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 row for each data 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 collection guidance such as completion instructions for individuals involved in data collection. Columns describing CRF and data management system design are intended to assist the designers CRF(s) and the underlying database structures in remaining in conformance with the standard. When multiple options are contained in a single cell, the options are separated by a semicolon.
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 | 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 | 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 | Collection Guidance | 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 | Collection Guidance | Provides a suggested order of variables to be displayed on a CRF. |
| CDASHIG Variable | Tabulation Dataset Mapping | Provides the variable names. |
| CDASHIG Variable Label | Provides the CDASHIG variable label. | |
| DRAFT CDASHIG Definition | CRF and System Design | Provides a draft definition of the CDASHIG variable to support 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:
|
Prompt | CRF and System Design | Provides short phrases to prompt for data. Values in this column are:
|
| Data Type | Tabulation Dataset Mapping | Specifies the data type of the variable. Values for in this column are:
|
CDASHIG Core | CRF and System Design | 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 | Collection Guidance | Provides recommended example instructions for the clinical site on how to enter collected information on the CRF. |
| Tabulation Target | Tabulation Dataset Mapping | This column provides the suggested mapping to the tabulation dataset variable. Values in this column are:
|
| 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: 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: | 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). |
Implementation Notes | CRF and System Design | Provides 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.can assist a designer in determining the complete set of data to be collected on a form |
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