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This is the landing page for SDTM Variable Definitions. 

Notes for Reviewers

  1. If reviewers would like additional information on the guidelines the team followed for defining definitions, please look at the kickoff slides.
  2. We suggest that reviewers review the definitions in conjunction with the information in the CDISC notes/description columns located in published CDISC implementation guides and models. While these definitions are not intended to supplant the information in the notes/descriptions column, the information provided therein may provide some valuable context that will help with definition review. We have provided a CDISC notes/description column in the review table, however that content may have changed over time so please refer to published CDISC standards documents for the latest information.
  3. We suggest that reviewers look at the definition without looking at the variable name, to see if they can ascertain the variable name from the definition. If the reviewer cannot ascertain the variable name from the definition, then that definition might need clarification.
  4. An Excel version of the table has been provided as a review tool, allowing reviewers to filter on related variable names or similar phrasing.
    1. A JIRA issue should be created for all comments, using the Variable Definitions Project in JIRA.
    2. Reviewers should not make comments in the Excel spreadsheet.
  5. The review should focus on the definitions in the Final Definition column of the table. Comments on information in other table columns will be noted, but changes to the information in the other columns in the table are not within the scope of the Variable Definitions Team.
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