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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'.
Anepoch 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.
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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.
You can
- view the audit trail (
) up to that specific level, - add comments,
- clear the event(group)
The comment icon will display the number of comments already added on that specific location.
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- Query on event level should show up (screenshot to be replaced)
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.