Metadata tables guide implementation of the CDISC CDASH model to develop CRFs and the underlying database or other data collection structure. Domain specifications for the TIG are provided in the following sections:
Metadata tables are structured to present one row for each data collection field with columns to describe expected attributes of the field and mapping of collected data in resulting datasets. The order of variables in a domain specification table reflects the expected order of variables in the resulting dataset.
CDASHIG metadata table attributes provide building blocks for the development of a CRF and the underlying database or other data-collection structure.
CRF and Data Management System Design Metadata
Certain metadata attributes are essential to CDASH conformance. Combined with the variable naming conventions discussed in Section 5.1, Conformance Rules, these metadata attributes will assist the designer of the CRF(s) and the underlying database structure in remaining in conformance with the standard:
- Question Text (full sentence/question forms to prompt for data) OR Prompts (short phrases, often suitable as column headers, to prompt for data)
- CDISC Controlled Terminology lists and subsets of list values, when applicable
- DRAFT CDASH Definition (to assist in understanding the purpose of each variable, which ensures proper usage and simplifies subsequent pooled data analyses)
- CDASHIG Core Designations and Implementation Notes (which, when used together, can assist a designer in determining the complete set of data to be collected on a form)
SDTMIG Programming Metadata
Columns in the CDASHIG metadata tables that will assist in developing programs to generate SDTM domain datasets from CDASHIG-compliant data include:
- Domain
- CDASHIG Variable
- Data Type
- SDTMIG Target
- Mapping Instructions
- Controlled Terminology Codelist Name
- Subset Controlled Terminology/CDASH Codelist Name
- Implementation Notes
Additional Metadata
Clear and consistent completion instructions for sites help to ensure collection of quality, reliable data, a critical factor in the development of high-quality pooled/submission data. The CDASHIG metadata tables include the Case Report Form Completion Instructions column to assist authors in creating this study-level documentation for instructing sites how to complete CRF fields.
The columns in a metadata table are:
| 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 complete sentences:
|
Prompt | 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 | Specifies the data type of the variable. Values for in this column are:
|
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. Specifies expectations for inclusion of the variable in the resulting dataset. Values in this column are:
|
| Case Report Form Completion Instructions | Provides recommended example instructions for the clinical site on how to enter collected information on the CRF. |
| Tabulation Target | This column provides the suggested mapping to the tabulation dataset variable. Values in this column are:
|
| Mapping Instructions | Provides information on the suggested mapping of the collection variable to the tabulation variable. |
| Controlled Terminology Codelist Name | Specifies controlled terminology applicable to the field. Values in this column are: In cases where a CDASH/CDASHIG variable has associated CT, the codelist is referenced in the Controlled Terminology column in the CDASH Model and CDASHIG metadata table in this format: (codelist name).
|
| 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. |
Overview
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