This is the landing page for the current working version of the SDTM Metadata Submission Guidelines (SDTM-MSG) document.
- Read the SDTM-MSG
There are two options, depending on your reading preference:
- SDTM-MSG compiled — This lets you view the entire document as a single web page.
SDTM-MSG sections — This displays each section on its own page, and comprises the source of the content displayed on the compiled view.Jump to a specific section:
- Define-XML Document
- Annotated CRF
- Clinical Study Data Reviewers Guide
- Submission Datasets
- Trial Design
- Special-Purpose Domains
- Review the sample submission package
Other resources you may find useful:
- Reading on the Wiki — This page touches on some of the ways the Wiki edition of the SDTM-MSG has been optimized for web use, with which a reader new to the CDISC Wiki may be unfamiliar.
- The Study Data Tabulation Model (SDTM) can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/sdtm.
- SDTM-MSG v1.0 can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig/metadata-submission-guideline-msg-sdtmig