SDTM Metadata Submission Guidelines v2.0

Published Date:

Version 2.0 of the Study Data Tabulation Model Metadata Submission Guidelines: Human Clinical Trials (SDTM-MSG) provides 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.

Sample Submission Package

The Sample Submission Package consists of new or revised datasets, annotated CRF, submission components and a study data reviewer’s guide. The Guidelines and the Sample Submission Package illustrate the components recommended for the submission of SDTM data.

Public Review Comments

CDISC posts public review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.