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The columns in an ADaM dataset specification table are:
| Metadataspec |
|---|
| 1 | Variable Name | Specifies the name of the variable in the resulting dataset. | | 2 | Variable Label | Specifies a descriptive label for the variable. | | 3 | Type | Specifies the data type of the variable. Values for in this column are: - Num for numeric data
- Char for character or alphanumeric data
| | 4 | Controlled Terms, Codelist, or Format | Specifies applicable controlled terminology or formats with which to populate the variable. Values in this column are: - Names of one or more CDISC Controlled Terminology codelists with each codelist name in paratheses.
- Short references to an external terminology (e.g., MedDRA)
- The name of an external ISO 8601 format.
| | 5 | Core | Specifies expectations for inclusion of the variable in the resulting dataset. Values in this column are: - Req for variables which are Required and must be included in the resulting dataset - however unlike SDTM a required variable may be null for any record.
- Cond for variables which must be included in the dataset in certain circumstances.
- Perm for variables for which it is Permissible to include or exclude the variable from the resulting dataset.
| | 6 | CDISC Notes | Provides additional context for the intended use of the variable and may include: - A description of the purpose of the variable and/or what the variable means.
- Guidelines for variable use including rules for when or how the variable should be populated, or how the contents should be formatted.
- Example values which could appear in the variable. Such values are intended to support understanding and are not intended to influence decisions regarding what values must be captured in the variable.
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| 1 | Variable Name | Specifies the name of the variable in the resulting dataset. |
| 2 | Variable Label | Specifies a descriptive label for the variable. |
| 3 | Type | Specifies the data type of the variable. Values for in this column are: - Num for numeric data
- Char for character or alphanumeric data
|
| 4 | Controlled Terms, Codelist, or Format | Specifies applicable controlled terminology or formats with which to populate the variable. Values in this column are: - Names of one or more CDISC Controlled Terminology codelists with each codelist name in paratheses.
- Short references to an external terminology (e.g., MedDRA)
- The name of an external ISO 8601 format.
|
| 5 | Core | Specifies expectations for inclusion of the variable in the resulting dataset. Values in this column are: - Req for variables which are Required and must be included in the resulting dataset - however unlike SDTM a required variable may be null for any record.
- Cond for variables which must be included in the dataset in certain circumstances.
- Perm for variables for which it is Permissible to include or exclude the variable from the resulting dataset.
|
| 6 | CDISC Notes | Provides additional context for the intended use of the variable and may include: - A description of the purpose of the variable and/or what the variable means.
- Guidelines for variable use including rules for when or how the variable should be populated, or how the contents should be formatted.
- Example values which could appear in the variable. Such values are intended to support understanding and are not intended to influence decisions regarding what values must be captured in the variable.
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