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CDISC Content to Message HL7 Development Overview

CDISC Content to Message HL7 Development Overview. Jason Rock 856.854.4455 Jason.Rock@GlobalSubmit.com. Goal. Create one message model for standard clinical study data Use one model for human and animal data Integrate with other standards: SPL, ICSR, RPS

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CDISC Content to Message HL7 Development Overview

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  1. CDISC Content to MessageHL7 Development Overview Jason Rock856.854.4455Jason.Rock@GlobalSubmit.com

  2. Goal • Create one message model for standard clinical study data • Use one model for human and animal data • Integrate with other standards: SPL, ICSR, RPS • Allow FDA to store clinical data in the Janus database • CDISC HL7 project is part of FDA strategic initiatives to improve public health and patient safety

  3. Out of Scope • Content changes • Documentation submitted today is the same documentation submitted tomorrow • Exception: Relationship between observations is more prescriptive • Business process changes • Learn from each other and enhance future processes to suit our needs

  4. Use • Animal and Human products • Initial use case are US

  5. Why not SDTM? • The existing transport format (SASXPT V5) has 8 character field limits, among other limitations. • SDTM allows for too much variability across companies • SDTM does not inherently capture all of the relationships between study data, or the relationships between the design of a study and the study data as desired by FDA. • Difficult and error prone to load in to a database

  6. Why HL7? • Exchange format of choice for health care information • ANSI accredited, open, consensus based Standards Development Organization • Integration with health care related exchange standards and mandates • Integration with other FDA HL7 standards • HL7 is the preferred electronic exchange format for healthcare information, per the Department of Health and Human Services.

  7. Development Team • Jason Rock (GlobalSubmit): Facilitator (Chair) • Erik Henrikson (FDA): Project Manager • Peggy Leizear (FDA): HL7 Publishing • Bron Kisler (CDISC): Vocabulary • Jay Levine (FDA): Domain Expert

  8. Work plan • Based on HL7 Reference Information Model • Leverages existing HL7 standards (e.g., EHR, ICSR) • Contains CDISC content • Harmonized with the BRIDG • Initial requirements gathered from the BRIDG analysis project. • Additional requirements identified during development incorporated into the BRIDG

  9. FDA Use Cases • What is going to be done in the study? • Investigational application new Protocol submission • Who is involved in the conduct of the study? • Investigational application annual report • Marketing application study report • What was observed during the study? • Marketing application study report • Investigational application expedited adverse event reports • What expedited adverse reactions were reported? • Expedited adverse event reports

  10. Message in Use SPL CDISC HL7 Message HL7 ICSR for Adverse Events HL7 Data Checker and Loader JANUS ANALYTICAL DATA WAREHOUSE SDTM ADAM View 1 View 2 … View N

  11. DSTU Plan • Industry – Create submissions • NCI – loading in Janus • FDA • Loading in to Janus • Evaluate views from Janus • GlobalSubmit • Create web forms that create message • Create loader in to Janus • Create views from Janus

  12. Proposed Timeline* * Preferably, all messages developed concurrently

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