Study Data Tabulation Model

Metadata Submission Guidelines draft version 1.0  for SDTM IG V3.1.2 Call for Public Review

Comments due by 7 June 2010

The FDA can now accept SDTM V3.1.2. Please read the latest version of the Study Data Specifications (1.5.1) here.

In addition other documents related to the Study Data Standards Resources can be found here.

All available versions of the standards are below

Release of 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."