Introduction
An event (or a visit) represents a package of eCRFs that has to be be completed within the same time frame.
E.g. This normally represents a visit from a patient to a physician
An eventgroup represents several events that are considered as to occur in a defined period of time
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'.
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 |
| 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 concomitant medications log |
Category
Within these types, events and eventgroups are ordered according to category. The most obvious would be to group several events/eventgroups in an epoch. It is possible to hide the content of a category by collapsing it.
When a category is considered "clean" or "no Issues", the category is minimized by default. In case of missing, incomplete or data with issues the category remains as default always maximized.
Dates
Visit Date
Within 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
Within an eventgroup...
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 is NOT submitted and at least 1 form is NOT missing | |
| After submission | Issues | All forms within the event are submitted, but a form still has outstanding issues |
| No issues | All forms within the event are submitted and none of the forms has outstanding issues |
Options
Several options are available at event(group) level.
Audit trail
The user can access the audit trail via the 
icon. The audit trail will display all actions up to that specific level.
Comment
The comment icon will display the number of comments already added on that specific location. Comments can be created by all users with management rights on the eCRFs, meaning for regular a CRF this would be both the site and the sponsor.
- Query on event level should show up (screenshot to be replaced)
Clear Data
A user can opt to clear the data from the entire event (if all data contained in that event belongs to that specific user). When clearing event data a reason has to be documented.
After confirming the user will receive a warning that this actions induces a deletion of all forms within the event and a second confirmation has to be provided.
Navigation
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.
