- Ask specific questions on the CRF (e.g., Temperature)
- Collect data values using terminology (e.g., Y or N)
- Name variables in the operational database (e.g., TEMP_VSORRES for the collection of vital sign data when a unique variable name must be created for each vital sign result).
| - Name domain datasets and variables in datasets when applicable.
- Represent collected, assigned, and derived values in datasets.
| - Represent the level of imputation for numeric date/time variables.
- Represent the subject status at different phases of the trial.
- Represent the derivation method for cases of data imputation.
- Represent values for analysis concepts as applicable.
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