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Edit dataset variable

A dataset is a visual representation of columns and rows in CDASH domains based on the configuration of forms. Each column in the dataset represents a CDASH variable that captures data in corresponding rows as per record ID settings. In Study Designer, a dataset is not the actual data storage as it serves solely to show how data is structured when entered in forms of the EDC system.

Each variable in any of the CDASH domains available in the dataset can be updated due to evolving study requirements. These updates may also be necessary in order to align with the expected data entry processes within EDC.

Tip

Each variable can be associated with various questions and items across different forms. These associations exist to capture data that will be entered in the form of responses in the EDC system.

To edit a variable in the dataset domain

  1. In the Study Designer application header, select the CRF DESIGN tab.

  2. In the toolbar, select the latest draft CRF version marked with the respective unlock symbol unlocked_icon_purple.png, otherwise, you cannot perform any actions.

    Selecting latest draft CRF version
    Figure 1. Selecting latest draft CRF version

  3. From the workspace toolbar of the hierarchy tree, select Dataset icon_datasets.png.

    Accessing dataset page
    Figure 2. Accessing dataset page

  4. In the left pane of the page that opens, select the needed domain.

  5. In the header of the table that appears, open More icon_more_actions.png option next to the needed variable and select Edit pencil_icon.png.

    Selecting option to edit variable
    Figure 3. Selecting option to edit variable

  6. In the Edit dialog that appears, update the CDASH variable details as explained in the following table.

    Editing variable
    Figure 4. Editing variable

    Tip

    In the following table, mandatory elements are marked with an asterisk (*).

    Element

    Details

    CDASH Variable*

    Update the original name of the variable.

    Data Type*

    Select the type of data that is to be collected for questions or items associated with the variable.

    Length*

    Update the maximum number of characters or digits that the field can capture when entering data in EDC.

    CDASH Label*

    Update the original label of the variable.

    SAVE

    Select save_button_red_white.png to update a variable.

    CANCEL

    Select cancel_button_white_blue.png to cancel updating a variable.

Once saved, the CDASH variable is updated.

In this section:

A specific area or category of data within a clinical trial that encompasses a set of related variables that share a common theme. Each domain organizes data to facilitate analysis and reporting, ensuring that information is structured and easily interpretable.

For example, in a clinical trial, domains might include demographics, efficacy, safety, and laboratory results.

An eClinical application that is mainly used to collect and manage subject data during clinical trials. It integrates with the Study Designer (SD) application and uses preconfigured there case report forms (CRFs) to complete data collection and management. It also provides an audit trail, data alert, source data verification (SDV), payment management, adjudication, and other functions as well as supports data export according to the CDISC ODM standard.

Get to know all the possibilities of the app with the comprehensive EDC User Guide.