Module 12 Presentations

26/01/2024

FDA Reviewing Tools

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Copyright 2009 Octagon Research Solutions, Inc. All rights reserved

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SDTM Documentation to be aware of

Study Data Tabulation Model v1.8 SDTM Implementation Guide for Human Clinical Trials V3.3 SEND Implementation Guidev3.1.1 Also SENDIG-DARTv1.1 and SENDIG-GeneTx1.0

● Detailed description of model fundamentals ● Detailed description of model assumptions ● Domain models and implementation examples More on SEND a bit later…

The Organisation for Professionals in Regulatory Affairs .

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