HL7 ICSR DSTU UPDATE

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
• 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
• 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
• Lise.Stevens_at_fda.hhs.gov
• Mead Walker Modeling Faciliator
• dmead_at_comcast.net
• Jason Rock ICSR Generation and Transform Tool
• jasonrock_at_globalsubmit.com