Study Data Tabulation Model Metadata Submission Guidelines v2.0

Comments Due By

CDISC invites you to provide comments on  version 2.0 of Study Data Tabulation Model Metadata Submission Guidelines (SDTM-MSG) during Public Review.

Description

The purpose of SDTM-MSG v2.0 is to provide guidance for preparing the components of the International Conference on Harmonisation (ICH) electronic Common Technical Document (eCTD) Module 5 (M5) Clinical Study Reports "sdtm" folder. This document and the associated example submission package illustrate the components recommended for electronic submission of SDTM data. These guidelines are based on Define-XML v2.1, SDTM v1.7/SDTMIG v3.3, and SDTM Terminology 2020-03-27.

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Public review is a key quality step in our Standards Development Process. CDISC relies on your input to ensure neutral, consensus-based data standards are developed and adopted by a diverse global community interested in improving research processes and quality for the benefit of all.

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