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CDISC-HL7 Project Update

CDISC-HL7 Project Update. Armando Oliva, M.D. FDA Sponsor HL7 Workgroup Meeting January 14, 2008 San Antonio TX. Outline. FDA Drivers … Why CDISC-HL7? Project Update Dave Iberson-Hurst (Stage 1B) Jason Rock (Stage II) Discussion. Why CDISC-HL7?. Improved Data Management

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CDISC-HL7 Project Update

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  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? • 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 • 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 • 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 Facilitator: Erik Henrikson, FDA 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)

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

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

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

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