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20 Apr ' 13:51
CDISC Study Data Tabulation Model (SDTM) v1.3 released for Public Review and Comment
The CDISC SDS Team is releasing SDTM v1.3 for a two week public review. This updated SDTM incorporates changes to the model that support a new Study Data Tabulation Model Implementation Guide (SDTMIG) v3.1.3 to be published at the end of May. The changes include: the addition of new variables to the general observation classes for both human clinical trials and SEND; the incorporation of the content previously published in the SDTM Amendment 1; changes to the Trial design section; and, contains document formatting updates.
The review package also includes the Oncology Disease-specific Therapeutic Area Supplement to the SDTM-IG in order to help provide context for some of the new variables. The oncology domains will be published later as part of the SDTM-IG v3.1.3 package. The Oncology Supplement has undergone a previous public comment period and so we are not looking for additional comments on that document at this time.
Follow this for full details.
PUBLIC REVIEW COMMENTS WILL BE ACCEPTED UNTIL MONDAY, 7 MAY 2012.
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