Metadata tables guide implementation of the CDISC CDASH to build datasets for representation of collected or derived data. Domain specifications for the TIG are provided in the following sections:
| Column | Purpose |
|---|---|
| Observation Class | Specifies the SDTM class for the domain. |
| Domain | Specifies the 2-letter domain code. |
| Data Collection Scenario | Identifies the different data collection options in CDASH for the same domain and is best used for filtering the table. The information in this column provides the context for the CDASHIG Core Designations (e.g., denoting which fields should be present on the CRF). When only 1 data collection scenario is provided for the domain, the column contains "N/A." |
Implementation Options | 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. |
| Order Number | Provides a suggested order of variables to be displayed on a CRF. |
| CDASHIG Variable | Provides the variable names. |
| CDASHIG Variable Label | Provides the CDASHIG variable label. |
| DRAFT CDASHIG Definition | Provides a draft definition of the CDASHIG variable. |
| Question Text | Provides suggested text for a collection question. Values in this column are:
|
Prompt | This column provides suggested text for the specific domain. Implementers should refer to the CDASH Model to create alternative prompt text that may be used that meets CDASH conformance rules. Prompt is a short version of the question. Some text is presented inside brackets [ ] or parentheses (). Text inside brackets should be replaced with protocol-specified verbiage. [NULL] in this column indicates that populating a prompt is not required on a CRF screen/page if not needed. |
| Data Type | This column contains the simple data type of the CDASH variable (i.e., Char, Num, Date, Time). |
CDASHIG Core | This column contains the CDASHIG core designations for basic data collection fields (i.e., Highly Recommended (HR), Recommended/Conditional (R/C), Optional (O)). See Section 3.2, Core Designations for Basic Data Collection Fields. |
| Case Report Form Completion Instructions | This column contains recommended example instructions for the clinical site on how to enter collected information on the CRF. |
| SDTMIG Target | This column provides the suggested mapping to the SDTMIG variable name. It may help facilitate the creation of the SDTMIG variables needed for submission. When no direct mapping to an SDTMIG variable is available, the column contains "N/A". When the column contains "SUPP--.QNAM", it means that that the value represented in the CDASH field shall be mapped to an SDTM Supplemental Qualifier. |
| Mapping Instructions | This column contains information on the suggested mapping of the CDASHIG variable to the SDTMIG variable. Mapping instructions in the CDASHIG metadata tables provide more complete guidance than that in the CDASH Model. When domain-level metadata are not available, consult the CDASH Model for SDTM mapping instructions. |
| Controlled Terminology Codelist Name | This column contains the CT codelist name (e.g., "LOC") that is associated with the field. The SDTMIG indicates that certain variables (e.g., dates) use ISO formats as CT. However, in CDASH these variables are generally not collected using ISO CT, but rather are converted to the ISO format when the SDTM-based submission datasets are created. |
| Subset Controlled Terminology/CDASH Codelist Name: | This column contains the CDISC CT or CDASH subset codelist name that may be used for that specific variable (e.g., EXDOSFRM). |
Implementation Notes | This column contains further information, such as rationale and implementation instructions, regarding how to implement the CRF data collection fields and how to map CDASHIG variables to SDTMIG variables. |
Note: When multiple options are contained in a single cell, the options are separated by a semicolon.
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