Foundational Standards

Foundational Standards


Foundational Standards released this quarter:

Confirmed Data Endpoints for Exchange (CoDEx) for SENDIG v3.1 Data

Version 1.0 of the CoDEx for SENDIG v3.1 clarifies which study designs and study endpoints were intended to be standardized in the Standard for Exchange of Nonclinical Data Implementation Guide (SENDIG) Version 3.1.

 

SENDIG-Animal Rule v1.0

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.

 

SDTM v1.8

Version 1.8 of Study Data Tabulation Model (SDTM) includes additional variables to meet the need for domain models described in the Standard for Exchange of Nonclinical Data Implementation Guide: Animal Rule v1.0 (SENDIG-AR v1.0).