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HL7 ICSR DSTU UPDATE. Patient Safety SIG RCRIM Joint Meeting HL7 January Working Group Meeting. HL7 ICSR DSTU Update. Progress to Date: Identification of testing stakeholders FDA Harmonization Vocabulary Domains Schema Generation Tool: XFORM PSSIG Harmonization Efforts

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hl7 icsr dstu update

HL7 ICSR DSTU UPDATE

Patient Safety SIG

RCRIM Joint Meeting

HL7 January Working Group Meeting

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HL7 ICSR DSTU Update
  • Progress to Date:
    • Identification of testing stakeholders
    • FDA Harmonization
    • Vocabulary Domains
    • Schema Generation Tool: XFORM
  • PSSIG Harmonization Efforts
    • ISO/CEN/HL7/JIC ICSR
    • GHTF
    • VICH
  • Next Steps
hl7 dstu icsr update
HL7 DSTU ICSR Update
  • Identification of Stakeholders
    • US Govt: VA & NIH
    • Regulators:
      • Australian Competent Authority
      • VICH GL 42
      • Japan
    • Healthcare Providers:
      • Mirixa Corp. (Pharmacy services provider)
      • ASTER Project: Pfizer & Brigham and Women’s Hospital
    • Vendors
      • Quantros
      • GlobalSubmit
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HL7 ICSR DSTU Update
  • Developed high-level templates to collect information about what will be tested:
    • Interactions and storyboards
    • End user tooling
    • Vocabulary requirements
  • Held teleconferences in Oct and Nov
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HL7 ICSR DSTU Update
  • FDA Harmonization:
    • MedWatchPlus, FAERS, Pre-market AEs
    • Mapping across all data collection forms
    • Mapping to existing e-submission formats

Which resulted in:

  • Identification of Vocabulary Domains
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HL7 ICSR DSTU Update
  • Vocabulary Domains:
    • Performed a high-level review of what is currently available as FDA or outside reference sources: HL7, NCI, UMLS, others
    • Streamlined the work to a even higher-level to help prioritize the work with NCI
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HL7 ICSR DSTU Update
  • Schema Generation Tool:
    • FDA XFORM
    • New HL7 Schema Generation tool now available
  • Developed and hosted by GlobalSubmit:
    • Current prototype: 3500 and 3500A
    • “crude” 1st step for schema generation and validation to help implementers
    • Generates HL7 XML and transforms to E2B(M)
    • Next generation will cover coding and other product areas (animal reporting, eMDR)
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HL7 ICSR DSTU Update
  • PSSIG Outreach and Harmonization Efforts:
    • ISO/CEN/HL7: Pharmacovigilence (ICSR)
    • VICH GL 42
    • GHTF N87
    • BRIDG AE Harmonization
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HL7 ICSR DSTU Update
  • ISO/CEN/HL7 JIC ICSR
    • Completed initial mapping, identified gaps and the need to clarify how ICH content is represented in “hidden” attributes
      • EX: Use of code/value pairs for investigative subjects, concurrent observations, reporting criteria
  • VICH GL42
    • VICH parties signed agreement to test HL7 ICSR, most likely Release 3
    • Provided DSTU instance examples for Release 2, FDA harmonization of vet terms
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HL7 ICSR DSTU Update
  • GHTF N87
    • Presented HL7 ICSR to GHTF Oct ’07
    • Mapped N87 to HL7 ICSR
    • Discussing “extensions” used in other countries: UK & Germany
    • Meeting planned with UK Q1-Q2 ’08
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HL7 ICSR DSTU Update
  • BRIDG AE Harmonization
    • Active participation by identified stakeholders since June ’07 through weekly telecons!
    • Programs/projects mapped
      • ICSR
      • FAET
      • caAERS
      • SDTM
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HL7 ICSR DSTU Update
  • Finalize agreement on AE model at end of HL7 meeting to present at Feb BRIDG harmonization
hl7 icsr update
HL7 ICSR Update
  • Next steps:
    • Follow up with all stakeholders to review testing schedule: Establish a formal workgroup: Propose an HL7 workgroup
    • Continue XFORM development and posting of material on FDA and PSSIG website
  • Prioritize immediate vocabulary for DSTU testing, conformance and implementation guides:
    • HL7 ICSR R1 domains
    • HL7 ICSR R2 domains & value sets
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HL7 ICSR Update

Next steps continued:

  • Finalize attributes for MedWATCH Plus Rational Questionnaire
    • Mandatory, required, optional
  • Submit an HL7 Project Scope Document for ICSR Release 3: Timeline for final membership ballot by October 2009
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HL7 ICSR DSTU Update

DSTU Testing Coordination:

  • Lise Stevens: PSSIG Project Chair
    • Lise.Stevens@fda.hhs.gov
  • Mead Walker: Modeling Faciliator
    • dmead@comcast.net
  • Jason Rock: ICSR Generation and Transform Tool
    • jasonrock@globalsubmit.com