Contents

Introduction

An event (or a visit) represents a package of eCRFs that contain data that relate to a specific visit.

E.g. This normally represents a visit from a patient to a physician or a phone call with the patient. For example, at day 8 of a cycle lab work has to be done or every 8 weeks there's a survival phone call.

An EventGroup is a collection of events in a certain sequence from a start date up to an end date of that group of events (the visit dates of the individual events fall within start and stop of the EventGroup).

E.g. For a treatment cycle the protocol defines a visit at day 1, day 8 and day 15. The EventGroup is 'cycle' and the events are 'day 1', 'day 8' and 'day 15'; the visit date of day 1 would normally be the start date of the EventGroup and the visit date of day 15 cannot be after the end date of the EventGroup.

An epoch is a planned period of study participation (cfr. CDISC standards).

E.g. screening, treatment or follow-up.

Depending on the study specific settings, study specific events can be available by default in the data section or can be dynamically triggered by the subject specific activities initiated in the study flow.

Overview

The overview of events/EventGroups shows 3 types.

Type

Type	Description
Scheduled	The event was planned as described in the protocol. Scheduled events correspond to sets of forms that are expected to be collected for each subject as part of the planned visit sequence for the study.
Unscheduled	The event was not planned according to the protocol. Unscheduled events are available to report data that may or may not occur for any particular subject. A set of forms that are completed for an extra lab assessment (for example due to observed toxicity) which is not expected by the protocol. Or a lab assessment that is normally scheduled per protocol, but was done clearly outside protocol windows.
Common	The event is described in the protocol, but there is no specific visit in which it is planned. It is a randomly occurring event. An adverse event or a concomitant medications log.

Dates

Visit Date

For an event, a visit date can be requested. When a visit date is collected, the date is displayed in the events overview.

Start and End Date

Besides a visit date of events, a start and end date can be collected for EventGroups. The visits part of this EventGroup would then have visit dates between the start and end date of the group.

Event(Group) Validation Status

	Status	Description
Before submission	Missing	All mandatory forms within the event are missing.
	Optional	All mandatory forms within the event are missing.
	Incomplete	At least one form has some data completed but not submitted.
After submission	Issues	All forms within the event are submitted, but a form still has outstanding issues.
After submission	No issues	All forms within the event are submitted and none of the forms have outstanding issues.

Options

Several options are available at event(group) level.

Audit trail

The user can access the audit trail via thebutton. The audit trail will display all actions up to that specific level. It will thus show the audit trail of all actions on the questions or values and forms within that event, or values, forms and events within that EventGroup.

Comment

The comment button will display the number of comments already added on that specific level. Comments can be created by all users with management rights on the eCRFs, meaning that for most CRFs this would be both the site and sponsor.

Clear Data

A user can opt to clear all data from the entire event (if all data contained in that event belongs to that specific user) using the clear button . When clearing event data, a reason has to be provided.

After this confirmation, the user will receive a warning that this action will delete all forms within the event and ask for a second confirmation.

In case the event is dynamically triggered by the activity initiated in the study flow, a navigation button is available for the user to easily access the corresponding activity in the study flow section. Like that, the user can verify if sufficient data is completed to initiate the next activity in the subject specific pathway.

The activity details will indicate the status of the eCRF completion of the corresponding event.

Browser not supported