Capturing Data

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.

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.

• 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:

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, 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:

1. Select the edit icon next to the event date.
2. Add a New Datetime or select the remove icon (X) to remove the event date.

3. Enter a Reason for Change.
4. 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 are never removed during updates. In progress surveys are not rescheduled. This includes all parts of multi-part or composite surveys with one or more parts that are in-progress.

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.

1. Select the Add Unscheduled Event icon ().
2. Select the event you want to add, and select Next.
3. Enter the date of the event, and select Next.
4. Select which surveys you want to be included with the event, and select Create Event.

Surveys you do not select will be marked as Intentionally Left Blank. If you later determine that you need to complete them at the event, you can reinstate them. See Reinstating a Blank Survey for more information.

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 no surveys have been started, completed, or missed, you can remove an unscheduled event.

1. View the event you want to remove, and select Remove Event.
2. 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

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.

Moving a Completed Survey to a Different Event

If a survey was completed for the wrong event, you can move it to the correct event. Complete the following steps to move the survey:

1. View the survey you need to move.
2. Select the More Actions icon at the top of the page, and select Move Survey. The Move Survey popup box opens.
3. Select the destination event. You can only select events that have already happened or are currently available.
4. Enter a Reason for Change, and select Move Survey. A confirmation box opens.
5. Select Continue. The survey is moved to the selected event.
6. Select Close.

If the destination event has a scheduled survey of the same type that has not been started, the unstarted survey will be canceled.

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.