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Specification Table Column | Purpose |
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Variable Name | Specifies the name of the name of the variable which will be the name of the column in the resulting dataset. |
Variable Label | Specifies a descriptive label for the variable. |
Type | Specifies the data type of the variable. Values for in this column are:
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Controlled Terms, Codelist, or Format | Specifies any controlled terminology or formats that apply to the variable. Values in this column are:
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Role | Specifies the role of the variable in the resulting dataset. Values in this column are: SEE OBSERVATIONS AND VARIABLES IN SEND SECTION 2.4 |
CDISC Notes | Provides additional context regarding the intended use of the variable and may include:
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Core | Specifies the expectations for inclusion of the variable in the resulting dataset. Values in this column are:
SEE SEND see Section 4.1.3, Core Variables |
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- This may be the same as the label in the SDTM, or it may be customized for the domain.
- Sponsors should create an appropriate label if they include in a dataset an allowable variable not in the domain specification.
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SDTM - |
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- As noted in the table note, an asterisk (*) indicates that the variable may be subject to controlled terminology.
- The controlled terminology might be of a type that would inherently be sponsor-defined.
- The controlled terminology might be of a type that could be standardized, but for which a codelist not yet been developed.
- The controlled terminology might be terminology specified in value-level metadata.
- The name of an external code system (e.g., MedDRA) will be listed in plain text.
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- A hyperlinked codelist name in parentheses indicates that the variable is subject to the CDISC Controlled Terminology in the named codelist.
- Multiple hyperlinked codelist names indicate that the variable is subject to 1 or more of the named codelists from CDISC Controlled Terminology. If multiple codelists are in use for a single domain, value-level metadata would indicate where each codelist is applicable.
- A hyperlinked codelist name and an asterisk (*) indicate that the variable is subject to either the named codelist from the CDISC Controlled Terminology or to an external dictionary. The specific dictionary is identified in the metadata.
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- Role: This is taken directly from the SDTM. Note that if a variable is either a Variable Qualifier or a Synonym Qualifier, the SDTM includes the qualified variable, but SDTMIG domain specifications do not.
- CDISC Notes may include any of the following:
- A description of what the variable means
- Information about how this variable relates to another variable
- Rules for when or how the variable should be populated, or how the contents should be formatted
- Examples of values that might appear in the variable. Such examples are only examples, and although they may be CDISC Controlled Terminology values, their presence in a CDISC Note should not be construed as definitive. For authoritative information on CDISC Controlled Terminology, consult https://www.cancer.gov/research/resources/terminology/cdisc.
- Core: Contains 1 of the 3 values—"Req", "Exp", or "Perm"—explained further in Section 4.1.5, SDTM Core Designations.
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