Configuring Cycles (Repeating Event Groups)
Vault EDC supports repeating Event Groups, which you can use to implement cycles in your study design. Each new repeating Event Group is a sequence. Data entry users can create new sequences of a repeating Event Group (up to a configured Repeat Maximum) and enter data in the contained Forms.
Create a Repeating Event Group
To create a repeating Event Group:
- Navigate to Studio > Event Groups.
- Click + New Event Group.
- Enter a Label.
- Optional: Update the Name. Vault automatically generates the Name from your entered Label by converting it to lowercase and replacing whitespace with underscores.
- Click Create. Vault creates a new Event Group Definition record.
- From the Properties panel, select the Repeating checkbox.
- Optional: Enter a Repeat Maximum. This number indicates the allowed number of Event Group sequences in a single Casebook.
- Your Event Group is now a repeating Event Group. You can now add it to your schedule and add its Events and Forms from Studio’s Design view.
- Before publishing your study, you must create at least one Add Schedule-type rule to add the first repeating Event Group sequence to a Casebook. Data entry users will be able to add subsequent event groups manually.
Prefix Label in Related Events
By default, the Prefix Label in Related Events checkbox is already selected. When this property is selected, Vault prefixes the Display Label of each Event in the group with the Display Label of the repeating Event Group. For example, Cycle (1) - Visit 1, Cycle (1) Visit 2, Cycle (2) - Visit 1, et al.
You can also configure custom labels for each sequence of your Event Group. With custom labels, Vault displays the custom label with the Event appended, instead of repeating the same label for each sequence.
To configure custom labels:
- Navigate to your repeating Event Group in Studio. Note that if you must save and reopen the Properties panel after selecting the Repeating checkbox.
- Click into the repeating Event Group row.
- In the Properties panel, click Edit.
- Click Custom Labels.
- Enter a label for each sequence of your Event Group.
- Click Save.
For each sequence of your Event Group, Vault now uses the Custom Label, instead of the event group’s Display Label.
Example Design: Treatment Cycles
If your study design includes cycles, especially cycles with a flexible number of repetitions, repeating Event Groups can save you a great deal of time and configuration. For example, your study needs to include a treatment cycle that subjects may participate in 3 to 6 times. Because there can be variation in the number of total cycles from subject to subject, using standard Event Groups to represent these cycles would likely cause confusion amongst data entry users, as well as a large amount of duplicate work for clinical programmers.
Create a repeating Event Group for your cycle. Set the Repeat Maximum to 6, as you know that there should be no more than 6 treatment cycles per subject. Data entry users may create anywhere from 0 to 6 sequences of this Event Group, but Vault prevents them from creating any more than that. Set the Display Label to “Treatment Cycle”. Add 3 Events to the Event Group: Day 1, Day 8, and Day 15. In the Day 1 event, the subject receives treatment, with follow up visits in the Day 8 and Day 15 events. Each of those Events should contain a set of data collection Forms. Lastly, create an Add Schedule-type rule to add the first sequence of the repeating Event Group to the casebook schedule.
What Data Entry Users See
Data entry users (investigators and CRAs) only see the first sequence your repeating Event Group upon new Casebook creation (or when Vault adds the Event Group to the schedule based on an Add Schedule-type rule). If your study design includes a repeating Event Group, users will see that Event Group listed as an available one when adding an Event to the Casebook. If you selected the Prefix Label in Related Events checkbox for this Event Group, then the data entry user sees the event group’s Name and sequence number, or a custom label, prefixed to the event’s Name.
As data entry users continue adding repeating Event Group sequences to a Casebook, they will see those Event Groups display as they do regular, non-repeating Event Groups.
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.
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 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.
Users with the Vault Owner security profile are automatically able to perform the actions described above. If your vault uses custom security profiles, you must have the following permissions:
|Security Profile||Tabs: Studio||Ability to access the Studio tab.|
|Security Profile||Objects: Event Group Definition: Create, Edit||Ability to create and edit Event Group Definition records.|
|Security Profile||Objects: Rule Definition: Create, Edit||Ability to create and edit Rule Definition records.|