1. BRIDG UpdateProtocol Representation Update HL7 Working Group Meeting Orlando, Florida 14 January 2009

2. BRIDG Update • 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

3. What’s In Release 2.1?

4. BRIDG THC 4

5. BRIDG Board of Directors

6. How to Work with the BRIDG THC • 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. Disease-specific Semantics • 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. Contact Information • www.bridgmodel.org • bridgTHC-L@list.nih.gov • BRIDG_USERS@list.nih.gov

9. Protocol Representation Update

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