Notes to Readers

• This is the implementation guide for Human Clinical Trials corresponding to Version 1.4 of the CDISC Study Data Tabulation Model.
• This Implementation Guide comprises version 3.2 (V3.2) of the CDISC Submission Data Standards and domain models.

Revision History

Date	Version	Summary of Changes
2013-11-26	3.2 Final	Contains the following major updates to the SDTMIG document structure in previous releases:

• Document has been split into smaller, more granular documents, and re-packaged as a PDF Portfolio
• Domains in Section 5 & 6 are now individual documents with clearly identified Definition, Specification, Assumptions & Examples sub-sections; numbering schema at the sub-section level has been removed for these domains.
• Main TOC does not contain page numbers
• Page numbering is relative to individual document, with clear notation of document content
• A small TOC has been inserted for Sections 5, 6.1, 6.2 and 6.3
• New HO Domain in Section 6.2
• New DD, IS, SR, RP, PR, MO, MI Domains in Section 6.3
• Other more granular updates as captured in Appendix E |