Capturing Data

Record study events and submit participant surveys

Working with Events

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

Adding Event Dates

The event date and time may begin or end the availability of surveys, based on the sponsor’s study design.

Complete the following steps to add an event date:

  1. On the participant’s page, select the event.
  2. Enter or select the date and time that the event has occured or will occur on. Event dates can be past, current, or future. The page is updated with any surveys that are associated with the event.
    • 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.

Updating Event Dates

If you need to edit an event date, select the edit icon {Edit button} next to the event date and update it. You can also remove the event date. The page is updated with the surveys that are associated with the event, based on the date and time.

Adding an Unscheduled Event

If the sponsor has configured unscheduled events, you can add them for participants when additional ePRO or eClinRo surveys should be collected based on the participant’s trial experience.

  • Select the Add Unscheduled Event icon ({Add Unscheduled Event button}).
  • 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:

  1. On the participant’s page, select the event.
  2. 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.

eCOA