How to Read Collection Metadata

Collection metadata in this guide are instructions for implementing the CDASH model 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.

Collection metadata will be used with all guidance in this section and are organized with one set of metadata per domain. All collection metadata begin with a description. A metadata specification follows to describe data collection fields and their attributes. Assumptions are also provided to further guide implementation. Metadata are structured to present one or more rows for each data collection field with columns to describe attributes for each field. More than one row will be present in the metadata specification when there is more than one data collection scenario for a data collection field. When more than one option is applicable in a single cell, semicolons are used to separate discreet options.

Each column in a metadata table provides guidance which focuses one or more of following aspects of data collection.

CRF and System Design which refers to 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 datasets from compliant data.

The columns in a metadata specification are:

Num	Metadata Table Column	Focus of Column Content	Purpose of Column Content
1	Observation Class	Tabulation Dataset Generation	Specifies the SDTM class for the domain.
2	Domain	Tabulation Dataset Generation	Specifies the 2-letter domain code.
3	Data Collection Scenario	Collection Field Implementation	Specifies the data collection context for which the collection field can be present on the CRF. Values are used with values in the TIG Core column to determine when a field will 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. N/A for when only one context is applicable. This column can be used to filter the metadata table when developing CRFs for specific data collection scenarios.
4	Implementation Options	CRF and System Design	Specifies options for the implementation of collection variables for the CRF. Values in this column are: N/A to indicate variables are implemented in a normalized vertical structure, with 1 record for each observation, similar to a tabulation dataset. Horizontal-Generic to indicate variables are implemented in a denormalized horizontal structure, with one variable for each part of an observation. Denormalized TIG Collection Variable names generally use the following the naming convention: <TIG Tabulation Topic Variable value>_<Qualifier(s)>_<TIG Tabulation Target variable>. Applicants may define their own conventions for creating denormalized TIG Collection Variable names.
5	Order Number	Collection Field Implementation	Provides a suggested order of fields to be displayed on a CRF.
6	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 data collection variable name.
7	Collection Variable Label	Tabulation Dataset Generation	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 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 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 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	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. SUPP–.QNAM for when the value of the data collection variable will be mapped as a 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	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: The codelist name in parentheses when one codelist is associated. Codelist names in parentheses separated by commas when more than one 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	Specifies CDISC controlled terminology 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 Tabulation Dataset Generation Collection Field Implementation	Provides further context for implementation of data collection fields and variables. Values in this column may include: Rationales 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.

Page tree

How to Read Collection Metadata