  |
CDISC SDTM Implementation Guide V3.1.1 Final & Version 1.1 FinalCDISC SDTM Implementation Guide V3.1.1 FinalVersion 3.1.1
(V3.1.1) of the CDISC Study Data Tabulation Model Implementation Guide:
Human Clinical Trials has been released by the CDISC Submission Data
Standards (SDS) Team. V3.1.1 is based upon Version 1.1 of the SDTM,
which was posted in May, 2005. This newest version includes new
features, corrections, clarifications, and examples, all of which are
described in detail in Section 10.6 of the document. V3.1.1 also
includes a new domain model for Protocol Deviations, which is posted
separately. Although V3.1.1 represents the most current, approved
version of the SDTMIG, the SDS Team will continue to work on providing
additional examples to represent more complex data domains such as
signs and symptoms, pharmacokinetic concentrations and parameters, and
microbiology. In addition, the team plans to continue work on
developing additional models and examples for intervention and event
data that include both spontaneous and pre-specified treatments and
terms. Comments on this released version can be posted through the
CDISC Discussion Board.
CDISC Study Data Tabulation Model Version 1.1 FinalVersion 1.1 (Final) of the CDISC Study Data Tabulation Model (SDTM), prepared by the CDISC Submission Data Standards (SDS) Group, is now available for use. Version 1.1 includes seven new variables that have been included for non-clinical and clinical data applications and the new Trial Summary dataset (that is part of the Trial Design Model). This final version includes several minor corrections and clarifications (listed in Section 6.3) to address issues raised during the comment period, but no major changes. Sponsors who wish to contribute comments for consideration for future versions of the SDTM may do so through the CDISC Discussion Board.
|