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Metadata tables are instructions for implementing the CDASH model to develop CRFs and the underlying database or other data collection structure. Metadata tables for the TIG are provided in:


Metadata tables are organized by domain - table naming

Metadata tables are structured to present one or more rows for each data collection field with columns to describe attributes for each field. More than one row will be present in the metadata table when there is more than one data collection scenario for a data collection field. When more than one options are applicable contained in a single cell, the options are separated by a semicolon.

Each column in a metadata primarily guides one of the following aspects of data collection: 

  • CRF and System Design to guide development of the CRF(s) and the underlying database structure in conformance with the standard.
  • Tabulation Dataset Generation to guide development of programs to generate tabulation datasets from compliant data. link between CDASH and SDTM
  • Data Collection Field Implementation to guide use of fields and facilitate creation of study-level documentation to support expected field completion.

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The columns in a metadata table are: use the across specs

NumColumnColumn Purpose????Instructions in Column???
1Observation Class

Tabulation Dataset Generation

Specifies the SDTM class for the domain. 

2Domain

Tabulation Dataset Generation

Specifies the 2-letter domain code.

3Data Collection ScenarioData Collection Field Implementation

Specifies the data collection context for which the collection field can be present on the CRF. Values are used with values in the TIG Core column to determine when a field will be present on the CRF. Values in this column are:

  • A short description of the context in which the field can be present on the CRF.
  • N/A for when only one context is applicable.

This column can be used to filter the metadata table when developing CRFs for specific data collection scenarios.  

4

Implementation Options 

Data Collection Field Implementation

Indicates Specifies how to read/implement.

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.

Is this applicable to TIG specifications? 

5Order NumberData Collection Field ImplementationProvides a suggested order of fields to be displayed on a CRF. 
6Data Collection Variable

Tabulation Dataset Generation

Provides the data collection variable name. 

When the value in the Observation Class column is Findings, controlled terms must be incorporated into data collection variable name. 

7Data Collection Variable Label Tabulation Dataset GenerationProvides the data collection variable label.   
8DRAFT TIG DefinitionCRF and System Design

Provides the draft definition for the data collection variable to support understanding and intended usage. Values in this column are:

9Question 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 or controlled terminology.
  • With text in parentheses indicating optional text.
  • With text separated with a forward slash indicating options for wording from which to choose from.

When the value in the Observation Class column is Findings, controlled terms must be used to create question text for the data collection field on the CRF. 

The CDASH Model can be referenced to create conformant alternative question text.

10

Prompt 

CRF and System Design

Provides short phrases, suitable as column headers, to prompt for data. Values in this column are phrases:

  • Without text in brackets or parentheses to be used as-is
  • With text in brackets to be replaced with protocol-specified verbiage or controlled terminology.
  • 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.

When the value in the Observation Class column is Findings, controlled terms must be used to create prompt text for the data collection field on the CRF. 

The CDASH Model can be referenced to create conformant alternative prompt text.

11Data Type 

Tabulation Dataset Generation

Specifies the data type of the variable. Values for in this column are:

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

12

TIG Core 

CRF and System Design

Specifies expectations for the inclusion of the collection field on the CRF. Values are used with values in the Data Collection Scenario column to determine when a field will be present on the CRF. Values in this column are:

  • HR for fields that are Highly Recommended and should always be included on the CRF.
  • R/C for fields that are Recommended/Conditional and should be included on the CRF per certain conditions.
  • O for fields that are Optional and should be included on the CRF when needed to support data collection.

When the value in this column is R/C, conditions are described in the Implementation Notes column.

13Case Report Form Completion InstructionsData Collection Field Implementation

Provides recommended example instructions to support authoring of study-level documentation with which to instruct sites how to complete CRF fields.   


Provides recommended example instructions to support authoring of study-level documentation to instruct how collected information should be entered  how to complete CRF fields.   for how to enter collected information on the CRF.

Provides recommended example instructions to support authoring of study-level documentation


Recommended example instructions for the clinical site on how to enter collected information on the CRF  


Provides recommended example instructions to support authoring of study-level documentation with which to instruct sites on how to enter collected information on the CRF.








14Tabulation Target 

Tabulation Dataset Generation

This column provides the suggested mapping to the tabulation dataset variable. Values in this column are:

  • The name of the tabulation dataset variable to which the value of the data collection variable will be mapped.
  • 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.
15Mapping Instructions

Tabulation Dataset Generation

Provides information on the suggested mapping of the collection variable to the tabulation variable. 

16Controlled Terminology Codelist Name 

CRF and System Design

Specifies controlled terminology applicable to the field. Values in this column are:

  • 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.
17Subset Controlled Terminology/CDASH Codelist NameCRF 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). 

Link back to CT section.

18

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
  • A description of condition(s) when the value of TIG CORE is R/C 


When the value in the TIG CORE column is R/C, conditions are described in the Implementation Notes column.



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