Module 12 Presentations

26/01/2024

SDTM Background - continued

 Defines Study Data Tabulations only ● Tabulation = collected data ● In SAS Transport (XPT) format ● Analysis datasets are still submitted separately ● Patient profiles and listings will be produced by FDA standard tools

 Domains modeled in Implementation Guides

The Organisation for Professionals in Regulatory Affairs .

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FDA Tools: Patient Profile Viewer

v1.1a SEND Training

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