Events

An Event is a group of Forms used in your Study. An Event may or may not correspond to a real-world visit. There are two main types of Events:

• Visit-Based Events
• Common Events

For information on Event Statuses and Attributes, refer to Status Icons.

Visit-Based Events

Most Events in a clinical trial are Visit-Based Events, such as Week 2, Week 6, or Monthly Follow-up.

• These visits are scheduled relative to the baseline (for example, Week 2 occurs two weeks after baseline, Week 6 occurs six weeks after baseline).
• The visit schedule is defined in the Study protocol.
• Each visit includes a specific set of Forms to be collected.

When you review the Visits section, the system automatically opens the earliest visit that is not complete. Incomplete visits display with a blue background.

A visit is considered complete when it has one of the following statuses: Complete, Skipped, Stopped, Removed, or Archived.

Common Events

Some Events are not tied to a visit date and occur outside of the regular schedule. Examples include:

• Adverse Events (AEs)
• Concomitant Medications (ConMeds)
• Early Termination

Common Events are used to collect information independent of visit timing.

They can be configured as:

• Repeating Events – for data that may occur multiple times per Participant (e.g., AEs, ConMeds).
• Non-Repeating Events – for data that can occur only once per Participant (e.g., Early Termination).

ℹ️ Note: The form that was opened most recently is indicated by the yellow background.

Event Types and Icons

Icon	Event Type	Description	Example(s)
	Visit	An event that is associated with a visit date. The event can be repeating or non-repeating.	Week 2 Visit (non-repeating); Monthly Follow-Up for Disease-Free Survival (repeating)
	Common	An event that is not necessarily associated with a visit date.	Early Withdrawal or Termination (non-repeating); Adverse Events (repeating)
	Repeating	An event that repeats in your study, either a known or unknown, number of times. This icon will appear adjacent to one of the previous two when an event is a repeating event.	Concomitant Medications

Scheduling an Event

Once a Participant has been added, you can schedule Events.

You can schedule Events from:

• The Participant Matrix
• The Participant Details screen
• The Tasks menu

For more information, refer to Scheduling and Editing Events.