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.

Prerequisites

Required Permissions

Users with the standard CDMS Study Designer study role can perform the actions described below by default. If your organization uses custom Study Roles, your role must grant the following permissions:

Type Permission Label Controls
Standard Tab Studio Tab

Ability to access the Studio tab
Functional Permission Design Study

Ability to create study design definitions and a study schedule from Studio

If your Study contains restricted data, you must have the Restricted Data Access permission to view it.

Learn more about Study Roles.

Create a Repeating Event Group

To create a repeating Event Group:

  1. Navigate to Studio > Event Groups.
  2. Click + New Event 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 whitespace with underscores.
  5. Click Create. Vault creates a new Event Group Definition record.
  6. From the Properties panel, select the Repeating checkbox.
  7. Optional: Enter a Repeat Maximum. This number indicates the allowed number of Event Group sequences in a single Casebook.
  8. 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.
  9. 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.

Don’t mark Log-type Event Groups as Repeating. This causes an error during publishing validation, and you won’t be able to deploy the study design.

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.

Custom Labels

To configure custom labels:

  1. Navigate to your repeating Event Group in Studio. Note that you must save and reopen the Properties panel after selecting the Repeating checkbox.
  2. Click into the repeating Event Group row to open the Properties panel..
  3. Click Repeating Event Overrides (Labels, Windows).
  4. Enter a Default Display (custom label) for each sequence of your Event Group.
  5. To override any Event Window configuration, use the Offset Type, Offset Event, Offset Days, Day Range Early, Day Range Late for each sequence of your Event Group.
  6. 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.