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CDISC Data Standards Resources

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.

SDTM Standard:

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

SDTM 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

The Standard for Exchange of Nonclinical Data (SEND) Implementation Guide for Animal Toxicology Studies can be obtained from the CDISC web site at: http://www.cdisc.org/models/send/v2.3/SENDV2.3ImplementationGuide.pdf

Study Data Specification:

The Study Data Specification for submitting SDTM datasets to CDER can be obtained at http://www.fda.gov/cder/regulatory/ersr/Studydata.pdf

Standard for Exchange of Non-Clinical Data:

The Standard for Exchange of Non-Clinical Data (SEND) is an implementation of the Study Data Tabulation Model for non-clinical studies

Janus Operational Pilot

CDISC Content to Message Project:

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) b) Eligibility Criteria c) Trial Design d) Statistical Analysis Plan
Study Participation	e) collected data/study data tabulations
Subject Data	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

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.

Resources:

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

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

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