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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

CDISC-HL7 Project Update

Armando Oliva, M.D.

FDA Sponsor

HL7 Workgroup Meeting

January 14, 2008

San Antonio TX

  • FDA Drivers … Why CDISC-HL7?
  • Project Update
    • Dave Iberson-Hurst (Stage 1B)
    • Jason Rock (Stage II)
  • Discussion
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
cdisc hl7 project stages
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
cdisc hl7 project information flow
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


CDISC Content Facilitators:

Dave Iberson-Hurst (CDISC)

Jay Levine (FDA)

HL7 Development (Stage II)


Message Development

HL7 Facilitator:

Jason Rock (Global Submit)

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

method of working
Method of Working
  • Document
    • Drivers / Business Case
    • Requirements
    • Use Cases
    • Gaps
  • TCs once a week
    • Started 13th December 2007
  • Open call every 4th Week
document status
Document Status
  • Drivers / Business Case
    • First draft text
    • Needs refining
  • Requirements
    • Basic Framework developed
    • Now putting meat on to the bones
  • Use Cases
  • Gaps

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