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 “alphaversion” XFORM
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
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
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
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
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
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