CDISC Study Data Tabulation
Model
Version 1.1 Draft
Version 1.1 Draft of the CDISC Study Data Tabulation
Model (SDTM) is now posted for comment by the
CDISC Submission Data Standards (SDS) Group.
Version 1.1 includes seven new variables that
have been included for non-clinical and clinical
data applications and one new Trial Summary
dataset (that is part of the Trial Design Model).
A separate update to the Implementation Guide
for Human Clinical Trials to support this SDTM
update will be released shortly by the SDS team.
An implementation guide, the Standard for Exchange
of Non-clinical Data, is already posted at http://www.cdisc.org/models/send/
v2/index.html. Comments on SDTM Version
1.1 Draft will be accepted until close of business
on Friday, February 25, 2005. Comments on both
documents can be submitted through the CDISC
Discussion Board at http://www.cdisc.org/discussions/discussions.html.
•Study Data Tabulation Model
(SDTM) Draft Version 1.1, January 25, 2005 (pdf)
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