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BRIDG Update

BRIDG Update. HL7 Working Group Meeting San Diego, California 13 September 2011 Tuesday Q2, 11-12:30. Agenda. BRIDG Overview Recent Accomplishments Current Activities Project Scope Statement Update Next Steps. BRIDG Overview.

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BRIDG Update

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  1. BRIDG Update HL7 Working Group Meeting San Diego, California 13 September 2011 Tuesday Q2, 11-12:30

  2. Agenda • BRIDG Overview • Recent Accomplishments • Current Activities • Project Scope Statement Update • Next Steps

  3. BRIDG Overview • BRIDG Purpose:A collaborative effort to produce a shared view of the dynamic and static semantics that collectively define a shared domain-of-interest. • Domain-of-interest/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, subject characteristic, biologic, cosmetic, food or device on a human, animal, or other subject or substance plus all associated regulatory artifacts required for or derived from this effort, including data specifically associated with post-marketing adverse event reporting. • Stakeholders: • Process:Board of Directors prioritizes projects and committee consults with projects and harmonizes project models into main model with help of project analysts/SMEs

  4. Recent Accomplishments • Harmonization of Hematopoietic Cell Transplantation (HCT) data elements (4 sets of 8) • Harmonization of NCI Case Report Form (CRF) Standard Rounds 1 & 2 • Harmonization of Nat’l Center for Research Resources’ Clinical and Translational Science Award (CTSA) Human Studies Database (HSDB) project – almost complete • Began discussions with OMOP project regarding harmonization • Development and posting of BRIDG Harmonization Package

  5. Current Efforts • Harmonization of MD Anderson/Nat’l Marrow Donor Program (NMDP) Hematopoietic Cell Transplantation (HCT) project - Remaining 4 of 8 sets • Will add bone marrow/stem cell transplant concepts to BRIDG • Genzyme’s RegistryNXT! • Will add rare disease registry concepts to BRIDG • Harmonization of NCI’s CRF Project – Remaining 2 of 4 rounds • Harmonization of CDISC Operational Data Model – Study Design Model (ODM-SDM) • Updated harmonization of FDA’s HL7 Study Participation message • Re-harmonization of HL7 Study Design Message • Internal efforts • Moving from gforge to Jira for project tracking • Updating BRIDG website • ISO Ballot Status • RCRIM ballot reconciliation • Next round of balloting in ISO JIC Ballot

  6. RCRIM Ballot Reconciliation • Ballot reconciliation spreadsheet sent to RCRIM on 8-Sept-2011. • Need to vote on accepting the package. • Julie to get confirmation from Gunther on negative major that was non-persuasive. • Vote will be scheduled for tc after confirmation.

  7. ISO Ballot Status • The ISO Central Secretariat sent comments to the BRIDG team regarding the BRIDG JIC ballot. The BRIDG team responded with proposals to address each comment. CDISC is now working with the new ISO TC 215 Technical Program Manager to confirm that our proposals will meet the ISO requirements. We expect to have an answer around the end of September. • Next round of ISO Balloting – need 6 months lead time – 1 month for ISO HQ to review/prepare ballot and 5 months for the Draft International Standard (DIS) ballot. • No set balloting schedule in ISO, but we try to align with a TC 215 Spring or Fall meeting so the ballot can be discussed in person. • The HL7 ballot needs to end at the same time as the ISO ballot. • Proposed ballot dates: • ISO ballot opens October 2011; closes by end of April 2012 • HL7 ballot opens April 2012 for May ballot

  8. BRIDG as a DAM Scope StmtBRIDG Harmonization Schedule

  9. BRIDG as a DAMHarmonization Process Document • BRIDG SCC has new Harmonization Package, including BRIDG Harmonization Process document • RCRIM has a BRIDG Harmonization Process and Procedures document, which has redundant information • Proposal: Update RCRIM document to refer to new BRIDG document, keeping RCRIM-specific content in the RCRIM document.

  10. Next Steps • Fall: • Harmonization of CDISC Statistics model • Continue harmonization of Hematopoietic Cell Transplantation (HCT) concepts • Continue harmonization of NCI CRF Standard • Call for BRIDG BoD nominations • Winter: • Publish next release of BRIDG in December • BRIDG BoD election

  11. What to do with these DAMs in RCRIM Ballot? • HL7 Study Design DAM • HL7 Study Participation DAM • We need to remove these DAMs from the ballot and point people to BRIDG since the DAMs are out of date and the updated semantics are in BRIDG: • How do we tell people where to look in BRIDG? It’s too big. We need project specific views of BRIDG. • Proposed Solution: Project teams create a project subset of BRIDG at the beginning of a project and also at each release. These project specific views will be part of the project ballot. • If BRIDG changes, we don’t change project view unless a new release of the project comes along. • Need to update RCRIM BRIDG harmonization document with these instructions • Motion to withdraw SD and SP DAMs from RCRIM ballot – motion carries

  12. Contact Information • BRIDG Project Home Page • www.bridgmodel.org • SCC Contact Listserv • bridgTHC-L@list.nih.gov • BRIDG Users Listserv • BRIDG_USERS@list.nih.gov • RCRIM: BRIDG as a DAM Listserv • bridg@lists.hl7.org

  13. Q & A

  14. Back up slides

  15. BRIDG Board of Directors 16 * Chair

  16. Semantic Coordination Committee 17

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