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BRIDG Update Protocol Representation Update

BRIDG Update Protocol Representation Update. HL7 Working Group Meeting Orlando, Florida 14 January 2009. BRIDG Update. BRIDG 2.1 released October 2008 New semantics in 2.1 are Clinical Trial Registry, Protocol Abstraction, minimal Eligibility Criteria (draft)

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BRIDG Update Protocol Representation Update

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  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

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