Study Data Tabulation Model Implementation Guide: Human Clinical Trials

1 Introduction

1.1 Purpose

This document comprises the CDISC Version 3.2 (V3.2) Study Data Tabulation Model Implementation Guide for Human Clinical Trials (SDTMIG), which has been prepared by the Submissions Data Standards (SDS) team of the Clinical Data Interchange Standards Consortium (SDTM Terminology). Like its predecessors, V3.2 is intended to guide the organization, structure, and format of standard clinical trial tabulation datasets submitted to a regulatory authority such as the US Food and Drug Administration (FDA). V3.2 supersedes all prior versions of the Study Data Tabulation Model Implementation Guide for Human Clinical Trials (SDTMIG).

1.2 Organization of this Document

This document is organized into the following sections:

• Section 1 - Introduction, provides an overall introduction to the V3.2 models and describes changes from prior versions.

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