Variable Definitions Batch 2

Comments Due By

CDISC invites you to submit comments on SDTM Variable Definitions Batch 2 during Public Review.

Batch 2 covers variables outside the general observation classes and the Demographics (DM) domain as well as variables either put on hold in the 2019 Batch 1 or added since then. Batch 2 also includes variables from all of the SDTM v2.0 tables, even though SDTM v2.0 has not yet been released.

  • Table 1 includes definitions for variables not included or placed on hold in Batch 1 (An Excel File of Table 1 is provided as an additional tool for review of this table.)
  • Table 2 includes variable definitions in Batch 1 for variables that appear in additional SDTM tables, and that were unchanged in the broader scope of Batch 2.
  • Table 3 includes variable definitions included in Batch 1 and updated in Batch 2. Many changes were due to the expanded scope (additional SDTM tables) of Batch 2.

View the draft: Variable Definitions - Batch 2

Instructions for providing comments: Instructions for Reviewers

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.