Configuring Repeating Forms & Repeating Item Groups

Vault EDC supports repeating Forms and Item Groups, which you can use to collect the same set of data multiple times within a single Event. Each new repeating Form or Item Group is a sequence. Data entry users can create new sequences of repeating Forms and Item Groups (up to a configured Repeat Maximum) and enter data within.

Create a Repeating Form

To create a repeating Form:

1. Navigate to Studio > Forms.
2. Click + New Form.
3. Enter a Label.
4. Optional: Update the Name. Vault automatically generates the Name from your entered Label by converting it to lowercase and replacing whitespaces with underscores.
5. Click Create.
6. From the Properties Panel, select the Repeating checkbox.
7. Optional: Enter a Repeat Maximum. This number indicates the allowed number of form sequences in a single Casebook.
8. Optional: Configure any additional properties.
9. Click Save.
10. Your Form is now a repeating Form. You can now add it to your schedule and add its Item Groups and Items from Studio’s Design view.

Creating Common Log Forms

For a Form to appear as a common form in the casebook schedule, you must add it to an Event with the Log event type.

The form-level configuration for common log forms is the same as repeating Forms (see above).

Create a Repeating Item Group

To create a repeating Item Group:

1. Navigate to Studio > Item Groups.
2. Click + New Item Group.
3. Enter a Label.
4. Optional: Update the Name. Vault automatically generates the Name from your entered Label by converting it to lowercase and replacing whitespaces with underscores.
5. Click Create.
6. From the Properties Panel, select the Repeating checkbox.
7. Optional: Enter a Repeat Maximum. This number indicates the allowed number of item group sequences in a single Casebook.
8. Optional: Configure any additional properties.
9. Click Save.
10. Your Item Group is now a repeating Item Group. You can now add it to a Form and add its Items from Studio’s Design view.

Item Group Properties

The following configurations are available in the Properties panel for repeating Item Groups:

Display Formats for Repeating Item Groups

You can configure your repeating Item Group to use a Form or Grid layout. With form display format, Vault displays your repeating Item Group inline in the form. With grid display format, Vault displays your repeating Item Group in a tabular layout, similar to the layout for repeating Forms.

You can choose the Display Format property, either Form or Grid, when viewing your repeating Item Group in Studio’s Design view.

Setting Up Default Data on Item Groups

To set up default data for a repeating Item Group Definition:

1. Navigate to the repeating Item Group Definition you want to set up default data for in Studio.
2. Click into the record.
3. From the Properties panel, in the Default Data section, click Edit.

4. In the Default Data dialog, select up to two (2) Items to base the default number of Item Groups on. These must be Codelist-type Items that you have already added to this Item Group in Design view. Note that if you select two Items, Vault EDC creates an Item Group for each combination of the two Items (for example, if two Codelist-type Items have two values, Vault EDC would create four repeating Item Groups).

5. Click Select Values.
6. Select the Codelist Items for which Vault EDC will create an Item Group sequence for. If you chose two Items, Vault EDC automatically creates a row for each combination of Codelist Items. You can remove and reorder combinations before saving.
7. Optional: Reorder the Codelist Items by dragging and dropping.
8. Optional: Click Remove (x) to remove a Codelist Item from the default list.
9. Click Save.

If you chose more than one Item, Vault EDC creates one Item Group sequence per combination of Codelist Items. If you chose only one Item, Vault EDC creates an Item Group sequence for each Codelist Item.

To reset your default data configuration:

1. Navigate to the Item Group Definition whose default data you want to reset.
2. From the Properties panel, deselect the Repeating checkbox.
3. Click into another field or away from the Properties panel to prompt Vault to save your change.
4. Select the Repeating checkbox again. This resets the default data configuration for that item group. You can now use the steps above to set up default data.

Optional Considerations

The following configurations are not required for default data to function, but they may be useful for maintaining consistency across Forms with defaulted Item Groups.

• Set the Repeat Maximum property for your Item Group Definition to equal that of the number of Codelist Items you selected for default data.
• Set the Repeat Maximum property for your Item Group Definition to greater than the number of default combinations. If the Repeat Maximum is greater than the number of default combinations, users will be able to create new Item Group sequences, in addition to those Vault creates. This allows your users to collect a standard set of data Items, while still allowing users to collect and augment additional information.
• Set the Codelist-type Item you based your default data on as Read-Only.

Example Design: Medical History (Repeating Form)

For the Deetoza study, sites will collect information about a subject’s medical history during the Baseline Visit event. The sponsor wants each medical history event to be tracked as an individual Form. Lateef, a study designer for the Deetoza study, can easily accomplish this using a repeating Form for medical history.

This example design includes the following design definitions:

• Form: The Medical History form is a repeating Form for collecting data related to individual medical history events. This form has the Repeating checkbox selected and the default Repeat Maximum of 9999.
• Item Group: The Medical History item group contains all data collection Items for the Medical History form.
• Items: There are data collection Items for each data point required for medical history events.

For each subject, a data entry user can create as many sequences of the Medical History form as needed to capture all relevant medical history events for each Subject.

Example Design: Physical Exam (Repeating Item Group)

Linda is a study designer on the Wonderdrug study. She needs to create a way for data entry users to easily record data about a physical exam during the study’s Baseline Visit. The exam will cover six (6) different body areas, and the same data is required for each body area.

Instead of creating an Item Group for each body area’s exam, Linda can create a single repeating item group, Physical Exam, and configure default data to automatically create sequences for each body area.

This example design includes the following design definitions:

• Form: The Exam form definition contains the Physical Exam item group.
• Item Group: The Physical Exam item group is repeating, with one item group on the Exam form for each body system.
• Item: The read-only Body Area item controls the default data for the Physical Exam item group. Vault automatically adds a repeating Item Group sequence for each code within the Body Area codelist.
• Codelist: The Body Area codelist contains a code for each body area included in the physical exam.

For each subject Casebook, in the Exam form, Vault creates a repeating Physical Exam item group sequence for each body system.

What Data Entry Users See

The screenshots below show what repeating Form and Item Group configurations look like to data entry users (investigators, CRCs, etc.).

Repeating Form

Repeating forms display as regular forms in the casebook schedule. Each repeating form as a count of all existing form instances appended to the form Name.

Once a user clicks + New and adds a new Form, the data entry experience is the same as a non-repeating Form.

Common Form

Vault displays common forms on the casebook schedule in their own Common Forms panel.

Once a user clicks into a common form, they can see a tabular view of all existing forms. They can click + New to add a new form.

Repeating Item Groups

How repeating Item Groups display in View mode depends on their Display Format property. All repeating Item Groups display the same in Edit mode.

Grid Format (Tabular View)

This Physical Exam repeating Item Group is in grid format.

Form Format (Form View)

This Physical Exam repeating Item Group is in form format. It also uses default data.

With form format, users see a + New Section button to add instances of the repeating Item Group.

Study Update Restrictions

After you publish the initial version of your Casebook Definition, Vault prevents you from making certain changes in any later versions you may create. If you were to make these changes, it could cause errors during the casebook amendment process.

See Study Update Restrictions for a list of disallowed changes and available workarounds.

Related Permissions

Users with the standard Vault Owner or Design security profiles can perform the actions described above by default. If your vault uses custom security profiles, you must have the permissions described in the Profile Permissions table.