Basic Calendaring

Each Event Card in Study Designer includes a Calendar section to automate event scheduling and closing rules and a Notifications section to automate sending notifications. You can define:

• When an Event should be scheduled relative to other Events.
• When an Event should automatically close if not completed.
• Notifications to be sent to participants or study personnel.

Schedule Event Creation

When scheduling an event, the following options are available:

1. Upon participant creation: schedules the event automatically when a participant is added.
2. Close [event] if not completed within X day(s): closes the event if it becomes overdue.
3. Occurs [X] day(s) after [another event]
4. Create [this event] when another event reaches [Status]
5. Schedule [this event] [X] days before its date

Event limitations:

• First Event: Only the first two options (upon participant creation and close if not completed) are available.
• Second and Subsequent Events: All other options apply to the second and subsequent events.

ℹ️ Note: This ensures that participants are automatically scheduled for the first event, while full scheduling flexibility applies to all later events.

Choose When to Schedule Events

You can define when an Event should be scheduled and automatically closed using the following options:

Scheduling Options

• Upon participant creation: schedules the Event automatically when a Participant is added. (Applies only to the first Event.)
• Occurs [x] day(s) after [Triggering Event]: Schedules this Event a specific number of days after the selected triggering Event. The triggering Event populates once chosen from the top dropdown, and you must specify whether the scheduling is based on the Event’s status or start date.
• Create [this Event] event record when:The following can be selected:
  • [Triggering Event] has reached [status]: Schedules the Event when the triggering Event reaches Scheduled, Data Entry Started, or Completed.
  • [x] day(s) prior to Event date: Schedules this Event a set number of days before its date.
• ℹ️ Note: “this Event” refers to the selected Event being scheduled.

Auto-Close Events

• Close [this Event] Event if not completed within [x] day(s) of Event date: Once scheduled (manually or automatically), the Event can be automatically closed if not completed within the defined timeframe.

If an Event has existed for [x] number of days, Calendaring will update its status as follows:

• If the event is about to complete, it moves to Complete.
• If data entry has started but the event is not about to complete, it moves to Stopped.
• If the event is not started, it moves to Skipped.

ℹ️ Note: These status changes are reversible; you can manually change them back.

After configuring the schedule, click Create to apply the rules.

ℹ️ Note: Only one scheduling rule and one auto-close rule can be configured for each Event. Each rule can apply to different times or recipients.

Reordering Events

If you reorder Events:

• Extended options applied to later Events are preserved.
• Moving an Event to the first position displays only limited options.
• If moved back, the saved extended options are restored.

⚠️ Always review Calendar after reordering Events to ensure it reflects your intended schedule.

Calendar Notifications

The Notifications section within each Event Card allows you to send automated Email or SMS messages related to the Event. Notifications can be scheduled to send to one or more static email addresses or to the Participant.

• Notifications can be triggered upon Event creation, at specific time intervals, or upon completion.
• You can configure multiple notification rules for a single event (e.g., at different times or to different recipients)

⚠️Using Calendaring notifications alongside the legacy OC4 rules within the same study is not supported.

Notification Rule Components

Each notification rule includes timing, recipients, and message content, as described below:
When: The timing for the notification to be sent

• Upon creation of this Event: Notification will be sent as soon as the Event has been created.
• Before this Event: Notification will be sent [x] days prior to the Event date at the time designated (based on the Participant's Site's time zone).

• After this Event: Notification will be sent [x] days after the Event date at the time designated (based on the Participant's Site's time zone).

• This Event is complete: Notification will be sent as soon as the Event has been completed.

To: Notifications can be sent to:

• A single email address or multiple comma-separated email addresses.
• ${participant}: When the Participate module is activated, OpenClinica sends the notification to the contact information entered for the Participant. If the Participant has both an email address and a phone number, they will receive the notification by email and text message.

Subject: The subject is used as the subject for email notifications only, and can be customized using variables.

Message: Enter the email or text message body. The message can be customized using variables.

Supported Variables

Variables refer to specific study data and can be inserted into Subject and Message to customize the message.