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Metadata tables guide implementation of the CDISC CDASH model Collection metadata in this guide are instructions for implementing the CDASH Model to develop CRFs and the underlying database or other data collection structure. Metadata tables Collection metadata for the TIG are provided in the following sections:

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 1 set of metadata per domain.All collection metadata begin with a description of the domain. A metadata table follows to describe data collection fields and their attributes.  Assumptions for the domain are also provided to further guide implementation. Metadata tables are structured to present one 1 or more rows for each standard data 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:

attributes for each field. More than 1 row will be present in a metadata 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. 

Each column in a metadata table provides domain specific guidance for data collection, including guidance for:

  • CRF and System Design, with attributes to assist the development of CRF(s) and the underlying database structure in conformance with the standard
  • 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 each metadata table are described below with the column name, guidance, and purpose: 

Tabulation Dataset Mapping
Metadataspec
NumMetadata Table Column NameGuidancePurpose of Column Content
1Observation ClassTabulation Dataset Generation
Metadataspec
ColumnForPurpose
Observation Class

Specifies the SDTM class for the domain

. 

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

2DomainTabulation Dataset
Mapping
Generation

Specifies the 2-letter domain code

.

3Data Collection Scenario
Collection GuidanceIndicates when a collection field should be used based on a specific context. Values in this column should be used with values in TIG Core
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). Values provide context for values in the TIG Core column to determine when a field should be present on

a

the CRF. Values in this column are:

  • A short description of the
context in which the collection field should be present.
  • data collection context
  • N/A for when
no specific
  • only 1 context
for use applies to the collection field.
  • is provided for the domain

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

4

Implementation Options 

Collection Guidance

Indicates Specifies how to read/implement.

When this column contains "Horizontal-Generic,"
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? 

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 
5Order NumberCRF and System Design
Order NumberCollection Guidance
Provides a suggested order of fields to be displayed on a CRF
. 
6
CDASHIG
Collection VariableTabulation Dataset
Mapping
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

names

name. 

7
CDASHIG
Collection Variable Label 
Tabulation Dataset Mapping
CRF and System DesignProvides the
CDASHIG
data collection variable label
.   
8DRAFT
CDASHIG
Collection DefinitionCRF and System Design

Provides

a

the draft definition

of

for the

CDASHIG

data collection variable

for

to support understanding and

proper usage

intended usage. Values in this column are further described in Section 1.5, Known Issues. 

9Question TextCRF 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
  • , 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
optional wording.
  • options for wording from which an implementer may choose. 

The CDASH Model can be referenced to create conformant alternative question text.

10

Prompt 

CRF and System Design

Provides short phrases to prompt for data. Values in this column are phrases:

  • Suitable as column headers.
    • 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

    The CDASH Model can be referenced to create conformant alternative prompt text.

    11Data Type Tabulation Dataset
    Mapping
    Generation

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

    • Num for numeric data
    • Char for character or alphanumeric date
    TIG

    12

    Collection Core 

    		CRF and System Design

    Specifies expectations for inclusion of

    fields

    the collection field on

    a

    the CRF. Values

    in this column should be

    are used with values in the Data Collection Scenario column to determine when a field

    should

    will be present on

    a

    the CRF. Values in this column are:

    • HR, for fields
    which
    • that are Highly Recommended and
    for which a data collection field
    • should always be included on the CRF
    .
    • R/C, for fields
    which
    • that are Recommended/Conditional and
    for which a data collection field that
    • should be included on
    a
    • the CRF
    based on
    • per certain conditions
    .
    • O, for fields
    which
    • that are Optional and
    for which a data collection field is available for use.
    • 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 Guidance
    CRF Completion Instructions

    Provides recommended example instructions for the data collection field to support authoring of study-level

    documentation

    instructions for

    instructing sites

    how to

    complete CRF fields. 

    enter collected information on the CRF

    14
     
    Tabulation Target Tabulation Dataset
    Mapping
    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 when the value of the data collection variable
    SUPP–.QNAM for when a value represented in the field
    • will be mapped
    to
    • as a
    Supplemental Qualifier
    • supplemental qualifier.   
    15Mapping InstructionsTabulation Dataset
    Mapping
    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. 

    16Controlled Terminology Codelist Name 

    CRF and System Design

    Specifies controlled terminology applicable to the field

    Tabulation Dataset Generation

    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:

    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.

    • 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

    This column contains the

    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
    name that may be used for that specific variable (e.g., EXDOSFRM). 
    • 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

    Link back to CT section.

    Implementation Notes 

    CRF and System Design

    Tabulation Dataset Generation

    Provides

    additional

    further context for implementation of

    CRF

    data collection fields and

    mapping to tabulation datasets content

    variables. Values in this column may include:

    • Rationale for implementation guidance
  • Implementation instructions
    • For any R/C fields, the "condition" is described in the Implementation Notes column of the CDASHIG metadata table.
    • 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