Evolution of SDTMIG 3.1.1 to 3.1.2: A mapping specialist must reference on these changes

With the evolution of changes to the SDTM data standards model which incorporated in minor and major changes to the Classes, Domains, Variables, Controlled Terminology and its respective assumptions in SDTMIG 3.1.2 version has played a great deal of efforts for a mapping specialist to understand these evolving changes and their respective principals been implementation in compliance to these data standards and keep themselves updated on this knowledgebase with their ongoing work with in the industry to keep them in par with the competitive global market. This paper will further dive into the details of the new domains incorporated in the current version and also give an overview and details on their structure and its respective implementation with real case scenarios. The purpose of this presentation is to benefit the user by providing a clear comparison of changes incorporated to these standards and its impact to implemented standards in previous versions and also discusses further on the new guidelines outlines on which observation class the data belongs to was not part of the previous versions of implementation guide.