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 “alpha-version”

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 gapsCharacterized vocabulary requirements by level of

complexity: low, medium, highLow: race/ethnicity, sex/gender, case seriousnessMedium: 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 AERSViSTA EMR auto-generation of ICSR

Pfizer/Brigham and Women’s Hospital:Phase I: ODM-to-E2B transform & validationPhase 2: ODM-to-HL7 ICSR transformBrigham 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 largePosted to PSSIG site instead of HL7 DSTU siteCreated PSSIG page on wiki, but needs more workNeed to define “rules of engagement” for posting test

materials, changes, progress notesCoordinating 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