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Collection metadata in this guide are instructions for implementing the CDASH model Model to develop CRFs and the underlying database or other data collection structure.Collection metadata for metadata for the TIG are provided in : Section

...

2.7.

...

6, Metadata for Individual Health. 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 guidance in this section and are organized with one 1 set of metadata per domain.All collection metadata begin with a description and overviewof the domain. A metadata table follows table follows to describe data collection fields and their attributes. Assumptions Assumptions for the domain are also provided to further guide implementation. Metadata tables are structured to present one 1 or more rows for each data collection field with columns to describe attributes for each field. More than one 1 row will be present in the a metadata table when there is more than one data collection scenario for a field can be performed using different scenarios/options. Multiple data collection field. When more than one option is applicable in a single cell, semicolons are used to separate discreet options.options may also be provided in single cell within a row for a field with each option separated by a semicolon.

Each column in a metadata table provides guidance which focuses one or more of following aspects of data collection. domain specific guidance for data collection, including guidance for:

CRF and System Design which refers to , 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 , 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 table are described below with the column name, guidance, and purpose:

Indicates Specifies how to read/implement.

Metadataspec

Num

Metadata Table Column Name

Focus of Column Content

Guidance	Purpose of Column Content
1	Observation Class	Tabulation Dataset Generation	Specifies the SDTM class for the domain

.

(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

Collection Field Implementation

CRF and System Design

Specifies

the

when there are different data collection

context

contexts for

which the collection field can be present on the CRF. Values are used with

collection fields in the same domain (e.g., central or local processing for collection of laboratory test results). Values provide context for values in the TIG Core column to determine when a field

will

should 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.

data collection context
N/A for when only

one

1 context is

applicable.

provided for the domain

This column can be used to filter the metadata table

when developing CRFs

for specific data collection scenarios when developing CRFs.

When this column contains "Horizontal-Generic,"


4	Implementation Options

Collection Field Implementation

CRF and System Design

Specifies when

a sampling of

the CDASHIG
collection metadata is provided as a template for the metadata of the CRF in a denormalized structure.
Is this applicable to TIG specifications? refer to:
Values in this column are:
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
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
https://www.cdisc.org/kb/articles/sdtm-and-cdash-why-you-need-both
5 Order Number
Collection Field Implementation
CRF and System Design Provides a suggested order of fields to be displayed on a CRF
.
6
Data
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 the data collection variable name.
7
Data
Collection Variable Label
Tabulation Dataset Generation
CRF and System Design Provides the data collection variable label
.
8 DRAFT
TIG
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
further described in Section
x
1.
x
5, Known Issues.
9 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 indicate
, 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
to indicate
, 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.
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.
11 Data 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
Collection 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.
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
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
.
Text with the prefix SUPP for
SUPP–.QNAM for
when the value of the data collection variable will be mapped as a
Supplemental Qualifier
supplemental qualifier.
15 Mapping Instructions 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.
16 Controlled Terminology Codelist Name
CRF and System Design
Tabulation Dataset Generation
Specifies the name or names of the CDISC
controlled terminology
Controlled Terminology codelist or codelists associated with the data collection
field and
field and variable. Values in this column are:
The codelist name in parentheses, when
one
1 codelist is associated
.
Codelist names in parentheses separated by commas, when more than
one
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
Tabulation Dataset Generation
Specifies CDISC
controlled terminology
CT terms or the name of the CDASH subset codelist
or codelists that may be used for
associated with the data collection field and variable.Values in this column are:
CDISC
A controlled terminology
terms?
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
CDASH subset codelist names in parentheses separated by commas when more than one codelist may be used?
N/A

for when specific controlled terms or CDASH subset terminology are not applicable
.
18
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:
Rationales
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

5, Known Issues.
9	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

. The CDASH Model can be referenced to create conformant alternative question text.
10	Prompt	CRF and System Design	Provides short phrases


14	Tabulation 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

supplemental qualifier.
15	Mapping Instructions	Tabulation Dataset Generation	Provides information on the suggested mapping of the data collection variable to the tabulation variable.