1. 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

2. 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

3. 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

4. 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 Womens 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

5. 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

6. HL7 ICSR DSTU Update XFORM Development: Completed alpha version for release to testing partners: Formal posting date: Oct 8 th Phase I will save as an HL7 ICSR or E2B message Primarily text based, and next release will focus more on coding data elements

7. 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