In early 2009, CDISC released the SDTM v1.2 and the SDTMIG (SDTM Implementation Guide) v3.1.2. In this webinar presentation, we will provide information on the changes, additions, and enhancements made since the last releases (SDTM v.1.1 and SDTMIG v3.1.1) in mid-2005. Most changes have been designed with backward compatibility in mind.
Version 3.1.2 of the SDTMIG includes several domains that were released after Version 3.1.1 as well as domains that were completely new in version 3.1.2. These include Microbiology, Pharmacokinetics, Findings About, Clinical Events, Protocol Deviations, and Drug Accountability.
In addition, the SDS Team corrected known errors, and made many improvements to the SDTMIG document, including the following:
- Many general and domain-specific assumptions were added
- Existing assumptions were expanded or clarified
- Many more examples were added for previously published domains
- Domain examples were moved into the relevant domain section rather than appearing in a separate Examples section
Learning Objectives
Learn what is new in the SDTM v.1.2 and SDTMIG v3.1.2:
- Become familiar with the major changes to the SDTM v.1.2 and SDTMIG v3.1.2
- Learn about the new SDTMIG domains for Microbiology, Pharmacokinetics, and Clinical Events
- Understand how to use the new domain, Findings About
- Get an insight into the new Trial Design changes
Speakers
Chris Tolk, Director Terminology, CDISC
Fred Wood, Vice President, Data Standards Consulting, Octagon Research Solutions