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| Metadataspec |
|---|
| Standards for Collection | Standards for Tabulation | Standards for Analysis |
|---|
- 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 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
- Imputation flags for date and time imputations
- Subject status at different phases of the trial.
- Represent the derivation method Derivation Types for cases where imputation of data is doneimputation.
- Represent PARAM and PARAMCD values for analysis concepts contained in QRS instrumentsas applicable.
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Formats
Standards for tabulation and analysis require representation of dates and/or times, intervals of time, and durations of time in ISO 8601 format as defined by the International Organization for Standardization (ISO) (http://www.iso.org). The appropriate date and/or time ISO format must be used when specified. Additional ISO formats are referenced in this guide will be used as indicated in alignment with regulatory requirements.
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