How to Use Metadata Tables

Metadata tables are instructions for implementation of the 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:

Individual Health Metadata

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:

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	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 Number	Collection Guidance	Provides 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 Mapping	Provides the CDASHIG variable label.
DRAFT CDASHIG Definition	CRF and System Design	Provides 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. In Findings domains, values from the relevant CDISC CT lists must also be used to create appropriate Question Text, Prompts, and/or variable names. For example, if the question is about the subject's height, incorporate the value of "Height" from the VSTEST codelist as the prompt on the CRF, and incorporate "HEIGHT" from VSTESTCD in the variable name.
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. 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 Instructions	Collection 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 A description of condition(s) when the value of TIG CORE is R/C

Page tree

How to Use Metadata Tables