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.

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SENDIG-DART v1.1

Errata

An erratum (plural: errata) is a correction to a mistake made in a published standard, which was identified after it was published on the CDISC website, and which would have been corrected in the current version had it been identified prior to publication. Updates, revisions, substantive corrections, and other changes of enough significance to require a cycle through the Standards Development Process are not errata, and thus are not included on the pages below.