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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 or more rows for each standard 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 guidance for individuals involved in data collection. Metadata tables contain more than one row when... Multiple rows for are present - Columns describing CRF and data management system design are intended to assist the designers with 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 Guidance

Indicates when a collection field should be used based on a specific context. Values in this column should be used with values in TIG Core to determine when a field should be present on a CRF. Values in this column are:

  • A short description of the context in which the collection field should be present.
  • N/A for when no specific context for use applies to the collection field.

Implementation Options 

Collection Guidance

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? 

Order NumberCollection GuidanceProvides a suggested order of fields to be displayed on a CRF. 
CDASHIG Variable

Tabulation Dataset Mapping

Provides the variable names. 

CDASHIG Variable Label Tabulation Dataset MappingProvides the CDASHIG variable label.   
DRAFT CDASHIG DefinitionCRF and System DesignProvides a draft definition of the CDASHIG variable for understanding and 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 date

TIG Core 

CRF and System Design

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

  • HR for fields which are Highly Recommended and for which a data collection field should always be on the CRF.
  • R/C for fields which are Recommended/Conditional and for which a data collection field that should be on a CRF based on certain conditions.
  • O for fields which are Optional and for which a data collection field is available for use.
Case Report Form Completion InstructionsCollection Guidance

Provides recommended example instructions to support authoring of study-level documentation for instructing sites how to complete CRF fields.   

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:

  • 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.
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). 

Link back to CT section.

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
  • For any R/C fields, the "condition" is described in the Implementation Notes column of the CDASHIG metadata table.

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