1. CDISC-HL7 Project Update Armando Oliva, M.D. FDA Sponsor HL7 Workgroup Meeting January 14, 2008 San Antonio TX

2. Outline FDA Drivers … Why CDISC-HL7? Project Update –Dave Iberson-Hurst (Stage 1B) –Jason Rock (Stage II) Discussion

3. Why CDISC-HL7? 1.Improved Data Management –Move away from SAS Transport –More Robust Data Model for Clinical Observations –Better able to relate clinical observations with each other and with planned observations –Improved data loading into Janus Data Warehouse 2.Harmonize with other HL7 standards for regulated medical product information –Single data model for all clinical observations related to medical product throughout the product life-cycle – improved safety assessments 3.Better integration with EHRs as they start being used for both Clinical Research and Surveillance –Facilitate and eventually lower costs of data flow/management from collection to submission

4. CDISC-HL7 Project Stages Stage 1A – Exploratory Project –Now concluded (11/27/2007 RCRIM vote to move to 1B / II) –Conclusion: Develop 4 messages: study design, study participation, subject data, HL7 ICSR (modification if necessary) Stage 1B –Requirements Gathering, Gap Analysis, BRIDG Harmonization Stage II – Modeling and Message Development Stage 1B and II proceeding concurrently –Why? Most of SDTM already in BRIDG, which can inform Stage II now

5. CDISC-HL7 Project-- Information Flow RCRIM TC / Orders and Observation TC, Patient Safety SIG, other HL7 and non-HL7 groups CDISC – HL7 Project Team CDISC Sub-Team (Stage I-B) Requirements Gathering GAP Analysis BRIDG Harmonization Storyboards CDISC Content Facilitators: Dave Iberson-Hurst (CDISC) Jay Levine (FDA) HL7 Development (Stage II) Modeling Message Development HL7 Facilitator: Jason Rock (Global Submit) Facilitator: Erik Henrikson, FDA

6. Stage 1B Update – Dave Iberson-Hurst Stage II Update – Jason Rock

7. Participants Jay Levine Dave Iberson-Hurst Mead Walker Jason Rock Cara Willoughby Diane Wold John Speakman Julie Evans Armando Oliva Rebecca Kush Edward Helton Lise Stevens

8. Method of Working Document –Drivers / Business Case –Requirements –Use Cases –Gaps TCs once a week –Started 13 th December 2007 Open call every 4 th Week

9. Document Status Drivers / Business Case –First draft text –Needs refining Requirements –Basic Framework developed –Now putting meat on to the bones Use Cases Gaps

10. BRIDG Use the document to feed BRIDG Take the information in the document as the basis of updating BRIDG BRIDG serves as the requirements for Stage 2

11. Discussion