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Transfer 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.

Any CDASH domain that is available in the dataset can be split to include variables capturing data in some forms. As a result of the split, the variables can be transferred from a specific domain to an existing domain or a new one depending on the study requirements or data organization needs.

To transfer variables between dataset domains

  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 split.

  5. Then open More icon_more_actions.png option and select Transfer to a domain icon_transfer_dataset.png.

    Selecting option to split domain
    Figure 3. Selecting option to split domain

  6. At the first stage of the Transfer to a domain dialog that appears, select one of the following options:

    • Select a Domain: select one of the existing domains where you want to transfer form variables. Then select button_next_step.png.

      Selecting domain for transfer
      Figure 4. Selecting domain for transfer

    • Create a new Domain: select this option to specify a name and label for a new CDASH domain, which will be added to the dataset. Then select button_next_step.png.

      Creating domain for transfer
      Figure 5. Creating domain for transfer

  7. At the second stage of the Transfer to a domain dialog, select unique forms whose variables you want to transfer to the previously selected domain. Then select submit_button.png.

    Selecting forms for transfer
    Figure 6. Selecting forms for transfer

    Tip

    Each unique form contains questions that may be associated with variables and items that must be associated with variables. These associations exist to capture data that will be entered in the form of responses in the EDC system.

Once submitted, variables associated with the selected forms are transferred to an existing or new domain, depending on your transfer configuration.

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.