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Add label item to question

In Study Designer, study teams have a variety of tools to configure case report forms (CRFs) for data collection. There are various items— text fields, checkboxes, dropdown menus, date pickers, and more—that you can add as form fields next to their respective questions. You can place these fields on the form canvas, arrange them as needed, and make sure they are associated with the corresponding variables. This provides flexibility to outline the way each question must be answered by the user, and how the data must be stored by the system.

One of the items that you can add to the form questions is a label. A label item provides context or identifies the type of data that is expected to be recorded in a particular field. A label may or may not be associated with a variable depending on whether the data entered in the corresponding field in the EDC system or eDiary and eCOA apps needs to be recorded in the output dataset upon collection.

To add a label item to a 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, select the option to add a label item to the question in one of the following ways:

    • From the action bar, select Label icon_label.png.

      Selecting label item
      Figure 3. Selecting label item

    • From the action bar, select and drag Label icon_label.png to the needed question.

      Dragging label item to question
      Figure 4. Dragging label item to question

    • If there has been at least one item already assigned to the question, then next to any item, select More icon_more_actions.png > New Item icon_new_item.png.

      Adding label to existing item
      Figure 5. Adding label to existing item

  5. In the Add Item panel that expands, under the Generate tab, fill in the general details as explained in the following table.

    Adding label item
    Figure 6. Adding label item

    Tip

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

    Element

    Details

    Type*

    Select the Label type here.

    Caption*

    Enter a short title or description that defines the added item.

    Use Rich Text to format the caption text if needed.

    Rich Text

    Select rich_text_icon.png next to Caption or Help Text fields to open the text editor dialog and style your text as needed using the available formatting tools. The rich text you apply defines how your question text is displayed in the CRF when it is completed via EDC, eDiary, or eCOA.

    Question*

    Select the question to which the item is being added.

    If the Custom Question checkbox is selected, then you need to enter the question text manually.

    Custom Question

    Select this checkbox if you want to add a new custom question along with the created item to the form.

    If selected, it is required to enter a custom question text in the Question field.

    Show Caption

    Turn on this toggle to show the indicated caption next to the item on the form. Leave the toggle turned off to hide the caption text from the form.

    Text Align

    Select either the right or left alignment of the item on the form in relation to its question.

    Help Text

    Enter additional information, instructions, or clarification about the item, such as details on how to answer a corresponding question or what data is collected in the field.

    Use Rich Text to format the help text if needed.

    SAVE

    Select save_button_red_white.png to add the item to the question.

    CANCEL

    Select cancel_button_white_blue.png to cancel adding the item.

  6. In the same Add Item panel, go to the Definition tab to specify the variable definition for the item as explained in the following table.

    Specifying variable definition for item
    Figure 7. Specifying variable definition for item

    Important

    None of the fields in the following table are required since the label data is not mandatory for collection.

    Element

    Details

    Data Type

    Select the type of data that is to be collected for a corresponding question. The data type is usually preselected by the system but can be changed depending on the allowed data types for the selected CDASH variable.

    Length

    Enter the maximum number of characters or digits that the field can capture when entering data in EDC. The length is usually defined by the system according to the selected CDASH variable but can be updated.

    CDASH Variable

    Enter the name of the CDASH variable that is to capture data specified in a corresponding field in EDC. You can either select one of the available domain variables or enter a name for the custom one. The field only supports uppercase letters, numbers, and underscores.

    CDASH Label

    Enter the label for the CDASH variable that is to capture data entered in a corresponding field in EDC. The label is usually defined by the system according to the selected CDASH variable but can be updated.

    RecordID

    Enter the record number that enables different fields on the form associated with the same variable to capture data records in separate rows. These records will be presented accordingly in the output dataset upon data entry in EDC.

    For example, in the Vital Signs form, you have the questions Pulse, Temperature, and Respiratory Rate. The text item is assigned to all three questions and it is specified that the VSORRES variable is to capture the corresponding data.

    In order to distinguish the collected vital sign results in a more organized manner, you can assign record ID = 1 to the text item of the Pulse question, record ID = 2 to the text item of the Temperature question, and record ID = 3 to the text item of the Respiratory Rate question. In such a way, the captured results will be displayed in separate record rows in the output dataset.

    Moreover, you can enter record IDs separated by commas if you want the specific data point to repeat in the output dataset. For example, you can specify record ID = 1,2,3 for the label item Predose assigned to the Time Point question in the same Vital Signs form. This item is associated with the VSTPT variable which means that the Predose label will be displayed in 1, 2, and 3 record rows along with the pulse, temperature, and respiratory rate vital sign results.

    SAVE

    Select save_button_red_white.png to add the item with the specified variable definition to the question.

    CANCEL

    Select cancel_button_white_blue.png to cancel adding the item.

Once saved, the label item is added to the form question. 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.

An individual piece of data collected within a domain. It represents a specific attribute or characteristic that can vary among subjects in a study. Each variable is defined by its format (such as categorical, continuous, and so on) and plays a crucial role in data analysis, allowing researchers to assess relationships and outcomes in the study.

For instance, within the "Demographics" domain, variables might include "Age," "Gender," and "Ethnicity."

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.