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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.
- Refer to both the CDASH Model and Appendix x, CDASH Model Metadata Tables.
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 Appendix x, CDISC Variable-naming Fragments, conventions as applicable.
- Select variables from the SDTM when fields from the CDASH Model cannot be used. Selection of variables must align with SDTM Usage Restrictions.
Create a new data collection field when fields in the CDASH Model and variables from the SDTM cannot be used.
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:
A field used for operational, Data Cleaning purposes only.
A field used to collect data that have Direct Mapping to a target variable in the tabulation dataset.
A field used to collect data that have No Direct Mapping to a target variable in the tabulation dataset.
The table below provides implementation guidance aligned with both the category of the field and target variable.
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