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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.
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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.
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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: 

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table are described below with the column name, guidance, and purpose: 

Metadataspec
NumMetadata
Specification
Table Column Name
Focus of Column Content
GuidancePurpose of Column Content
1Observation ClassTabulation
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).

2DomainTabulation
dataset generation
Dataset Generation

Specifies the 2-letter domain code

3Data 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

options

when a sampling of collection metadata is provided as a template for the

implementation

metadata of

collection variables for the CRF
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the CRF in a denormalized structure. Values in this column are:

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  • 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 naming convention:
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    <TIG Tabulation Topic Variable value>_<Qualifier(s)>_<TIG Tabulation Target variable>

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      • Applicants may define their own conventions for creating denormalized TIG collection variable names.
    The general structure of tabulation datasets uses a normalized structure. In a normalized structure data are collected

     

    • 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
    data
    • dataset structure in which there is 1 record for each test/result
    . This is denote using N/A in this CDASH column. When a deformalized structures are used,
    • 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. This is denoted using Horizontal-Generic.

    These seem to be options for variable names, One option is for variable names in a structure that matches the SDTM structure, while the other is a variable name within a denormalized structure.

    Horizontal (Denormalized) and Vertical Data Structures (Normalized) 

    In the CDASHIG metadata tables, many of the CDASH Findings class domains are presented in a normalized structure (1 record for each test) that is similar to the SDTM, even though many data management systems hold the data in a denormalized structure (1 variable for each test). When implementing CDASH in a denormalized structure, create variable names for the Findings --TEST and/or --TESTCD values. To do this, define the denormalized variable names using available CDISC Controlled Terminology for --TESTCD. Alternatively, CDASH variable names for data management systems allowing more than 8-character variable names can use CDASH variables using the following naming convention: <--TESTCD>_<-- SDTM variable name> where --TESTCD is the appropriate CT for the test code (e.g., DIABP_VSORRES, DIABP_VSLOC). Other naming convention may be used. See the CRFs in Section 8.3.18, Vital Signs, for examples of CDASH variable naming conventions.   
    • record 
    5Order Number
    Collection field implementation
    CRF and System DesignProvides a suggested order of fields to be displayed on a CRF
    6Collection VariableTabulation
    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. 

    7Collection Variable Label 
    Tabulation dataset generation
    CRF and System DesignProvides the data collection variable label
    8DRAFT Collection DefinitionCRF 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. 

    9Question TextCRF 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.

    11Data Type Tabulation
    dataset generation
    Dataset Generation

    Specifies the data type of the variable. Values for in this column are:

    Num for
    • 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.

    13Case 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

    14Tabulation 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.   
    15Mapping InstructionsTabulation
    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.

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    16Controlled 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
    17Subset 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. 

    Pagenav