SDTM v1.7


Published Date:

Version 1.7 of the SDTM is available in HTML format. SDTM v1.7 supports SDTMIG v3.3; a complete description of all changes from the prior version is provided in Section 7 of the document.

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HTML Format

This release 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.

Public Review Comments

CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.


Files

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HTML Document

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SDTMIG v3.3
SDTMIG for Medical Devices v1.1
Conformance Rules v1.1 for SDTMIG v3.2 and v3.3
SDTM Metadata Submission Guidelines v2.0

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.