Where the SDTM provides a standard model for organizing and formatting data for human and animal studies, the SDTMIG is intended to guide the organization, structure, and format of standard clinical trial tabulation datasets. It was developed to support data submitted to a regulatory authority, such as the US Food and Drug Administration (FDA), but is not restricted to use in regulated submissions. SDTM is one of the required standards that sponsors must use as specified in the FDA’s Data Standards Catalog (see section II.C) for NDA, ANDA, and certain BLA submissions effective December 2016. For more information, please visit the Guidance on Standardized Data.


SDTMIG v3.3

3.3
Release Date: 20 Nov 2018

Version 3.3 of the Study Data Tabulation Model Implementation Guide for Human Clinical Trials (SDTMIG) is available in HTML format, which can be viewed in a browser.

Please log in or create an account to access the link to the Standard.

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. 

Enhancements, Key Additions and Revisions

SDTMIG v3.3 provides the following enhancements, key additions and revisions to prior versions:

  • Revised Disposition (DS) assumptions to facilitate greater clarity
  • Introduction of morphology/physiology domains to support specific body systems
  • New Functional Tests (FT) domain supporting QRS supplements
  • Expanded Disease Response and Clin Classification (RS) domain to include QRS clinical classification content
  • New class of Study References (e.g., Non-host Organism Identifiers)
  • Many new examples, revisions, and corrections across domains
  • New variables and assumptions for Demographics (DM)
  • Associations to supplemental implementation guides (e.g., SDTMIG-PGx, SDTMIG-MD)
  • Significant revisions to microbiology domains
  • Additional new supporting domains (e.g., ML, TM, SM)
  • Greater guidance on managing text strings that are more than 200 characters
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.


AttachmentSize
File SDTMIG v3.3 Public Review Comments149.89 KB

SDTMIG v3.2

3.2
Release Date: 26 Nov 2013

SDTMIG v3.2 Includes eleven additional domains: EC, PR, HO, DD, IS, MI, MO, RP, SR, SS, and TD. Re-designed as a PDF Portfolio instead of the traditional single PDF file**. Note: All previous annotations in SDTMIG 3.1.3, originally published in 2012, have been incorporated in SDTMIG v3.2.


AttachmentSize
PDF icon SDTMIG v3.2 (Single file)7.62 MB
PDF icon SDTMIG v3.2 (Portfolio)10.21 MB

SDTM v1.3 and SDTMIG v3.1.3

3.1.3
Release Date: 16 Jul 2012

SDTM v1.3 and SDTMIG v3.1.3 include:

  • Additional variables to the general observation classes for clinical and non-clinical trials
  • Content previously published in the SDTM Amendment 1
  • Changes to the trial design section
  • Document formatting updates
  • TU/TR/RS Oncology domains developed as the Oncology Disease-specific Therapeutic Area Supplement.

AttachmentSize
Package icon SDTM v1.3 and SDTMIG v3.1.321.64 MB

SDTMIG v3.2 Conformance Rules v1.0

1.0
Release Date: 27 Jan 2017

The SDTMIG v3.2 details the structure and conventions for compliant SDTM domains. The majority of the SDTMIG v3.2 is published in a data definition table format, which allows the information to be used programmatically. Business and conformance rules (e.g., assumptions and examples), however, are expressed outside of the data definition tables, making them difficult to identify and program.

SDTMIG v3.2 Conformance Rules v1.0 aim to identify all conformance rules and case logic from the SDTM and SDTMIG, classifying and codifying them in a form that supports SDTM quality processes and tool development. 

The Conformance Rules team has created a user guide that provides information on the structure of the rules and conventions for rules content. 

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