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

2. HL7 ICSR DSTU Update Progress to Date: PSSIG Harmonization Efforts
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 Women’s 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:
MedWatchPlus, 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” 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)

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 VICH GL42
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