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HL7 ICSR DSTU UPDATE Patient Safety SIG RCRIM Joint Meeting HL7 January Working Group Meeting.

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Presentation on theme: "HL7 ICSR DSTU UPDATE Patient Safety SIG RCRIM Joint Meeting HL7 January Working Group Meeting."— Presentation transcript:

1 HL7 ICSR DSTU UPDATE Patient Safety SIG RCRIM Joint Meeting HL7 January Working Group Meeting

2 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

3 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 Womens Hospital –Vendors Quantros GlobalSubmit

4 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

5 HL7 ICSR DSTU Update FDA Harmonization: –MedWatch Plus, FAERS, Pre-market AEs –Mapping across all data collection forms –Mapping to existing e-submission formats Which resulted in: Identification of Vocabulary Domains

6 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

7 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 1 st 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)

8 HL7 ICSR DSTU Update PSSIG Outreach and Harmonization Efforts: –ISO/CEN/HL7: Pharmacovigilence (ICSR) –VICH GL 42 –GHTF N87 –BRIDG AE Harmonization

9 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

10 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

11 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

12 HL7 ICSR DSTU Update Finalize agreement on AE model at end of HL7 meeting to present at Feb BRIDG harmonization

13 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

14 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

15 HL7 ICSR DSTU Update DSTU Testing Coordination: –Lise Stevens: PSSIG Project Chair –Mead Walker: Modeling Faciliator –Jason Rock: ICSR Generation and Transform Tool

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