Versions Compared

Old Version 71

changes.mady.by.user Christine Connolly

Saved on

compared with

New Version Current

changes.mady.by.user Christine Connolly

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

Metadata tables 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. Metadata tables Collection metadata for the TIG are provided in : Section

...

2.7.

...

6,

...

Metadata tables are organized by domain - table naming

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 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 options are applicable contained in a single cell, the options are 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 primarily guides one of the following aspects of data collection: table provides domain specific guidance for data collection, including guidance for:

  • CRF and System Design, with attributes to guide assist the development of the CRF(s) and the underlying database structure in conformance with the standard.
  • Tabulation Dataset Generationto guide development of programs to generate , with attributes to assist the electronic generation of tabulation datasets from compliant data . link between CDASH and SDTM
  • Data Collection Field Implementation to guide use of fields and facilitate creation of study-level documentation to support expected field completion.

.

  • (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: The columns in a metadata table are: use the across specs

Instructions in Column??
Metadataspec
NumMetadata Table Column Name
Column Purpose????
GuidancePurpose of Column Content
?
1Observation ClassTabulation 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).

2DomainTabulation Dataset Generation

Specifies the 2-letter domain code

.

3Data Collection Scenario
Data 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.

  

   

4

Implementation Options 

Data Collection Field Implementation

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.

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 
Is this applicable to TIG specifications? 
5Order Number
Data Collection Field Implementation
CRF and System DesignProvides a suggested order of fields to be displayed on a CRF
. 
6
Data
Collection VariableTabulation 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 DesignProvides the data collection variable label
.   
8DRAFT
TIG
Collection DefinitionCRF and System Design

Provides

a

the draft definition for the data collection variable to support understanding and intended usage.

This text may or may not mirror any text in the SDTMIG. Currently, there is a new CDASH/SDTM team creating variable definitions. Once these definitions are finalized, the CDASH definitions will be updated to harmonize with them.

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.In Findings domains, values from the relevant CDISC CT lists must also be used to create appropriate Question Text, Prompts, and/or variable names. For example, if the question is about the subject's height, incorporate the value of "Height" from the VSTEST codelist as the prompt on the CRF, and incorporate "HEIGHT" from VSTESTCD in the variable name
  • 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

, 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

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

11Data 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

TIG

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.

13Case Report Form Completion Instructions
Data Collection Field Implementation
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

14Tabulation 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 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 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). 

Link back to CT section.

  • 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

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
  • A description of condition(s) when the value of TIG CORE is R/C 
    • When the value in the TIG CORE column is R/C, conditions are described in the Implementation Notes column.
    • 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