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If data are in scope for a domain defined in this guide , but not all data can be collected using the domain's collection fields, then fields may be added from the CDASH Model, the SDTM, or created using guidance belowin the TIG.
Prior to adding fields from the CDASH Model, the SDTM, or considering a new field, confirm that none of the fields in the domain will fit the need. Fields may be added from the CDASH Model, the SDTM, or created only when data are different in nature and are not in scope for collection fields in this guide.
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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 C, 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 CDISC Non-Standard Variables NSV Registry 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 Restrictionsusage 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 (e.g., 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 1 of following categories:
A a field used for operational, Data Cleaning data cleaningpurposes only.;
A a field used to collect data that have Direct Mapping direct mappingto a target variable in the tabulation dataset.; or
A a field used to collect data that have No Direct Mapping no direct mapping to a target variable in the tabulation dataset.
The following table below provides implementation guidance aligned with both the category of the field and target variable.
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