other biologic subject or substance plus all associated regulatory artifacts required for or derived from this effort.

5. BRIDG Board of Director News New Name: BRIDG Board of Directors Dr. Christopher Chute elected as Chair – 1 year term New charter developed which includes by- laws and operating procedures – 2 types of members: Each founding stakeholder appoints 1 member Remaining 3-7 at large members elected to 3 year staggered term – Will elect one at large member this year 5

6. BRIDG Board of Directors 6 Appointed Members Charlie MeadNCI Armando OlivaFDA Dave Iberson-HurstCDISC Chuck JaffeHL7 At Large MembersTerm (Yrs) Christopher Chute2 Becky Kush3 John Speakman2 Christo Andonyadis1

7. 7 BRIDG THC NameAffiliation Charlie MeadNCI / Booz Allen Hamilton Steve SandbergNCI / Mayo Smita HastakNCI / Scenpro Wendy Ver HoefNCI / Scenpro Becky AngelesNCI / Scenpro Julie EvansCDISC Saurin MehtaCDISC / Novartis Jay LevineFDA

8. Release 2.0 Plan – 1 Release 2.0 scheduled for April 2008 – Update: Changed to May 2008 R2.0 new content: AE, C3PR (NCI’s Patient Registry) Full binding of all static attributes to HL7 V3 data types – – Clarification: Will bind to HL7 V3 R2. Candidate terminology lists/value sets (drawn from existing standards if possible) for all attributes bound to ‘coded concept descriptor’ data types – Update: Develop f ull description of meta-data/data/ value-set binding to outline THC responsibilities going forward 8

9. Release 2.0 Plan - 2 Consolidation of ‘business process pillars’ in the model with guideline of > creating the RIM problem of ‘duplicitous attributes.’ Introduction of formal business rules as class invariants using both free text and equivalent parsable OCL statements Representation of ‘player/scoper’ semantics Complete mapping of BRIDG Model static attributes to the HL7 RIM Test evaluation of strategy for incorporating BRIDG Model ‘sub- domains’ (e.g. cancer-specific semantics, TB semantics) using NCI’s CTOM 9

10. Release 2.0 Plan – 3 Creation of more exemplary instance diagrams (e.g. AE content, SDTM IG, etc.) New: Resolve several naming and core representational issues around TDM, study calendar, etc Resolution of several model inconsistencies (e.g. Observation – ObservationResult vs Assessment (no AssessmentResult) Infrastructure improvements including CVS, FAQ, and revised mapping documents – Scoped for R2: FAQ + Mapping Document position. Infrastructure still in planning stage 10

11. R2 Policy Changes 1-2 releases per year, at the discretion of the THC Project mapping spreadsheets will be owned and maintained by project teams rather then the BRIDG THC. So, these spreadsheets will no longer be published with each release. BRIDG THC will publish the first mapping from BRIDG to RIM. 11

12. 12 What’s In Release 2.0? ProjectStakeholder Study Data Tabulation Model (SDTM)CDISC Regulated Product Submission (RPS)FDA/HL7 RCRIM Patient Study Calendar (PSC)NCI Trial Design Model (TDM)CDISC caXchange/LabHubNCI/HL7 RCRIM TC/CDISC Clinical Trial Object Model (CTOM)NCI Adverse EventsCDISC, NCI, FDA, Federal AE Task Force Cancer Central Clinical Patient Registry (C3PR) NCI Person / Organization (Player / Scoper)NCI

13. 13 What’s Coming After Release 2.0? ProjectHarmonization DateStakeholder Clinical Trial RegistryJune 2008CDISC / HL7 Protocol Abstraction – goes with CTRJune 2008NCI Protocol RepresentationCDISC / HL7 Structured Product LabelFDA CardiologyDuke Clinical Research TuberculosisDuke Clinical Research Statistical Analysis, including SAPLate 2008 / early 2009CDISC RPS Release 2End of 2008?FDA CDISC HL7 Message Project GapsLate 2008 / Early 2009?FDA PharmacogenomicsFDA/CDISC/HL7 Eligibility Criteria (EMR perspective)W3C Clinical Observation Interoperability

14. Questions and Answers 14