Version 1.0 of the Standard for Exchange of Nonclinical Data Implementation Guide: Animal Rule (SENDIG-AR) describes how to represent data for studies submitted under FDA regulations commonly known as the Animal Rule. The Animal Rule provides a regulatory mechanism for the approval of drugs and licensure of biological products when human efficacy studies are not ethical or feasible.
SENDIG-AR v1.0 is based upon, and should be used in close concert with, Version 1.8 of the Study Data Tabulation Model (SDTM) and Version 3.1 of the CDISC Standard for Exchange of Nonclinical Data Implementation Guide (SENDIG). Although the SENDIG v3.1 is based on SDTM v1.5, any data submitted under the Animal Rule should follow the conventions used in this implementation guide, and be based on SDTM v1.8.
CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.