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1. Using the root variables and other CDASH metadata in the CDASH Model, add any additional variables that are needed to meet the requirements of data collection.

   1. CDASH Model - Tobacco Implementation Guide (TIG) v1.0 - Wiki (cdisc.org)

   2. Follow Appendix x, CDISC Variable-naming Fragments conventions, and CDASH root variable-naming conventions where they exist (e.g., --DAT for dates, --TIM for times, --YN for prompts, as described in the CDASH Model). The Question Text and Prompt columns in the CDASH Model metadata provide different variations in the recommended text for asking the question on a CRF. For each question, the sponsor may elect to either use the Question Text or the Prompt on the CRF. Some text is presented using brackets [ ], parentheses ( ), and/or incorporating forward slashes. These different formats are used to indicate how the Question Text or Prompt may be modified by the sponsor.

Creating New Fields

When creating a new data collection field, determine whether the data will be used for an operational use case, such as data cleaning, or are actual data to be represented in a tabulation dataset. In general, new data collection fields (not already defined in the CDASH Model) will fall in one of following categories:

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