1. CDISC Content to Message HL7 Development Overview Jason Rock 856.854.4455 Jason.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. 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. 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. 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. SDTMADAMView 1View 2…View N JANUS ANALYTICAL DATA WAREHOUSE HL7 Data Checker and Loader SPL CDISC HL7 Message HL7 ICSR for Adverse Events Message in Use

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. 12 Phase, Major Deliverable, Activity or MilestoneDate Create Project CharterJanuary, 2008 Create storyboards (iterative process)Jan 08 – May 08 Create CIM from BRIDG / HL7 artifacts (iterative process)Feb 08 – June 08 BRIDG harmonization (iterative process)June 08 – July 08 Prepare ballot documentationJuly 07 – Aug 08 Quality verification to go to DSTU ballotJuly 2008 Conduct DSTU ballot (work with Publishing Committee)August 2008 DSTU Ballot reconciliationSeptember 2008 Quality verification to go to Normative ballotMarch 2008 Conduct Normative ballot (work with Publishing Committee)April 2009 Normative Ballot reconciliationMay 2009 Proposed Timeline* * Preferably, all messages developed concurrently