SDTM for Observational Studies v1.0

Comments Due By


CDISC is pleased to announce that version 1.0 of Considerations and Examples of Using SDTM for Observational Studies is entering the Public Review period to solicit your feedback.

The purpose of this document is to provide guidance for handling commonly encountered issues when using SDTM for observational research/real world data. The scope of version 1.0 is limited to SDTM and does not duplicate information found in the SDTM and SDTMIG. Rather, the focus is on concepts that require deviations from those documents or that require specialized implementation strategies.

View the draft: Considerations and Examples of Using SDTM for Observational Studies.

Instructions for providing comments: Instructions for Reviewers

Public Review closes 28 September 2023.

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

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.