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Collection metadata in this guide are instructions for implementing the CDASH Model

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to develop CRFs and the underlying database or other data collection structure.Collection metadata for the TIG are provided in Section 2.7.6, Metadata for Individual Health. JirashowSummaryfalseserverIssue Tracker (JIRA)serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45keyTOBA-580. Guidance in this section describes how to read collection metadata provided in Section 2.7.6. Implementers should refer to Section 2.7.6 when reading this guidance.
Collection metadata will be used with all guidance in this section and are organized with 1 set of metadata per domain.All collection metadata begin with a description of the domain.
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A metadata specification follows A metadata table follows to describe data collection fields and their attributes. Assumptions for the domain are also provided to further guide implementation. Metadata specifications tables are structured to present 1 or more rows for each data collection field with columns to describe attributes for each field. More than 1 row will be present in a metadata specification table when data collection for a field can be performed using different scenarios/options. Multiple data collection options may also be provided in single cell within a row for a field with each option separated by a semicolon. JirashowSummaryfalseserverIssue Tracker (JIRA)serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45keyTOBA-396
Each column in a metadata specification table provides guidance which focuses 1 or more of following aspects of data collection
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domain specific guidance for data collection, including guidance for:
CRF and system design, which refers to System Design, with attributes to assist the development of the CRF(s) and the underlying database structure in conformance with the standard
Collection field implementation, which refers to use of fields and facilitate creation of study-level documentation to support expected field completion
Tabulation dataset generation, which refers to development of programs to generate Tabulation Dataset Generation, with attributes to assist the electronic generation of tabulation datasets from compliant data (e.g., via programming)
CRF Completion Instructions, to assist the creation of applicant documentation for instructing how to complete CRF fields
The columns present in a each metadata specification are: JirashowSummaryfalseserverIssue Tracker (JIRA)serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45keyTOBA-581table are described below with the column name, guidance, and purpose:
TOBA-397
Metadataspec
Num Metadata
Specification
Table Column Name
Focus of Column Content
Guidance Purpose of Column Content
1 Observation Class Tabulation
dataset generation
Dataset Generation
Specifies the SDTM class for the domain
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(see SDTM v2.1 Sections 2.1 and 3.1 for more information on Observation Classes).
2 Domain Tabulation
dataset generation
Dataset Generation
Specifies the 2-letter domain code
3 Data Collection Scenario
Collection field implementation
CRF and System Design
Specifies when there are different data collection contexts for collection fields in the same domain (e.g., central or local processing for collection of laboratory test results).
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Values
Values provide context for values in the TIG Core column to determine when a field should be present on the CRF. Values in this column are:
A short description of the data collection context
N/A for when only 1 context is provided for the domain
This column can be used to filter the metadata
specification
table for specific data collection scenarios when developing CRFs.
4
Implementation Options
CRF and
system design
System Design
Specifies when a sampling of
the
collection metadata is provided as a template for the metadata of the CRF in a denormalized structure.
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Values in this column are:
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NA to indicate data are collected in a normalized structure using a general variable for the name of the test and 1 variable for the collected results, resulting in a vertical dataset structure in which there is 1 record for each test/result
JirashowSummaryfalseserverIssue Tracker (JIRA)serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45keyTOBA-401
Horizontal-generic to indicate data are collected using a unique variable name for each test, resulting in a wide, horizontal dataset with multiple test results in each record
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5 Order Number
Collection field implementation
CRF and System Design Provides a suggested order of fields to be displayed on a CRF
6 Collection Variable Tabulation
dataset generation
Dataset Generation
Provides the data collection variable name
When the value in the Observation Class column is Findings
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, controlled terms must be incorporated into the data collection variable name.
7 Collection Variable Label
Tabulation dataset generation
CRF and System Design Provides the data collection variable label
8 DRAFT Collection Definition CRF and
system design
System Design
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.
9 Question Text CRF and
system design
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.
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The CDASH Model can be referenced to create conformant alternative question text.
10
Prompt
CRF and
system design
System Design
Provides short phrases
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to
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.
11 Data Type Tabulation
dataset generation
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
Collection Core
CRF and
system design
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.
13 Case Report Form Completion Instructions
Collection field implementation
CRF Completion Instructions
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
14 Tabulation Target Tabulation
dataset generation
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
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for
Text with the prefix SUPP for when the value of the data collection variable will be mapped as a supplemental qualifier.
15 Mapping Instructions Tabulation
dataset generation
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.
JirashowSummaryfalseserverIssue Tracker (JIRA)serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45keyTOBA-408

16 Controlled Terminology Codelist Name
CRF and
system design
System Design
Tabulation Dataset Generation
Specifies the name or names of the CDISC Controlled Terminology codelist or codelists associated with the data collection
field
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and
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
17 Subset Controlled Terminology/CDASH Codelist Name
CRF and
system design
System Design
Tabulation Dataset Generation
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
18
Implementation Notes
CRF and
system design
System Design
Tabulation
dataset generationCollection field implementation
Dataset Generation
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.

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Key

(see SDTM v2.1 Sections 2.1 and 3.1 for more information on Observation Classes).
2	Domain	Tabulation

Dataset Generation	Specifies the 2-letter domain code
3	Data Collection Scenario

table for specific data collection scenarios when developing CRFs.
4	Implementation Options	CRF and

CRF and System Design	Provides a suggested order of fields to be displayed on a CRF
6	Collection Variable	Tabulation

, controlled terms must be incorporated into the data collection variable name.
7	Collection Variable Label

CRF and System Design	Provides the data collection variable label
8	DRAFT Collection Definition	CRF and

System Design	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.
9	Question Text	CRF and

The CDASH Model can be referenced to create conformant alternative question text.
10	Prompt	CRF and

The CDASH Model can be referenced to create conformant alternative prompt text.
11	Data Type	Tabulation

CRF Completion Instructions	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
14	Tabulation Target	Tabulation

Text with the prefix SUPP for when the value of the data collection variable will be mapped as a supplemental qualifier.
15	Mapping Instructions	Tabulation

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
17	Subset Controlled Terminology/CDASH Codelist Name	CRF and