CDISC Content to MessageHL7 Development OverviewJason Rock856.854.4455Jason.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

• 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

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

Use

• Animal and Human products• Initial use case are US

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

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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.

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

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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

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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

SDTM ADAM View 1 View 2 … View N

JANUS ANALYTICAL DATA WAREHOUSE

HL7 Data Checker and Loader

SPL CDISC HL7 Message

HL7 ICSR for Adverse Events

Message in Use

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

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Phase, Major Deliverable, Activity or Milestone Date

Create Project Charter January, 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 documentation July 07 – Aug 08

Quality verification to go to DSTU ballot July 2008

Conduct DSTU ballot (work with Publishing Committee) August 2008

DSTU Ballot reconciliation September 2008

Quality verification to go to Normative ballot March 2008

Conduct Normative ballot (work with Publishing Committee) April 2009

Normative Ballot reconciliation May 2009

Proposed Timeline*

* Preferably, all messages developed concurrently