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Edit item

The Study Designer application enables study teams to configure CRFs for clinical trial visits with a variety of tools. There are various form field options such as text fields, checkboxes, dropdown menus, date pickers, and more. You can place these fields on the form canvas, arrange them as needed, and make sure they are associated with the corresponding variables.

When maintaining a form, it may occur that some question items need to be updated due to the modified protocol requirements or other reasons specified by the sponsor. Once the item is updated, the changes will be reflected accordingly on the form after it is published to EDC.

To edit an item of the question

  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, expand the unique form directory of any visit. Then select the needed form.

    Important

    Note that by updating a unique form, you introduce changes to all visit forms linked to it and vice versa.

    Accessing form to configure
    Figure 2. Accessing form to configure

  4. On the form content page that appears, next to the needed item, select More icon_more_actions.png > Edit Item pencil_icon.png.

    Tip

    When dealing with the checkbox item, the Edit Item option is intended for the update of a single checkbox option. To edit the entire checkbox item, you need to select Edit Checkbox Group pencil_icon.png.

    Selecting option to edit item
    Figure 3. Selecting option to edit item

  5. In the Update Item panel that expands, update the general details of the item under the Generate tab and the variable definition under the Definition tab. The elements available under both tabs differ depending on the item type as specified in the following table.

    Editing item example
    Figure 4. Editing item example

    Item type

    Details

    Label

    The details of this item are explained in the respective tables of the Add label item to question section:

    Text

    The details of this item are explained in the respective tables of the Add text item to question section:

    Text Area

    The details of this item are explained in the respective tables of the Add text area item to question section:

    Listbox

    The details of this item are explained in the respective tables of the Add listbox item to question section:

    Radio

    The details of this item are explained in the respective tables of the Add radio item to question section:

    Checkbox

    The details of this item are explained in the respective tables of the Add checkbox item to question section:

    Time

    The details of this item are explained in the respective tables of the Add time item to question section:

    Date

    The details of this item are explained in the respective tables of the Add date item to question section:

    Integer

    The details of this item are explained in the respective tables of the Add integer item to question section:

    Float

    The details of this item are explained in the respective tables of the Add float item to question section:

    Slider

    The details of this item are explained in the respective tables of the Add slider item to question section:

    Body Image

    The details of this item are explained in the respective tables of the Add body image item to question section:

    Reference

    The details of this item are explained in the respective tables of the Add reference item to question section:

    Unit

    The details of this item are explained in the respective tables of the Add unit item to question section:

  6. Select save_button_red_white.png to implement the changes.

Once saved, the item details are updated. You can now continue to maintain forms with available actions.

In this section:

A specialized document in a clinical trial designed to collect the subject data.

See also eCRF.

Any person, company, institution, group, or organization that is a client of EDETEK and a user of the eClinical system.

In the eClinical system, the Sponsor role is assigned to the user who oversees or pays for a clinical trial and collects and analyzes the data. Before the study goes live, the Sponsor users work closely with the data managers, configuring CRFs and other aspects to make sure everything meets their requirements before giving the green light for the study to go live. In the course of a trial, the Sponsor users make requests for amendments in the system according to a new protocol version, changes in business requirements, or other needs.