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The Study Data Tabulation Model developed by the Clinical Data Interchange Standards Consortium (CDISC) is a standard adopted by FDA as a mechanism for exchanging study data.
FDA, in close collaboration with CDISC, is engaged in a project to develop XML messages for CDISC content that is based on the HL7 RIM (Reference Information Model). The project scope is to create four HL7 V3 messages from existing content within the CDISC standard that can ultimately be balloted in HL7. The CDISC content will be mapped to four messages as follows:
Proposed Message |
CDISC Content |
---|---|
Study Design |
a) Study Summary (Clinical Trial Registry) |
Study Participation |
e) collected data/study data tabulations |
Subject Data |
e) collected data/study data tabulations |
ICSR (existing HL7 V3 message may need to be extended |
e) collected data/study data tabulations |
The project involves using the BRIDG (Biomedical Research Integrated Domain Group) domain analysis model. This model is used by both CDISC and the HL7 RCRIM TC (Regulated Clinical Research Information Management Technical Committee). CDISC is in charge of the content and business requirements and harmonization of the components of the CDISC standard into the BRIDG model. FDA is responsible for modeling and message development. These two streams will work in parallel with close collaboration and interaction.
We also plan on using CMETs (Common Message Element Types) and other HL7 or non-HL7 artifacts for this work. This project is closely aligned with the HL7 Individual Case Safety Report (ICSR) message.
We welcome all those interested to participate in this project. For more information, please contact:
CDISC Stream: (requirements gathering, BRIDG harmonization): Dave Iberson-Hurst or Jay Levine.
FDA Stream: (HL7 V.3 modeling and message development): Jason Rock.
CDISC HL7 Project – Presentation to HL7 RCRIM TC, 9/17/2007
CDISC HL7 Project Document – Shared with the HL7 RCRIM TC, October 2007