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 The standard events eCOA Activated, Study Withdrawn, and Study Complete are included in every collection and cannot be edited or deleted.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

• eCOA Activated: The date is automatically 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• Study Withdrawn: When the site staff member populates a date for this event and the date occurs, the participant’s status updates to Study Withdrawn.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.

In addition to standard events, you can configure the following event types:

• Scheduled Events: These events are scheduled in sequence. The following capabilities can also be configured:
  • Events that anchor other events to trigger actions or display protocol expected dates or windows to site users.
  • Events that apply only to specific participant groups.
  • Events that require site users to assign participants to groups after the study begins.
• Unscheduled Events: These ad hoc events allow site users to add an event to individual participants when needed. Unscheduled events can be configured to apply only to specific participant groups.
• Criteria Checks: These checks can be run on demand by site users, and the results can be included in reports.

Accessing 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 New Events

Creating New Scheduled Events

To create a new Scheduled Event, complete the following steps:

1. Select Add Event and select Scheduled Event.
2. Enter an Event Label. This event label is displayed to site users in Veeva eCOA.
3. Enter an Event Name. You will use this value to refer to events in other parts of the collection, such as schedules or rules. See Configuring Schedules and Notifications for more information.
4. 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.
5. (Optional) 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.
6. (Optional) 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.
7. (Optional) If the collection has groups, the Applicable Groups list is available. By default, All is selected to apply the event to all participants. If this event should only apply to a subset of participants, select a subset of groups from the Applicable 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.
8. If you want to require site users to assign a participant to a group when the event occurs instead of when they create the participant, turn on Enable Event-Triggered Group Assignment and select one or more group types.
9. Select Save.

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

Creating a New Unscheduled Event

Complete the following steps to create an event that is available for a site to add to participants when applicable:

1. Select Add Event, and select Unscheduled Event.
2. Enter an Event Label. This label is displayed to site users in Veeva eCOA. A numeric identifier will be added to the label to distinguish between multiple submissions.
3. Enter an Event Name. You can use this value to refer to events in other parts of the collection, such as schedules or rules.
4. (Optional) If the collection has groups, the Applicable Groups list is available. By default, All is selected to apply the event to all participants. If this event should only apply to a subset of participants, select a subset of groups from the Applicable Groups list.
   • Applying 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.
5. Select Save.

Creating a New Criteria Check

Criteria Check events must be created before you can use them with rules. See Creating a Criteria Check Rule Template for more information.

1. Select Add Event, and select Criteria Check.
2. Enter an Event Label. This label is displayed to site users in Veeva eCOA.
3. Enter an Event Name. You will use this value to refer to events in other parts of the collection, such as schedules or rules. See Configuring Schedules and Notifications for more information.
4. 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.
5. Select Save.

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 applicable 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 Applicable 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 Applicable Groups include 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.

Inactivating 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.

Activating 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.