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Edit dataset domain

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 of the CDASH domains available in the dataset can be updated when a domain name or label needs to align with the latest industry or regulatory standards or for data harmonization purposes, especially in multistudy scenarios to facilitate cross-study comparisons and data pooling.

To edit a 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 domain you want to edit. Then next to the domain, select More icon_more_actions.png > Edit pencil_icon.png.

    Selecting option to edit domain
    Figure 3. Selecting option to edit domain

  5. In the Edit dialog that appears, update the domain as explained in the following table.

    Editing dataset domain
    Figure 4. Editing dataset domain

    Tip

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

    Element

    Details

    CDASH Domain*

    Enter an acronym for your domain.

    CDASH Label

    Enter the descriptive name for your domain.

    General Blind Domain

    Select this checkbox to blind all data elements associated with this domain. If cleared, the data is not blinded.

    Access Category*

    Select an existing access category or enter the name to create a new one for this domain data. Creating a custom category helps you effectively manage data blinding and granting access to specific users.

    SAVE

    Select save_button_red_white.png to implement the changes.

    CANCEL

    Select cancel_button_white_blue.png to discard the changes.

Once saved, the dataset domain details are 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.