Working with Repeating & Common Forms
Repeating forms allow answers to the same set of questions to be captured multiple times. Common forms are forms not associated with a single event, instead spanning across all study events. For example, the Concomitant Medication form may be a common form.
Repeating forms are forms that you can use multiple times during a study. These forms allow users to capture data for the same set of questions multiple times during a single event or study. Vault displays repeating forms on the casebook schedule. If there is more than one repeating form completed in a casebook, the casebook schedule displays the form name with a count of forms. Repeating forms are associated with a study event. To view repeating forms, navigate to that form using either the breadcrumb menu or the form carousel.
Common forms are forms that span across study events, such as a Concomitant Medication or Adverse Event form. Common forms are associated to the casebook, rather than an event. Vault displays common forms in the casebook schedule, the breadcrumb menu, and the form carousel. An External Link badge (see below) indicates a common form in the form carousel. Clicking a common form from the form carousel or the breadcrumb menu displays a table view of existing forms.
Viewing Repeating & Common Forms
Once you have created repeating or common forms, you can return to them through the form carousel, the breadcrumb menu, or the casebook schedule.
Repeating Forms display a count of form sequences in the form carousel. In the image below, there is one (1) AE form sequence in the subject Casebook. There are zero (0) Concomitant Medication form sequences.
Repeating and common forms display in a table view. The table includes all forms of that type, for example, all concomitant medication forms associated with a subject. When viewing all of your repeating forms in table view, Vault displays a column for each repeating item group in that form.
You can expand or collapse the Common Forms panel under the schedule tree using the More or Less buttons.
In the Form Panel, each row has a Click for details link in the Item Group’s column that opens that Item Group in the form viewer.
After you click to view a single repeating or common form, you can view other forms of that repeating or common form by clicking the left and right arrows next to the form name.
Adding a Repeating or Common Form
You can add a repeating or common form from the casebook. Note that your study’s design may limit the number of times a form can repeat.
- From the table view, click +New.
- Vault adds the new form to the subject’s casebook and opens the form in edit mode. To return to the repeating or common form table view, click the form name in the form carousel. You can return to the form later using the form carousel or the breadcrumb menu.
- Enter data in the form.
- Click Complete.
If your Study has recently undergone an amendment, note that Vault automatically creates your new Form using the most recently assigned casebook version.
In the Data Entry tab, you can link related forms through Form Linking. For example, one or more Concomitant Medication forms can be linked to an Adverse Event or Medical History form in order to group similar or related data or indicate cause and effect. If your Study has Form Linking configured, the linked form displays in the Data Entry tab as a toggle option, from which you can view, add, and edit linked forms.
To add Form Links:
- Navigate to the Form Link object via the toggle menu.
- Click + Add Link.
- Select one or more forms to add and click Save.
Once you’ve created Form Links, you can edit the links via the Edit Links button. Editing links allows you to select or deselect forms to display in your Form Label tab. Forms can also be filtered by Event through the Edit Links button.
To remove a Form Link:
- Click the actions menu to the right of the Edit Links button.
- Click Remove All Links.
- To remove individual links, hover your cursor over the Reference # box to the left of the Event name and click on the Actions menu. Select Remove Link.
Accessing the Form Link Audit Trail
To view a history of when links were created or removed, you can access the Form Link Audit Trail from the Actions menu.
Repeating Item Groups
In addition to repeating forms, your study may also include repeating item groups, which allow you to answer the same set of questions multiple times on a given form. For example, your study may use a repeating item group for a physical exam. Repeating item groups can be used in both repeating and standard forms.
When viewing a repeating item group in a form, you can click + New Section to create a new item group. Vault then creates the new item group and its associated items.
Some study designs may include a Form with an automatically created, default number of repeating Item Groups. For example, a Physical Exam form may include five Item Groups by default, one for each body system included in the exam.
Viewing Repeating Item Groups
How repeating Item Groups display in View mode depends on your study design. All repeating Item Groups display the same in Edit mode.
This Physical Exam repeating Item Group is in tabular view. You can click +New to add Item Groups when in tabular view.
Vault displays the appropriate query status icon for Item-level queries in the item’s table cell in tabular view. You can click the query status icon to open the query in the Query dialog, where you can answer the query. Note that users can’t edit data, create queries, or perform SDV or DMR from tabular view.
This Physical Exam repeating Item Group is in form view. When in form view, click +New Section to add an Item Group.
Adding a Repeating Item Group (Section)
You can add a new sequence of a repeating Item Group from within the Form containing it. Note that your study’s design may limit the number of times an item group can repeat.
- Navigate to the form containing your repeating Item Group.
- If sequences already exist, scroll past the last existing sequence. Depending on your study’s design, Vault may automatically create all required Item Groups for a Form. For example, for a Physical Exam form, Vault may add an Item Group for each body system examined.
Click + New Section.
- Vault adds a new sequence of the Item Group to the Form.
- Enter data in the Item Group.
- Click Complete when finished entering data for the entire Form.
If your Item Group uses tabular view, click +New in that view to add a new Item Group.
If your Study has recently undergone an amendment, note that Vault automatically creates your new Item Group using the most recently assigned casebook version.
Which permissions control your access depends on when your vault was created. If your vault uses the Role by Study feature, see the first section, Role by Study Permissions. If your vault does not use the CDMS Role by Study feature, see the second section, Profile Permissions.
Role by Study Permissions
Users with the standard CDMS Principal Investigator, CDMS Sub Investigator, and CDMS Clinical Research Coordinator application roles can perform the actions described above by default. If your vault uses custom Application Roles, your role must have the following permissions:
|Standard Tab||Data Entry Tab||
Ability to access the Data Entry tab
|Functional Permission||Data Entry||
Ability to enter study execution data
If your Study contains restricted data, you must have the Restricted Data Access permission to view it.
Learn more about Study Roles.
These actions are available for the EDC Clinical Research Coordinator and EDC Investigator security profiles.