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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. 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.

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 ScenarioCollection GuidanceIdentifies 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 NumberCollection GuidanceProvides 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 DefinitionCRF and System DesignProvides 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: 

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

Prompt 

CRF and System Design

Provides short phrases to prompt for data. Values in this column are:

  • Suitable as column headers.
  • Without text in brackets or parentheses to be used as-is
  • With text in brackets to be replaced with protocol-specified verbiage.
  • With text in parentheses indicating optional text.
  • With text with NULL indicating the prompt is not required on a CRF screen/page if not needed.
Data Type 

Tabulation Dataset Mapping

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 

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:

  • 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 InstructionsCollection GuidanceProvides 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:

  • 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

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). 



  • 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:CRF and System DesignThis 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 additional context for implementation of CRF data collection fields and mapping to tabulation datasets content may include:

  • Rationale
  • Implementation instructions
  • No labels