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 The standard events eCOA Activated, Study Withdrawn, and Study Complete are in every collection and cannot be edited or deleted. The standard events behave in the following way for site staff:

• eCOA Activated: The date is populated as soon as the site finishes creating the participant in Veeva eCOA.
• Study Withdrawn: When the site staff member populates a date for this event and the date occurs, the participant’s status updates to Study Withdrawn.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 Event.
2. Select the event type you are adding: Schedule Event or Criteria Check. See Creating a Criteria Check Rule Template for more information about Criteria Check events.
3. Enter an Event Label. This is the event label that is displayed to site users in Veeva eCOA.
4. Enter an Event Name. This is the value that you will use to refer to events in other parts of the collection, such as schedules or rules. See Configuring Schedules and Notifications for more information.
5. Enter a Sequence.
   • The sequence must be a whole numeric value.
   • Events cannot share the same sequence numbers.
   • The sequence number determines how events are displayed on this page and to site staff in Veeva eCOA.
6. If there are groups configured in the collection, the Related Groups field is available. By default, all events have 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.
7. For Schedule Events, complete the following steps to define a protocol expected date for this event in the Scheduling Options section:
   1. Enter an Anchor Event that occurs before the event you are adding.
   2. Enter the number of days after the Anchor Event that the event you are adding will occur in the Offset Days field.
   3. Enter a Default Event Time.
   4. Select whether you want the datetime to be Displayed for Sites or Populated for Sites.
      • If the datetime is Populated for Sites, events with protocol expected dates will be automatically scheduled when site users enter a date and time for the Anchor Event. If needed, the site can update the protocol expected date.
      • For example, A Follow-Up Visit has an Anchor Event of 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 after the Dosing Visit.
8. If you want to define a window of time the event should be available for, you can turn on the Event Window toggle and enter the number of Days Before and Days After the anchor event that this event can be scheduled for.
9. Select Save.

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

Editing an Event

To edit an existing event, complete the following steps:

1. In the row of the event you want to edit, select the Edit Event icon ().
2. Edit the information you want to change.
   • Events, Groups, and Schedules:
     • 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.
     • 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 ().
2. When the deletion confirmation appears, select Remove.

Inactivate an Event

To remove an event from site users in Veeva eCOA after the event has been in an approved collection, you can inactivate the event.

Complete the following steps to inactivate the event:

1. Find the event in the table and select the Inactivate icon ().
2. Select Inactivate.

Site users can still view the event in eCOA for participants where any data was collected. Previously collected data is included in reports. However, site users can no longer collect more data for the event for any participants.

Activate an Event

If you want to reactivate an event that you inactivated, complete the following steps:

1. Find the event in the table and select the Activate icon ().
2. Select Activate.

The event can now be referenced by schedules, criteria checks, or groups. The event will appear in eCOA for site users.