Amendment 1 to the Study Data Tabulation Model (SDTM) v1.2 and the SDTM Implementation Guide: Human Clinical Trials V3.1.2 Open for Public Review
The Submissions Data Standards Team is pleased to release this amendment for public review.
This document includes additional variables related to human clinical trials added at the request of FDA CDER and is being posted for comment and for trial use in advance of the next formal release of the SDTM and SDTMIG. Please provide review comments using the spreadsheet provided below by 26 May 2011.
For more information please click: CDISC SDTM
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