Module 12 Presentations

26/01/2024

ToxVision DataView

Information brought in from OWLOC (values of RIGHT, LEFT, BOTH for bilateral organs)

The Organisation for Professionals in Regulatory Affairs .

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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

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