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Metadata tables guide implementation of the CDISC CDASH model to develop CRFs and the underlying database or other data collection structure. Domain specifications Metadata tables for the TIG are provided in the following sections:

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Metadata tables are structured to present one row for each 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 collection guidance such as completion instructions for individuals involved in data collection. The order of variables in a domain specification table reflects the expected order of variables in the resulting datasetColumns describing CRF and data management system design are intended to assist the designers CRF(s) and the underlying database structures in remaining in conformance with the standard. When multiple options are contained in a single cell, the options are separated by a semicolon.

CRF and Data Management System Design Metadata

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The columns in a metadata table are:

Column	For	Purpose
Observation Class	Tabulation Dataset Mapping	Specifies the SDTM class for the domain.
Domain	Tabulation Dataset Mapping	Specifies the 2-letter domain code.
Data Collection Scenario	Collection Guidance	Identifies the different data collection options in CDASH for the same domain and is best used for filtering the table. The information in this column provides the context for the CDASHIG Core Designations (e.g., denoting which fields should be present on the CRF). When only 1 data collection scenario is provided for the domain, the column contains

"

N/A.

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Implementation Options	Collection Guidance	When this column contains "Horizontal-Generic," a sampling of the CDASHIG metadata is provided as a template for the metadata of the CRF in a denormalized structure.
Order Number	Collection Guidance	Provides a suggested order of variables to be displayed on a CRF.
CDASHIG Variable	Tabulation Dataset Mapping	Provides the variable names.
CDASHIG Variable Label		Provides the CDASHIG variable label.
DRAFT CDASHIG Definition	CRF and System Design	Provides a draft definition of the CDASHIG variable

.

to support understanding and ensures proper usage
Question Text	CRF and System Design	Provides

suggested text for a collection question

full sentence/question forms to prompt for data. Values in this column are

complete sentences

:

Without text in brackets or parentheses to be used as-is.
With text in brackets

which should

to be replaced with protocol-specified verbiage.
With text in parentheses indicating

the

optional text

is optional

.
With text separated with a forward slash

to indicate

indicating optional wording.

Prompt

Provides suggested text for the specific domain. Implementers should refer to the CDASH Model to create alternative prompt text that may be used that meets CDASH conformance rules. Prompt is a short version of the question. Some text is presented inside brackets [ ] or parentheses (). Text inside brackets should

CRF and System Design

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

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.

[NULL] in this column indicates that populating a

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.
Data Type	Tabulation Dataset Mapping	Specifies the data type of the variable. Values for in this column are: Num for numeric data Char for character or alphanumeric data Date Time
CDASHIG Core	CRF and System Design	This column contains the CDASHIG core designations for basic data collection fields (i.e., Highly Recommended (HR), Recommended/Conditional (R/C), Optional (O)). See Section 3.2, Core Designations for Basic Data Collection Fields. Specifies expectations for inclusion of the variable in the resulting dataset. Values in this column are: Req for variables which are Required and must be included in the resulting dataset and cannot be null for any record. Such variables are basic to the identification of a data record or are necessary to make the record meaningful. Exp for variables which are Expected to be included in the resulting dataset, even if all values are null. Such variables are considered necessary to make the data record useful in the context of the domain. Perm for variables for which it is Permissible to include or exclude the variable from the resulting dataset. Permissible variables must be included in the resulting dataset when data appropriate for the variable have been collected or derived, even if all values are null.
Case Report Form Completion Instructions	Collection Guidance	Provides recommended example instructions for the clinical site on how to enter collected information on the CRF.
Tabulation Target	Tabulation Dataset Mapping	This column provides the suggested mapping to the tabulation dataset variable. Values in this column are: N/A for when no direct mapping to a tabulation dataset variable is available. SUPP–.QNAM for when a value represented in the field will be mapped to as a Supplemental Qualifier.
Mapping Instructions	Tabulation Dataset Mapping	Provides information on the suggested mapping of the collection variable to the tabulation variable.
Controlled Terminology Codelist Name	CRF and System Design	Specifies controlled terminology applicable to the field. Values in this column are: In cases where a CDASH/CDASHIG variable has associated CT, the codelist is referenced in the Controlled Terminology column in the CDASH Model and CDASHIG metadata table in this format: (codelist name). A single, required controlled term for the variable represented by the controlled term in double quotes. This value indicates the controlled term must be populated in the variable for all records in the resulting dataset. 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. Names of formats to be applied to values in the variable.
Subset Controlled Terminology/CDASH Codelist Name:	CRF and System Design	This column contains the CDISC CT or CDASH subset codelist name that may be used for that specific variable (e.g., EXDOSFRM).
Implementation Notes

This column contains

CRF and System Design

Provides further information, such as rationale and implementation instructions, regarding how to implement the CRF data collection fields and how to map CDASHIG variables to SDTMIG variables.can assist a designer in determining the complete set of data to be collected on a form

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