Metadata tables guide implementation of the CDISC CDASH model to develop CRFs and the underlying database or other data collection structure. Metadata tables for the TIG are provided in the following sections:
Metadata tables are structured to present one or more rows for each standard collection field with columns to describe expectations for the CRF and data management system design, mapping of collected data in tabulation datasets, as well as guidance for individuals involved in data collection. Metadata tables contain more than one row when... Multiple rows for are present - Columns describing CRF and data management system design are intended to assist the designers with remaining in conformance with the standard. When multiple options are contained in a single cell, the options are separated by a semicolon.
The columns in a metadata table are:
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 for understanding and 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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