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Study Data Standards Resources

      • Study Data Specifications
      • CDISC Study Data Tabulation Model (SDTM) Standard: 
        • SDTM, developed by the Clinical Data Interchange Standards Consortium (CDISC), is a study data standard adopted by FDA as a mechanism for the analysis of study data. The Study Data Tabulation Model can be obtained from the Clinical Data Interchanges Standards Consortium (CDISC) web site at: http://www.cdisc.org/models/sds/v3.1/index.html
        • Implementation Guides:  The Study Data Tabulation Model Implementation Guide (SDTM-IG) for clinical study data can be obtained from the CDISC web site at: http://www.cdisc.org/models/sds/v3.1/index.html
    • CDISC (SEND) Standard:  
      • SEND, developed by the Clinical Data Interchange Standards Consortium (CDISC), is an implementation of the Study Data Tabulation Model for data collected from animal toxicology studies.
      • Implementation Guides:  The Standard for Exchange of Nonclinical Data Implementation Guide (SEND-IG) for Animal Toxicology Studies can be obtained from the CDISC web site at: http://www.cdisc.org/standards/index.html. 
    • CDISC/HL7 Messages: 
      • FDA, in close collaboration with CDISC, engaged in a project to develop HL7v3  messages for CDISC content that are based on the HL7 RIM (Reference Information Model).   FDA intends to begin accepting study data in HL7v3 format in 2013.  The proposed messages and CDSIC content are summarized in the following table:

 

Proposed Message

CDISC Content
Study Design a) Study Summary (Clinical Trial Registry)
b) Eligibility Criteria
c) Trial Design
d) Statistical Analysis Plan
Study Participation e) collected data/study data tabulations
Subject Data (extension of Patient Care Record) e) collected data/study data tabulations
f) derived data/analysis datasets
ICSR (existing HL7 V3 message may need to be extended
to accommodate AE reporting for clinical trials)

e) collected data/study data tabulations

 

 

We welcome all those interested to participate in this project. For more information, please contact:

 

CDISC Stream: (requirements gathering): Dave Iberson-Hurst or Jay Levine.

 

FDA Stream: (HL7 V.3 modeling and message development): Jason Rock.

 

Resources:

 

CDISC HL7 Project – Presentation to HL7 RCRIM TC, 9/17/2007

 

CDISC HL7 Project Document – Shared with the HL7 RCRIM TC, October 2007

 

Janus Operational Pilot

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