Module 12 2019

Submission Data Tabulation Model (SDTM)

SDTM is a standard way to organize and format the data that are collected during a study, so that data for the same TOPIC look the same from study to study, and from sponsor to sponsor Values of SDTM

SDTM is one of the required standards for data submission to FDA (U.S.) and PMDA (Japan)

The Organisation for Professionals in Regulatory Affairs