Page History
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Column | For | Purpose |
---|---|---|
Observation Class | Tabulation Dataset Mapping | Specifies the SDTM class for the domain. |
Domain | Tabulation Dataset Mapping | Specifies the 2-letter domain code. |
Data Collection Scenario | Collection Guidance | Indicates when a collection field should be used based on a specific context. Values in this column should be used with values in TIG Core to determine when a field should be present on a CRF. Values in this column are:
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Implementation Options | Collection Guidance | Indicates Specifies how to read/implement. When this column contains "Horizontal-Generic," a sampling of the CDASHIG metadata is provided as a template for the metadata of the CRF in a denormalized structure. Is this applicable to TIG specifications? |
Order Number | Collection Guidance | Provides a suggested order of fields to be displayed on a CRF. |
CDASHIG Variable | Tabulation Dataset Mapping | Provides the variable names. |
CDASHIG Variable Label | Tabulation Dataset Mapping | Provides the CDASHIG variable label. |
DRAFT CDASHIG Definition | CRF and System Design | Provides a draft definition of the CDASHIG variable to support for understanding and ensures proper usage |
Question Text | CRF and System Design | Provides full sentence/question forms to prompt for data. Values in this column are:
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Prompt | CRF and System Design | Provides short phrases to prompt for data. Values in this column are:
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Data Type | Tabulation Dataset Mapping | Specifies the data type of the variable. Values for in this column are:
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TIG Core | CRF and System Design | Specifies expectations for inclusion of fields on a CRF. Values in this column should be used with values in Data Collection Scenario to determine when a field should be present on a CRF. Values in this column are:
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Case Report Form Completion Instructions | Collection Guidance | Provides recommended example instructions to support authoring of study-level documentation for instructing sites how to complete CRF fields. |
Tabulation Target | Tabulation Dataset Mapping | This column provides the suggested mapping to the tabulation dataset variable. Values in this column are:
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Mapping Instructions | Tabulation Dataset Mapping | Provides information on the suggested mapping of the collection variable to the tabulation variable. |
Controlled Terminology Codelist Name | CRF and System Design | Specifies controlled terminology applicable to the field. Values in this column are:
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Subset Controlled Terminology/CDASH Codelist Name: | CRF and System Design | This column contains the CDISC CT or CDASH subset codelist name that may be used for that specific variable (e.g., EXDOSFRM). Link back to CT section. |
Implementation Notes | CRF and System Design | Provides additional context for implementation of CRF data collection fields and mapping to tabulation datasets content may include:
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