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HL7 ICSR DSTU Update

HL7 ICSR DSTU Update. FDA progress since last working group meeting: Completed mapping to all FDA AE programs, data collection forms and E2B Completed Phase I identification of vocabulary domain requirements Completed Phase I discussions with testing partners

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HL7 ICSR DSTU Update

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  1. HL7 ICSR DSTU Update • FDA progress since last working group meeting: • Completed mapping to all FDA AE programs, data collection forms and E2B • Completed Phase I identification of vocabulary domain requirements • Completed Phase I discussions with testing partners • Completed DSTU posting of ICSR content to PSSIG website • Completed Phase I development of an “alpha-version” XFORM

  2. HL7 ICSR DSTU Update • FDA AE data element mappings: • 3500, 3500A and E2B • Harmonization with CDISC HL7 project • Harmonization with proposed next release of SPL: device identification, serial and lot numbers & other improvements

  3. HL7 ICSR DSTU Update • Phase I vocabulary requirements: • Review of ICSR Release 1 vocabulary in NCI (devices only) & identified gaps • Characterized vocabulary requirements by level of complexity: low, medium, high • Low: race/ethnicity, sex/gender, case seriousness • Medium: Actions taken, codes for distinguishing report types: primary & secondary case notifications • High: Product identification and characteristics, observations: patient, lab, concurrent observations, ICSR investigation types: AE, product problems, product evaluations

  4. HL7 ICSR DSTU Update • Discussions with testing partners: • VA reporting from VA medical centers • 3500-E2B transform for auto-load into AERS • ViSTA EMR auto-generation of ICSR • Pfizer/Brigham and Women’s Hospital: • Phase I: ODM-to-E2B transform & validation • Phase 2: ODM-to-HL7 ICSR transform • Brigham EMR auto-generation of ICSR • Mirixa Corporation (Pharmacy Services) • 3500-E2B transform for auto-load into AERS

  5. HL7 ICSR DSTU Update • DSTU Posting to HL7 and wiki site: • Needs more work – current file is still too large • Posted to PSSIG site instead of HL7 DSTU site • Created PSSIG page on wiki, but needs more work • Need to define “rules of engagement” for posting test materials, changes, progress notes • Coordinating work with ICTC

  6. HL7 ICSR DSTU Update • XFORM Development: • Completed “alpha” version for release to testing partners: Formal posting date: Oct 8th • Phase I will save as an HL7 ICSR or E2B message • Primarily text based, and next release will focus more on coding data elements

  7. NEXT STEPS • Next Steps: • Begin building test files with partners • Continue vocabulary and data element finalization • Begin Phase 2 planning for testing with new FDA AE reporting portal • Begin alignment of device ICSR R1 with R2 testing • Begin discussions with other interested partners: VICH, GHTF, ISO TC 215

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