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Add cycle group

A cycle refers to the planned sequence of treatments and recovery periods that participants undergo during the study. In Study Designer, the cycles can be added only within the dedicated cycle groups that need to be created first.

Important

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

To add a cycle group

  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 and in the context menu that opens, select New Cycle icon_cycle.png.

    Selecting to add new cycle group
    Figure 2. Selecting to add new cycle group

  4. In the Add dialog that appears, enter a unique group name for the created cycle.

    Adding cycle group to study
    Figure 3. Adding cycle group to study

  5. Select save_button_red_white.png to add a new cycle group to your study.

Once saved, the cycle group is added to the study. You now need to define cycle of assessment and define cycle group details.

In this section:

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.