Managing Events

You can create and manage study events to designate the visits and study milestones at which surveys are assigned to respondents. The standard events ePRO Activated, Study Withdrawn, and Study Complete are in every collection and can’t be edited or deleted. The standard events are behave in the following way for site staff:

  • ePRO Assigned: The date is populated as soon as the site finishes creating the participant in Veeva ePRO.
  • Study Withdrawn: When the site staff member populates a date for this event and the date occurs, the participant’s status updates to Study Withdrawn.
  • Study Complete: When the site staff member populates a date for this event and the date occurs, the participant’s status updates to Study Complete.

Access a Collection’s Study Events

To view and manage study events in a collection in Studio, open the collection and select the Events tab.

Creating a New Event

To create a new event, complete the following steps:

  1. Select Add Events.
  2. Enter an Event Name and Sequence.
    • The sequence must be a whole numeric value.
    • Events can’t share the same sequence numbers.
    • The sequence number determines how events are displayed on this page and to site staff in Veeva ePRO.
  3. By default, the new event is created with Related Groups set to All Groups so that the event applies for all participants. If this event should only apply for a subset of participants, you can select a subset of groups from the Related Groups list.
    • Relating events to groups of different group types:
      • If the event is related to a subset of groups in different group types, then a participant must be in both groups to receive this event.
      • Example: An event is related to the “Age Range” group “5 to 10 years of age” and the “Cohort” group “Cohort A”. For a participant to receive this event, they must be in the “5 to 10 years of age” and “Cohort A” groups.
  4. You can define a protocol expected date for this event using the Anchor Event and Offset Days fields. Consider the following information as you add this value:
    • The selected Anchor Event should occur before the event you’re adding. The Offset Days field defines how many days after the Anchor Event the event you’re adding will occur.
    • During a study, events with protocol expected dates will be automatically scheduled when the Anchor Event occurs.
    • Example: The Follow-Up Visit is anchored to Dosing Visit with an offset of 3 days. During a study, when the site enters a date and time for a participant’s Dosing Visit, the Follow-Up Visit is automatically scheduled for 3 days later. If needed, the site can update the schedule date.
  5. Select Save.

The new event is now ready to be used in a schedule.

Editing an Event

To edit an existing event, complete the following steps:

  1. Beside the name of the event you want to edit, select the Edit Event icon (Edit Event icon).
  2. Edit the Events, Groups, and Schedules information you want to change:
    1. The system validates that the event’s related groups are consistent with the groups on schedules that use the event. If a schedule uses this event as a Start Event or End Event and also applies to a subset of groups, the system will validate that the groups selected as Related Groups for the event include the groups related to the schedule.
    2. Example: Visit 1 is the Start Event for a schedule that only applies to Cohort A. The system will validate that Visit 1’s Related Groups includes Cohort A.
  3. Select Save.

Deleting an Event

To delete an existing event, complete the following steps:

  1. Beside the name of the event you want to delete, select the Delete Event icon (Delete Event icon).
  2. When the deletion confirmation appears, select Remove.