SDTM v1.6


Published Date:

SDTM v1.6 supports the SENDIG-DART v1.1 and includes additional variables related to developmental and reproductive toxicology (DART) animal studies. A full description of all changes from the prior version is provided in Section 7. 

SDTM v1.6 is published in HTML format, which expedites delivery of the standard and is viewable in any standard browser. HTML format allows users to search for keywords within the page, and bookmark the information in a browser. Implementers can also print the page, or export the information into other formats (e.g., PDF). To save a copy of the HTML publication on your desktop to access the document offline, press CTRL-S (PC) or COMMAND-S (Mac) on your keyboard.

CDISC Library

If your organization is a CDISC Member,  you can access machine-readable, normative metadata content via CDISC Library and associated resources.