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Tabulation dataset generation

Specifies the SDTM class for the domain

Tabulation dataset generation

Specifies the 2-letter domain code

Specifies the data collection context for which the collection field can be present on the CRF.

• A short description of the context in which the field can be present on the CRF
• N/Afor when only 1 context is applicable

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

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Implementation Options 

Specifies options for the implementation of collection variables for the CRF

• N/A to indicate variables are implemented in a normalized vertical structure

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  , with 1 record for each observation, similar to a tabulation dataset
• Horizontal-genericto indicate variables are implemented in a denormalized horizontal structure, with 1 variable for each part of an observation
  • Denormalized TIG collection variable names

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    generally use the following the naming convention:

<TIG Tabulation Topic Variable value>_<Qualifier(s)>_<TIG Tabulation Target variable>

• • Applicants may define their own conventions for creating denormalized TIG collection variable names.

Tabulation dataset generation

Provides the data collection variable name

When the value in the Observation Class column is Findings

Provides the draft definition for the data collection variable to support understanding and intended usage. Values in this column are further described in Section 1.5, Known Issues. 

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, indicating an option on the verb tense of the question or text that can be replaced with protocol-specified verbiage or controlled terminology
• With text in parentheses, indicating options for text (e.g., singular/plural) or optional text that may be omitted
• With text separated with a forward slash, indicating options for wording from which an implementer may choose.

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.

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Prompt 

CRF and system design

Provides short phrases, suitable as column headings, 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.

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

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Collection Core 

CRF and system design

Specifies expectations for 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.

Provides recommended example instructions for the data collection field to support authoring of study-level instructions for how to enter collected information on the CRF

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 the value of the data collection variable will be mapped as a supplemental qualifier

Tabulation dataset generation

Provides information on the suggested mapping of the data collection variable to the tabulation variable. Additional guidance for mapping values may be described in the Implementation Notes column. The CDASH Model can also be referenced for suggested mapping.

CRF and system design

Specifies the name or names of the CDISC Controlled Terminology codelist or codelists associated with the data collection field and variable. Values in this column are:

• The codelist name in parentheses, when 1 codelist is associated
• Codelist names in parentheses separated by commas, when more than 1 codelist is associated
• N/A for when controlled terminology is not associated with the data collection field and variable

Specifies CDISC CT terms or the name of the CDASH subset codelist associated with the data collection field and variable.Values in this column are:

• A controlled terminology term or a subset of terms from the codelist referenced in the Controlled Terminology Codelist Name column
• The name of the CDASH subset codelist in parentheses
• N/A for when specific controlled terms or CDASH subset terminology are not applicable

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Implementation Notes 

CRF and system design

Tabulation dataset generation

Collection field implementation

Provides further context for implementation of data collection fields and variables. Values in this column may include:

• Rationale for implementation guidance
• Additional instructions for implementing fields and variables on the CRF and in the underlying database structure
• Example values which could appear in the in the data collection field and variable
• Additional guidance for mapping values from data collection to tabulation variables

Example values provided are intended to support understanding and are not intended to influence decisions regarding what data to collect. For guidance on the selection of data to collect, please refer to the appropriate regulatory authority.