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Add visit folder

In Study Designer, you can add visit folders—dedicated directories to store related visits, for instance, unscheduled visits that need to be repeated according to the study protocol.

As an example, a study can contain the Tumor Response Assessment folder where you can add many tumor response assessment visits. Such visits may include the radiology report, target or non-target lesion assessment, and new lesion assessment forms. The purpose of these visits could be to assess the response of the brain tumor to the investigated drug. Only a healthcare professional performing the assessment can enter data into the indicated forms in EDC.

Important

For master study and its substudies, you need to create the visit folders individually, they are not inherited from the master study to its substudies.

To add a visit folder

  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. In the left pane that appears, right-click the study name.

  4. In the context menu that opens, select New Folder icon_form_new.png.

    Selecting to add new folder
    Figure 2. Selecting to add new folder

  5. In the Add dialog that appears, enter a unique name for the folder you create.

    Adding folder to study
    Figure 3. Adding folder to study

  6. Select save_button_red_white.png to add a new folder to your study.

Once saved, the folder is added to the study. You can now add visits to this folder.

In this section:

A visit that occurs outside of the predefined schedule as the subject or the study staff initiates them in response to emerging symptoms, adverse events, or other issues that require immediate attention. Unscheduled visits are conducted to address participant concerns, assess unexpected reactions, or collect additional data not initially planned in the visit structure.

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.

An overarching clinical trial protocol designed to achieve clinical trial objectives under a unified framework. This approach simplifies clinical development by introducing multiple substudies to operate under the same regulatory and operational entity.

An individual component of a master study protocol with its specific objectives, such as evaluating a product, dose, or subject category. Substudy inherits the core structure and governance from the master one but has its own endpoints.