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Define cycle of assessments

A cycle refers to the planned sequence of treatments and recovery periods that participants undergo during the study. During the cycle, subject data is collected at various visits to assess the investigational product's efficacy and safety.

After the cycles have been added to the study, you can define assessments for these cycles. The cycle of assessments implies the association of cycle visits with forms. Each form includes questions that the subjects need to answer when attending cycle visits on a scheduled basis.

Important

Before defining the cycle of assessments, you need to add visits to the study and associate forms with these visits.

To define a cycle of assessments
  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, select the cycle group where the forms need to be associated with cycle visits.

  4. On the page that opens, select the Cycle of Assessments tab.

  5. In the table that appears, associate cycle visits with forms by selecting corresponding checkboxes as suggested in the following figure.

    Defining cycle assessments
    Figure 2. Defining cycle assessments

    Tip

    The list of forms available for selection is populated from the Unique Form folder of your study. If you need some other forms to be added to cycle visits, consider adding new unique forms.

  6. Select save_icon_red.png to apply the cycle of assessments.

Once saved, the cycle of assessments is defined.