CDISC invites you to provide comments on version 2.0 of Study Data Tabulation Model Metadata Submission Guidelines (SDTM-MSG) during Public Review.
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.
To Provide Comments:
- View the draft: SDTM Metadata Submission Guidelines Home
- Instructions for providing comments: Instructions for Reviewers
- CDISC is hosting a Public Review webinar 24 Sept 11:00 AM - 12:30 PM Eastern US Standard Time REGISTER NOW
You will need to log in or register for the CDISC Wiki to provide comments.
- Register for the Wiki. If you already have an account on Wiki or JIRA, our issue-tracking system, simply log in to your account; Wiki and JIRA use the same login credentials. CDISC Wiki is a different login from www.cdisc.org.
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.
Thank you for contributing your time and expertise.