Implementation Advice for this Model

The SDTM has been designed to accommodate the broadest range of human and nonclinical study data in a standardized manner. This document describes the basic concepts and general structure of the model. Individual implementation guides (IGs) have been created to provide specific recommendations for numerous domains of data commonly collected in human, nonclinical, and medical device studies, identifying which variables from a general observation class may apply. These IGs also describe basic assumptions and business rules, and provide numerous examples for mapping data to the standard format. Sponsors wishing to represent data in the standard formats should consult the IGs before preparing datasets based on the SDTM. The following implementation guides have been published by CDISC:

• The Study Data Tabulation Model Implementation Guide for Human Clinical Trials (SDTMIG) https://www.cdisc.org/standards/foundational/sdtmig
• The Study Data Tabulation Model Implementation Guide for Medical Devices (SDTMIG-MD) https://www.cdisc.org/standards/foundational/sdtm-ig-md
• The Study Data Tabulation Model Implementation Guide: Associated Persons (SDTMIG-AP) https://www.cdisc.org/standards/foundational/sdtmig/sdtmig-ap
• The Standard for Exchange of Nonclinical Data Implementation Guide (SENDIG) https://www.cdisc.org/standards/foundational/send
• The Standard for Exchange of Nonclinical Data Implementation Guide: Developmental and Reproductive Toxicology (SENDIG-DART) https://www.cdisc.org/standards/foundational/send/sendig-dart
• The Standard for Exchange of Nonclinical Data Implementation Guide: Animal Rule (SENDIG-AR) https://www.cdisc.org/standards/foundational/send/sendig-animal-rule
• The Tobacco Implementation Guide (TIG) 

In addition to the IGs, CDISC implementation advice is contained in:

• Multiple indication-specific therapeutic area user guides (TAUGs; https://www.cdisc.org/standards/therapeutic-areas), which provide examples and implementation advice for various therapeutic areas.
• Supplements for individual questionnaires, ratings, and scales (QRS; https://www.cdisc.org/foundational/qrs), which provide information on how to structure the data in a standard format for public domain and copyright-approved instruments. 
• The CDISC Controlled Terminology website page (https://www.cdisc.org/standards/terminology/controlled-terminology).