SDTMIG: The Study Data Tabulation Model Implementation Guide (SDTMIG) for human clinical trials guides users on the organization, structure, and format of standard clinical study tabulation datasets for interchange between organizations or to be submitted to a regulatory authority.

The SDTMIG for Human Clinical Trials is based on the SDTM's general framework for organizing clinical trials information that is to be submitted to regulatory authorities.

2021年11月29日 · SDTMIG v3.4 provides specific domain models, assumptions, business rules, and examples for preparing standard tabulation datasets that are based on the SDTM. Noteworthy changes from the previous version (SDTMIG v3.3) include:

2018年11月20日 · Version 3.3 of the Study Data Tabulation Model Implementation Guide for Human Clinical Trials (SDTMIG) is available in PDF or HTML format. Enhancements, Key Additions and Revisions

2013年11月26日 · SDTMIG v3.2 is the implementation guide for Human Clinical Trials and corresponds with SDTM v1.4. SDTMIG v3.2 includes eleven additional domains: EC, PR, HO, DD, IS, MI, MO, RP, SR, SS, and TD.

Download SDTM v1.3 and SDTMIG v3.1.3 IMPORTANT: Please first read the PDF document “How to Use SDTMIG 3.1.3”, which provides information of the SDTMIG 3.1.3 documentation package.

About Mission & Roadmap CDISC Primer Global Regulatory Requirements Guiding Principles What's New Volunteering at CDISC Standards Foundational USDM SEND CDASH SDTM SDTMIG ADaM Analysis Results Medical Devices Tobacco IG Data Exchange ODM Define-XML Dataset-JSON Terminology Glossary Controlled Terminology Non Standard Variables …

2012年7月16日 · Version 3.1.3 of the Study Data Tabulation Model Implementation Guide (SDTMIG) for Human Clinical Trials corresponds to SDTM version 1.3. Updates to the guide and the model include:

2019年2月1日 · SDTMIG-MD v1.1 covers devices under investigation as well as ancillary devices in non-device trials, and is appropriate for regulatory submission and non-submission studies.

2021年11月29日 · The SDTM and SDTMIG Conformance Rules comprise all rules for the SDTM through version 2.0 and the SDTMIG through version 3.4. The Conformance Rules include 59 new rules, retirement of 49 rules as well as new versions …