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| Metadataspec |
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| Standards for Collection | Standards for Tabulation | Standards for Analysis |
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- To collect data values using terminology (e.g., Mild, Moderate, Severe)
- To ask a specific question on the CRF (e.g., Temperature)
- To create a variable name 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).
All codelists displayed in the CRF must use or directly map to the current published controlled terminology submission values, when it is available Subsets of published CT, such as those provided in CDASH terminology, can be used. | - To consistently represent applicable variable values.
- Coding...
- Standardizing to a unit...
Using Submission values? | |
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Controlled terminology from external sources...
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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 ISO format must be applied when specified.
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