Managing Participant Event Dates and Times

Manage event dates and times for participants in Study Connect.

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Note Veeva ePRO is only available to sites conducting a study whose sponsor is utilizing Veeva ePRO in a Clinical Vault.

You can enter and update the actual dates and times for a participant’s study events (for example, First Dose Datetime) on the participant’s record. Based on your sponsor’s design for the study, one or more surveys and schedules may be related to the participant event on a participant’s record. You must enter the actual dates and times for those participant events in order for those surveys and schedules to be made available to the participant.

Entering Participant Event Dates and Times

After enabling ePRO for a participant, you must enter their actual event dates and times to begin their ePRO surveys and schedules. You can enter past and future dates and times.

To enter an actual event date and time for a participant, complete the following steps:

1. In Study Connect, select ePRO on the left menu.
2. Select the Participants tab.
3. On the Participants page, select the participant beneath the Patient Name column. The participant’s page opens.
4. On the participant’s page, expand the Participant Events section and locate the event.
5. Select the field beneath the Actual Datetime column and select a date and time.
6. Select Save.

The actual event date and time you enter for the participant’s event may begin or end ePRO surveys and schedules based on your sponsor’s study design.

Updating Participant Event Dates and Times

You can update actual event dates and times for participants to make changes to their event dates and times or to correct mistakes made during initial date and time entry.

To update an actual event date and time for a participant, complete the following steps:

1. In Study Connect, select ePRO on the left menu.
2. Select the Participants tab.
3. On the Participants page, select the participant beneath the Patient Name column. The participant’s page opens.
4. On the participant’s page, expand the Participant Events section and locate the event.
5. Select the Edit Participant Event icon () and update the date and time.
6. In the Enter Reason for Change pop-up, enter a reason for the updated date and time.
7. Select Save.

The actual event date and time you enter for the participant’s event may modify the ePRO surveys and schedules made available to the participant based on your sponsor’s study design.

Removing Participant Event Dates and Times

You can remove actual event dates and times for participants if the date and time was entered in error.

To remove an actual event date and time for a participant, complete the following steps:

1. In Study Connect, select ePRO on the left menu.
2. Select the Participants tab.
3. On the Participants page, select the participant beneath the Patient Name column. The participant’s page opens.
4. On the participant’s page, expand the Participant Events section and locate the event.
5. Select the Edit Participant Event icon () and select Clear.
6. In the Enter Reason for Change pop-up, enter a reason for removing the date and time.
7. Select Save.

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Enabling and Disabling ePRO for a Participant

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