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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. Refer to both the CDASH Model and Appendix C, CDASH Model Metadata Tables.

   2. Follow 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) and align with CDISC NSV Registry conventions as applicable.

2. Select variables from the SDTM when fields from the CDASH Model cannot be used. Selection of variables must align with SDTM usage restrictions.

3. Create a new data applicant-defined collection field

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   when fields in the CDASH Model and variables from the SDTM cannot be used.

   1. When creating a new data applicant-defined collection field, determine whether the data will be used for an operational use case (e.g., data cleaning) or are to be represented in a tabulation dataset. In general, new data collection fields (not already defined in the CDASH Model) will fall in 1 of following categories:

      1. a field used for operational, data cleaningpurposes only;

      2. a field used to collect data that have direct mappingto a target variable in the tabulation dataset; or

      3. a field used to collect data that have no direct mapping to a target variable in the tabulation dataset.

   2. The following table provides implementation guidance aligned with both the category of the field and target variable.

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