CDISC Study Data Tabulation Model Implementation Guide V3.1.2 Draft
CDISC Study Data Tabulation Model Version 1.2 Draft

The SDTM Implementation Guide, Version 3.1.2

The CDISC Submission Data Standards (SDS) Team has released a draft version of the SDTM Implementation Guide (SDTMIG) for Human Clinical Trials, Version 3.1.2, for public review and comment. Reviewers are asked to submit comments by the close of business on Friday, September 28, 2007.  A final version is expected to be available in early 2008.

Changes in SDTMIG Version 3.1.2 from Version 3.1.1 have been made based upon industry feedback and previously identified needs. These include recommended solutions for signs and symptoms, findings about events or interventions, questions with multiple answers, and questions such as “other, specify". Version 3.1.2 contains new domains such as those for PK and Microbiology and includes more examples for previously published domains.

Along with the SDTMIG V3.1.2, the review package (SDTMIG v3.1.2_SDTM v1.2 Review Package.zip) includes Notes for Reviews and an Excel spreadsheet for submitting comments. The latter highlights some of the most important changes in Version 3.1.2 from the previous version and request specific feedback on several important questions and issues that are still under consideration by the SDS Team.

The SDTM Version 1.2

The SDTM Version 1.2 been released by the CDISC Submission Data Standards (SDS) Team for public review and comment. This version of the SDTM has undergone only minor changes (corrections and the addition of several new allowable variables) since Version 3.1, and is still the foundation for the SDTM Implementation Guide. Reviewers are asked to submit comments using the spreadsheet in the review package (SDTMIG v3.1.2_SDTM v1.2 Review Package.zip) by the close of business on Friday, September 28, 2007.

• SDTMIG V3.1.2 and SDTM V1.2 Review Package (zip)

Go to CDISC Public Discussion Forums