Record an adverse event

What this is, and who it is for#

An event is something that happens to a participant off the schedule: an adverse event, a medication started, another event the study tracks. It has a form of its own, designed for the study (Design forms), and a place in the participant's Events page and in the study's AE Log. An adverse event that is serious is upgraded, which starts a reporting clock and opens the safety trail (Review a serious event).

Held by: Principal Investigator, Clinical Research Coordinator (clinical.event.write).

Where to find it#

A participant's AEs & medications page (tables of Adverse events, Serious adverse events, Concomitant medications and Other events, each with a Record … button); a visit's Events found at this visit list; and the study's AE Log, one entry per adverse event, read from each event's own form.

What you can do#

Record an event#

1. On the Events page choose Record adverse event (or Record medication, Record other event); or Record event here on a visit. The dialog Record an event: Something that happened to the subject off the schedule: an adverse event, a medication started. It has a form of its own to fill in.
2. What kind of event (the kinds the design has; This study's design has no event form to record. A designer adds one in Build. otherwise).
3. What happened: in your words, with what you know now. The form takes the detail.
4. Found at: A visit or A contact (a call, a letter or a meeting that is not a visit).
5. Choose Record event. The event form opens: fill it in and submit it like any form (Enter visit data). Each event form has a kind that the designer sets in Build (ae adverse event, sae serious adverse event, conmed concomitant medication, other) and standard fields the logs read by their role: for an adverse event the term, description, onset, end, medications, relatedness, severity, outcome and note; for a medication the medication, dose, unit, route, indication, start, stop and remarks.

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1. Opens the dialog that records an event.

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1. Causality as the site judged it.

Record a contact#

Record a contact (A call, a letter or a meeting with the subject that is not a visit. An event learned of at a contact can be linked to it.): How you were in touch, When it took place, What it was about. A contact can be removed with a reason. Contacts are the record of attempts to reach a participant before they are declared lost to follow-up.

Close, upgrade, correct, remove#

Each event row's Actions:

• Open form: the event's form.
• Upgrade to serious…: for an adverse event that turns out to be serious (below).
• Correct awareness time…: change when the site became aware of a serious event (below).
• Mark the event closed / reopen: Closing says the event is finished and nothing more will be added. The dialog lists what is still open on it (queries, follow-ups) before you confirm.
• Remove…: with a reason; the event stays in the record, marked Removed, and leaves the logs' default view (the log has Include removed events).

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Upgrade to serious#

Choose Upgrade to serious… on an adverse event. The dialog asks:

The event now appears in the SAE Log with its report status Report pending and a due time. A serious adverse event is the upgrade of an adverse event; both forms must exist in the design (Design forms).

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1. Makes the event a serious adverse event and starts its reporting clock from the time of awareness.

Mark the initial report sent#

On the SAE Log or the Events page, Mark report sent (or not required) with the date: This says the initial report went to the regulator, and when. It is final: a report that was sent cannot be withdrawn or reopened here, and its awareness time can no longer be changed. Trialion does not send the report; it records that you did (Not built yet).

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Correct the awareness time#

Correct awareness time… moves the deadline: it asks Why the time is being corrected (recorded).

Every option#

The logs#

The AE Log and the SAE Log list one entry per event, with filters and sort, and an Export of each to CSV or Excel (Export data). The SAE Log shows the report status, the due time, an overdue flag, the follow-ups, the medical review and the reconciliation. Site staff see the report and follow-up columns but not the medical review or reconciliation.

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What the system records#

event.recorded, event.upgraded_to_sae, event.status_changed, event.removed, event.awareness_changed, event.report_status_changed, contact.recorded, contact.removed, plus the form's own field-level audit. See Audit events.

What you cannot do, and why#

• Delete an event. It is removed with a reason and kept.
• Withdraw or reopen a sent report, or change its awareness time.
• Record an event with no event form in the design.
• Review or reconcile as a site person (a different permission).

Compliance Q&A#

Related#

Review a serious event · Safety reporting · Change a participant's status · Report a deviation