1. HL7 Working Group Meeting Orlando, Florida 14 January 2009 1

2. BRIDG 2.1 released October 2008 New semantics in 2.1 are Clinical Trial Registry, Protocol Abstraction, minimal Eligibility Criteria (draft) Current work for next release (R2.2): include semantics of HL7 CDISC Study Design and Study Participation messages in BRIDG Study Design – R2.2 Study Participation – R2.2 ICSR - R2.x Subject Data - R2.x Common Product Model – out of scope for BRIDG Release 3 schedule will be determined by start of Q2 of 2009 New THC Member – Marti Velezis New Board Member – Jack Jones 2

3. 3 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 Clinical Trial RegistryCDISC Protocol AbstractionNCI Eligibility Criteria (draft)NCI, CDISC

4. 4 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 Marti VelezisCDISC / ii4SM

5. 5 Appointed Members Charlie MeadNCI Armando OlivaFDA Dave Iberson-HurstCDISC Chuck JaffeHL7 At Large MembersTerm (Yrs) Christopher Chute2 Becky Kush3 John Speakman2 Jack Jones3

6. 6 For projects that want to harmonize semantics with BRIDG: Project team should contact THC via website listserv for BRIDG THC at (get listserv name from Smita) The THC will assign a point of contact for the project. The THC point of contact will answer BRIDG questions, consult with team about progress, schedule BRIDG harmonization, bring project issues to the THC, etc. Project team representatives will attend the harmonization meeting with the THC For general questions about BRIDG Post to the BRIDG listserv THC members are responsible for communicating important BRIDG info to the stakeholders

7. 7 Currently, BRIDG does not include disease-specific semantics Current proposed strategy (with no definitive answer yet) Disease specific content will be subclasses of BRIDG classes. Disease specific models will be managed by the disease domain experts. We need to consider the line between information models and terminology models We need R3.0 (2 layer model) to actively address strategy. The lower layer of R3.0 will be the RCRIM DMIM -> mapping to RMIMs will be possible, e.g., Clinical Statement RMIM

8. 8 www.bridgmodel.org bridgTHC-L@list.nih.gov BRIDG_USERS@list.nih.gov

9. 9

10. Protocol Representation V1.0 in BRIDG 2.1 Documentation in progress PRG review Feb, 2009 Final due Mar 31, 2009 Post for 30 day comment period Review, respond and revise per comments Update Protocol Representation in BRIDG 3.0 BRIDG 3.0 JIC ballot – expected Q3/Q4 2009 balloted Protocol Representation model

11. 11 Clinical Trial Tracking, Study Summary (SDTM) Clinical Trial Registry CDISC Trial Design Part I (arms, elements, visits) CDISC Trial Design Part II Planned assessments & interventions (NCI Study Calendar) Eligibility Criteria (most common) CDISC Statistical Analysis Plan Other Protocol Template Sections and Attachments Protocol Representation Excel Spreadsheet BRIDG Mapping; Harmonization PR V 1.0 Standard Documentation XML Schema Development (ODM Extension) PR V 1.x (2009) PR V 1.0 2008 CDISC-HL7 Protocol Representation Standard - Development