Add time 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 time item. If you need to capture the timing of specific events or activities, such as medication administration, vital sign measurements, or study visits, a time item can be assigned. It enables precise recording of the time during the data entry in the EDC system or eDiary and eCOA apps when these events take place.
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In the Study Designer application header, select the CRF DESIGN tab.
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In the toolbar, select the latest draft CRF version marked with the respective unlock symbol
, otherwise, you cannot perform any actions.
Figure 1. Selecting latest draft CRF version
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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.
Figure 2. Accessing form to configure
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On the form content page that appears, select the option to add a time item to the question in one of the following ways:
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From the action bar, select Time
.
Figure 3. Selecting time item
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From the action bar, select and drag Time
to the needed question.
Figure 4. Dragging time item to question
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If there has been at least one item already assigned to the question, then next to any item, select More
>
New Item 
.
Figure 5. Adding time to existing item
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In the Add Item panel that expands, under the Generate tab, fill in the general details as explained in the following table.
Figure 6. Adding time item
Tip
In the following table, mandatory elements are marked with an asterisk (*).
Element
Details
Type*
Select the Time type here.
Caption*
Enter a short title or description that defines the added item.
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.Format
Select the time format in which the data needs to be captured when entered in EDC. The default preselected time format is the one indicated in the Study Designer global settings.
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.
Auto-query for Required Field
Turn on this toggle if you want the field associated with the item to become required for data entry in the EDC system, and submitting the form with this field empty automatically triggers a system query. Leave the toggle turned off if this field can be optional for data entry.
Missing data affects form status
Turn on this toggle if you want the CRF to have the Incomplete status in the EDC system when the data has not been entered in the field associated with the item. Leave the toggle turned off if you do not want this field's status to affect the status of the CRF upon submission.
This toggle becomes available only if the Auto-query for Required Field toggle has been turned on.Require SDV
Select this checkbox to set the source data verification (SDV) stage as mandatory for this data item.
Requires Manual Reviews
Select the checkbox next to the needed review stage to set it as mandatory for this data item. The available options are DM Review for the data manager review, CRA Review for the clinical research associate review, and Safety Review for the safety team review.
Restrict Manual Entry
Turn this toggle on if you want to prevent manual data entry to the field for all users except for those for whom restricted data editing is allowed in EDC. Leave the toggle turned off if you do not need to arrange specific data entry restrictions for this element.
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.
Rich Text
Select
next to the Help Text field 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.SAVE
Select
to add the item to the question.This button is available only if the variable definition for the item has been specified.CANCEL
Select
to cancel adding the item. -
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.
Figure 7. Specifying variable definition for time item
Important
All fields in the following table are required and marked with an asterisk (*) because the time item must be associated with the variable that captures the data entered in EDC.
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.
SAVE
Select
to add the item with the specified variable definition to the question.CANCEL
Select
to cancel adding the item.
Once saved, the time item is added to the form question. You can now continue to maintain forms with available actions.