The eCOA events reflect the protocol’s schedule and are used to schedule required surveys.
Viewing a Participant’s Events
The events are displayed on the participant’s page. You can select an event to view its details.
Relevant surveys are displayed by default. To change the view, select one of the following options from the Display Surveys list:
- All
- Available in Clinic
- Past
The events are displayed in the following order:
- The eCOA Activated event is always displayed at the top of the list.
- Any events with datetimes set in the past or today are sorted in chronological order.
- Any events with datetimes set in the future or without an entered datetime are sorted by their Sequence number.
Adding Event Dates
Event dates and times can be added in several ways, based on the sponsor’s study design. The event date and time may begin or end the availability of surveys.
- Manually Added: A Site User must enter a date and time for the event.
Note Entering an event datetime may trigger surveys that are already missed when they are created if they would have occurred in the past.
- API-Populated: The event’s date is populated by data sent using APIs. Site users will not have the ability to directly enter or edit the Event datetime.
- Rule-Populated: The event’s date is populated based on data collected in surveys.
A banner is displayed for API- and Rule-Populated to warn you that the date will be populated automatically. You can select Enter Date to manually add a date, but once the event criteria are met or the API date is received, the date will be changed and you cannot change it again.
Conditional event dates can also be configured to only become available if certain conditions are met. If these conditions are not met, the events are displayed in the Not Yet Available section. You cannot add a date for them or change their status.
Complete the following steps to add an event date:
- On the participant’s page, select the event.
- Enter or select the date and time that the event has occured or will occur on. Event dates can be past, current, or future, but cannot be set more than one year in the past from the current date.
- The sponsor may provide additional context for what date should be populated, such as a Visit Window or Protocol Expected Date. If an Expected Date is displayed, you can select Apply to use that date.
The page is updated with any surveys that are associated with the event, based on the date and time. If you assigned the participant to a group before entering the event date and time, the system may take a little longer to process and load surveys.
Marking an Event as Did Not Occur
If a participant was unable to attend a scheduled visit and no related surveys were missed, completed, or intentionally left blank, you can mark the scheduled event as Did Not Occur. This action lets the patient continue with the study schedule.
To mark an event as Did Not Occur, select the more options menu (
) next to the event and then select Did Not Occur.
Updating and Removing Event Dates
Complete the following steps to edit an event date:
- Select the edit icon
next to the event date. - Add a New Datetime or select the remove icon (X) to remove the event date.
Tip Select Learn How This Affects Survey Status to see how the existing survey’s schedules will change. Only survey statuses that are currently displayed on the filtered list are displayed in the descriptions. Close the Event Datetime Update window and change the Event page filter to view how surveys with other statuses may be affected.
- Enter a Reason for Change.
- Select Confirm.
The page is updated with the correct surveys for the new date and time. When an event datetime is updated, previously missed surveys may be removed and replaced with new surveys to align with the new date and time. Completed surveys will never be removed when an event datetime is updated.
Adding an Unscheduled Event
If the sponsor has configured unscheduled events, participants may need to be added when additional ePRO or eClinRo surveys should be collected based on the participant’s trial experience.
- Select the Add Unscheduled Event icon (
). - Select the event you want to add, and select Next.
- Enter the date of the event, and select Next.
- Select which surveys you want to be included with the event, and select Create Event.
The event is added for the participant, and all relevant surveys are assigned.
Removing an Unscheduled Event
If you determine that an unscheduled event is no longer relevant to the participant’s experience in the trial and they have not started, completed, or missed any related surveys, you can add an unscheduled event.
- View the event you want to remove, and select Remove Event.
- Add a Reason for Change and select Remove.
The event and all related surveys are removed from the participant.
Running a Check Event
Check events are actions that evaluate survey data and output a result. They are available for site users based on the sponsor’s study design. To run a check, open the event and select Start Check.
The results are displayed and saved in the Check view. If no information is displayed, it may mean that some information required to run it is missing or hasn’t yet been added. Contact the study sponsor if you have questions. The check will also not display restricted data to users who do not have permission to view it.
To run the event again, select Run Again. The latest results are displayed at the top of the view.
Deleting Events
Note You cannot delete an event if it has been included in an approved collection. To make it unavailable, Veeva recommends removing all references to event from surveys, rules, trigger references, and so on, and then changing the event title to indicate that it has been deleted.
Complete the following steps to delete an event that has not been included in an approved collection:
- On the participant’s page, select the event.
- Select the delete icon.
Withdrawing or Ending Study Participation for a Participant
When the participant withdraws from the trial or completes their trial participation, enter a date and time for the Study Complete or Study Withdrawn event. The system will use the date and time to deactivate the participant record or prompt you to deactivate it when ready. Deactivating a participant will end data collection and stop surveys and notifications from being sent to them. See Deactivating and Activating a Participant for more information.
