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 whose sponsors are using Veeva ePRO in Clinical Operations.

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 or to site staff.

Some study designs use a predictive schedule, which allows SiteVault to predict the expected event schedule based on an initial event date and time. SiteVault will populate the datetime fields for upcoming events once the initial date is selected. If the actual events do not follow the predicted schedule, the fields remain editable for you to update.

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 Surveys on the left menu.
2. Select the Participants tab.
3. On the Participants page, select the participant beneath the Patient Name column.
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 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 adjust an expected schedule 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 Surveys on the left menu.
2. Select the Participants tab.
3. On the Participants page, select the participant beneath the Patient Name column.
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 surveys and schedules made available to the participant or site staff 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 Surveys on the left menu.
2. Select the Participants tab.
3. On the Participants page, select the participant beneath the Patient Name column.
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.

Removing the actual event date and time for the participant’s event may modify the surveys and schedules made available to the participant or site staff based on your sponsor’s study design.

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Enabling and Disabling ePRO for a Participant

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