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Add new visit

A visit refers to a scheduled appointment or meeting between a participant and the study team, usually at the trial site or designated healthcare facility. Visits play a crucial role in clinical trials by facilitating subject monitoring, data collection, treatment administration, adverse event reporting, and ensuring adherence to the protocol.

When first designing the study or introducing changes to suit the protocol changes, you can add new visits directly to the study or to the necessary cycle groups and visit folders.

Important

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

To add a new visit

  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, right click snd select one of the following entities:

    • Study name icon_study.png and then click new_visit.png.

    • Cycle group icon_cycle.png and then click new_visit_cycle.png.

    • Visit folder icon_folder.png and then click new_visit_folder.png.

  4. In the context menu that opens, select one of the following options:

    Adding new visit to study
    Figure 2. Adding new visit to study

  5. In the Add Visit panel that expands, fill in the form as explained in the following table.

    Adding new visit
    Figure 3. Adding new visit

    Tip

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

    Element

    Details

    Name*

    Represents a unique name for the created visit.

    Cycle

    Represents the cycle group name to which the visit is added considering the fact that the visit is being added to the cycle group. This field is always inactive.

    Parent Folder

    Here you can select the folder where the visit can be added. Ignore this field if you want to add a visit directly to the study.

    Type*

    From the dropdown list, select one of the following visit types:

    Category

    From the dropdown list, select one of the following categories: Screening, PreTreatment, Treatment, or FollowUp depending on what best describes the purpose of the created visit. You can also enter the custom category if needed.

    # of repeat visits*

    Represents the number of times the unscheduled visit needs to be repeated. The maximum number that can be entered here is 100. This field is available only if the Unscheduled visit type has been selected previously.

    User Added

    Switch this toggle on if you want to enable the functionality to manually add unscheduled visits in EDC.

    If turned off, EDC users cannot create new unscheduled visits for their subjects.

    This field is available only if the Unscheduled visit type is selected previously.

    SubType

    Select one of the following subtypes if applicable to the created visit:

    • eDiary: select this option if data is to be collected for the visit in the eClinical eDiary mobile application.

    • eCOA: select this option if data is to be collected for the visit in the eClinical eCOA mobile application.

    SAVE

    Select save_button_red_white.png to create the visit.

    CANCEL

    Select cancel_button_white_blue.png to cancel the visit creation process.

Once saved, the visit is added to the study, cycle, or folder. You now need to assign forms to this visit.

In this section:

In a clinical trial, a location where the subject treatment and drug dispensation occur. It can be a hospital, a private laboratory, or other institutions.

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.

Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

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 eClinical mobile application used for the collection and management of clinical data of subjects, supporting iOS and Android systems. It is based on the electronic CRF provided by the Study Designer application to support subjects' self-recording of treatment and diagnosis information.

An eClinical mobile application designed for the collection of clinical outcome assessments, such as patient-reported outcomes, questionnaires, and other data related to the participant's health, symptoms, or treatment experiences.