CDISC Study Data Tabulation
Model / Submission Data Domain Models
Version 3.1
Version 3.1 of the CDISC Submission Data Domain
Standards has now been released for implementation
by the CDISC Submission Data Standards (SDS)
Team. Version 3.1 consists of two documents:
the Study Data Tabulation Model (SDTM), which
represents the underlying conceptual model behind
the SDS standards, and the CDISC V3.1 SDTM Implementation
Guide (SDTM-IG), which includes the detailed
domain descriptions, assumptions, and examples.
Both documents have been revised as of June
25, 2004 to incorporate comments received during
the comment periods from March-June 2004. The
review comments and associated responses are
also available for download. Comments on any
of these documents can continue to be submitted
through CDISC's public Discussion
Forum at any time. All comments will receive
responses and will be considered for inclusion
in future maintenance releases of the standard.
While Version 3.1 will be the stable baseline
for CDISC submissions standards, the SDS team
expects to release at least one maintenance
update later this year that will include additional
domain examples and extensions to the trial
design model.
A minor update of the document has been posted
as of July 15, 2004 to correct text errata.
Changed sections are listed in the cover page
and the footer date has been updated to identify
all significantly changed pages.
- Study Data Tabulation Model (SDTM), June
25, 2004
- Study Data Tabulation Model Implementation
Guide (SDTM-IG), July 14, 2004
- SDS V3.1 Review Comments and Responses Spreadsheet
Click here to register and download a zip file
of these 3 documents.
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