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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 expectations for the CRF and data management system design, mapping of collected data in tabulation datasets, as well as completion instructions for individuals involved in data collection. The order of variables in a domain specification table reflects the expected order of variables in the resulting dataset. 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:

ColumnForPurpose
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
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

CRF and System Design

Provides suggested text for a collection question. Values in this column are complete sentences:

  • Without text in brackets or parentheses.
  • With text in brackets which should be replaced with protocol-specified verbiage.
  • With text in parentheses indicating the text is optional.
  • With text separated with a forward slash to indicate optional wording.

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:

  • Num for numeric data
  • Char for character or alphanumeric data
  • 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.

Specifies expectations for inclusion of the variable in the resulting dataset. Values in this column are:

  • Req for variables which are Required and must be included in the resulting dataset and cannot be null for any record. Such variables are basic to the identification of a data record or are necessary to make the record meaningful. 
  • Exp for variables which are Expected to be included in the resulting dataset, even if all values are null. Such variables are considered necessary to make the data record useful in the context of the domain.
  • Perm for variables for which it is Permissible to include or exclude the variable from the resulting dataset. Permissible variables must be included in the resulting dataset when data appropriate for the variable have been collected or derived, even if all values are null.
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:

  • N/A for when no direct mapping to a tabulation dataset variable is available.
  • SUPP–.QNAM for when a value represented in the field will be mapped to as a Supplemental Qualifier.
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). 



  • A single, required controlled term for the variable represented by the controlled term in double quotes. This value indicates the controlled term must be populated in the variable for all records in the resulting dataset.
  • Names of controlled terminology codelists with allowable terms to populate the variable. Codelist names are specified in paratheses. Multiple codelist names indicate the variable is subject to one or more of the codelists.
  • Names of formats to be applied to values in the variable.
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.

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