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SDTM V1.2 & SDTM IG V3.1.2

CDISC is pleased to announce the posting of the Study Data Tabulation Model, Version 1.2 (SDTM v1.2) and the SDTM Implementation Guide for Human Clinical Trials (SDTMIG v.3.1.2). FDA announced on 6 November 2009 that they will accept SDTM V3.1.2 submissions. Please note the following taken directly from the document: Sponsors "should discuss with the review division the datasets that should be provided, the data elements that should be included in each dataset, and the organization of the data within the file. Additionally, not all FDA centers have adopted all aspects of these specifications; sponsors are advised to discuss with the reviewing division data needs prior to preparing data for submission."

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