18.3.1 Events

Once users have created a study event, they can configure the event by accessing the Event Card. On the Event Card, users are able to update event name, description and properties, as well as set up automatic event scheduling and notifications.

Description / Properties

Clicking on the Event name will make the field editable. The user can update the Event name as needed, and Save. Updating the Event name will change the name of the event that appears within Study Runner.

This does not change the Event OID that was assigned at the time of Event creation.

Clicking on Edit under Description will allow the user to add or update the Event description as needed. This is optionally displayed on the Participant Dashboard for Participate and eConsent events.

There are two main types of events:

• Visit-Based: An event that is scheduled to occur within the study and is associated with a visit date. These visits are associated with a schedule that is outlined in the study protocol, and each visit has a specific set of forms that are collected.
• Common: An event that isn’t necessarily associated with a visit but may occur any time throughout the study, such as an Adverse Event. They can additionally be defined as:
  • Repeating: Used when the event needs to have multiple instances of the event, such as with an Adverse Event.
  • Non-Repeating: Used when the event will only occur once, such as Early Termination.

Calendar Configurations

Calendaring allows the user to define automated Event scheduling based on the status of other study Events.

Users can choose when to create and also when to close events:

• Occurs [x] day(s) after [Triggering Event]: Schedules this Event for a specific number of days after another study Event, which are shown in the dropdown menu.
  • Create [this Event] event record when:  Only one of the following can be selected:
    • [Triggering Event] has reached [status]: Schedules this Event when the Triggering Event has reached a specific status. The options are Scheduled, Data Entry Started, or Completed.
    • [x] day(s) prior to event date: Schedules this Event a specific number of days before the Event date.

• Close [this Event] event if not completed within [x] day(s) of event date: Once an Event is scheduled, whether automatically or manually, the user can elect to close it automatically if it has not been completed within [x] days.

Calendar Notifications

The user can also configure notifications to be sent upon Event status change. Notifications can be scheduled to send to one or more static email addresses or to the Participant.

Important Note: Using Calendaring notifications alongside the legacy OC4 rules within the same study is not supported.

• 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: Notification can be sent to one contact, or a comma-separated list of multiple contacts. The following types of contact information can be entered:
  • Email address
  • ${participant}: When the study has the Participate module activated, will send the notification to the contact information entered into OpenClinica for a Participant. This will send an email and a text message if the Participant has both an email address and a phone number.
• Subject: The subject is used as the subject for email notifications only, and can be customized using Variables.
• Message: The message can be customized using Variables.

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

Collaborate

Members

Shows the users involved in designing the study who can be associated with specific Events.

Labels

A Label is a color or color with text that can be used to represent groups of Events. Labels can be used to help facilitate building a study but have no functional implications. For example, a label can be added for events that require review.