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HL7 Working Group Meeting 12 September 2006

BRIDG Update. HL7 Working Group Meeting 12 September 2006. BRIDG Activities Since Last WGM. Broadened BRIDG scope to include all RCRIM activities Posted BRIDG “veneer” at www.bridgproject.org

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HL7 Working Group Meeting 12 September 2006

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  1. BRIDG Update HL7 Working Group Meeting 12 September 2006

  2. BRIDG Activities Since Last WGM • Broadened BRIDG scope to include all RCRIM activities • Posted BRIDG “veneer” at www.bridgproject.org • Held a three day AE harmonization modeling session (reps from ICSR, caAERS, SDTM, FAET) – agreement to have this session made at January WGM • Held one Technical Harmonization meeting for planning • BRIDG Education planning started • Started Statistical Analysis Plan project modeling • Continued Trial Design project modeling

  3. BRIDG Mission – from RCRIM May WGM Minutes The diagram recognizes that Stability data is not driven from clinical research protocols, RPS and SPL extend to class II device products and other products that are not protocol driven and both safety messages extend beyond the BRIDG space as currently defined. Either BRIDG needs to be expanded in scope to accommodate all RCRIM messages or RCRIM needs more than on DAM. No conclusion was reached. The team did agree that we should develop harmonization artifacts from each of the messages that already have been developed.

  4. BRIDG Mission • Protocol-driven research (human / animal / device) and associated regulatory frameworks (processes / procedures / artifacts). • This mission supports all RCRIM projects.

  5. BRIDG Advisory Board Discussion Topics

  6. BRIDG Advisory Board • The mission of the BRIDG Advisory Board is to ensure that the furtherdevelopment, maintenance and governance of the model continue in acollaborative, open and coordinated manner. The Board will also manage the scope of the model and ensure that it is maintained. • BRIDG Stakeholders: HL7, FDA, NCI, CDISC • Members: • Doug Fridsma – co-leader (NCI / U of Pittsburgh) • Julie Evans – co-leader (CDISC) • Becky Kush (CDISC) • Wayne Kubick (CDISC / Lincoln Technologies) • Landen Bain (CDISC / HL7) • Randy Levin (FDA) • Christo Andonyadis (NCI) • Charlie Mead (HL7 / NCI) • Alex Ruggieri (Amgen) • Chris Chute (HL7)

  7. BRIDG Advisory Board Discussion Topics • Do we have the right representation on the BRIDG Advisory Board?

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