What this is, and who it is for
Once an adverse event has been upgraded to serious, the system keeps its safety trail: the initial report and its clock, the follow-up reports, the medical monitor's review and the reconciliation with the safety database. Each is a record of what people did. The system does not generate an expedited report, submit anything, or compare with the safety database; it records that you did.
| You need | To |
|---|---|
clinical.event.report (project manager, data manager, medical officer, principal investigator) | Record a follow-up report, mark it sent or remove it |
clinical.event.review (medical officer) | Record the medical review |
clinical.event.reconcile (project manager, data manager) | Record the reconciliation |
clinical.event.read | See the trail (the review and reconciliation are hidden from site staff) |
Held by: Medical Officer (clinical.event.review).
Held by: Project Manager, Data Manager (clinical.event.reconcile).
Where to find it
The SAE Log ("One entry per serious adverse event, with its report, the reporting clock and what follows it. Open an entry to see the form."): columns for the report, the awareness and due times, Follow-up, Medical review and Reconciliation, with an Overdue count, filters and a site selector. Each entry's menu (Open the event) and the event's page show the Safety trail: Follow-up reports, the medical review and the reconciliation with the safety database.
What you can do
Follow-up reports
When the site learns something new, record it. Record follow-up information: When did the site learn it?, What was learned (what the site now knows that the last report did not say). The follow-up has its own deadline: A follow-up report is due within the version's follow-up window of this time (360 hours, 15 days, unless the version says otherwise; the window is fixed when it is recorded). Each follow-up is numbered (Follow-up #2) and starts Pending.
- Mark as sent: This says the follow-up report went to the regulator, and when. It is final: a follow-up that was sent cannot be withdrawn, re-timed or removed here.
- Remove… a follow-up recorded in error, with the reason: It stays on record with its number and your reason, and is no longer counted. A follow-up that was sent cannot be removed: a correction is a new follow-up.
Medical review (medical officer)
- On the entry, choose Medical review. Your assessment of the report: Agreed, Disagreed or Needs information.
- Causality: Related, Not related or Not assessable, judged against the reference safety information in the Investigator's Brochure or the product information, not against the protocol. Expectedness: Expected, Unexpected or Not assessable. A related and unexpected event is flagged SUSAR (a suspected unexpected serious adverse reaction): a flag only; it starts no clock and sends nothing.
- A Comment (at least six characters), and Raise a query to the site if the site must answer something.
- Record review. You did not record this event, so you may review it. A later review replaces this one in the log; every review stays on the event. The site does not see medical reviews.
- Opens the medical review dialog.
- Required when causality is Related.
Reconciliation with the safety database (project manager or data manager)
Reconciliation with the safety database: Result: Matched or Discrepancy; Safety case ID (the number in the safety database); Day compared; a note (at least six characters). The latest reconciliation is shown in the log. The study cannot be locked while a serious event that requires a report is not reconciled as matched (Close and lock a study).
- Records the reconciliation by hand; nothing is compared automatically.
The safety follow-up of a withdrawn participant
When a participant is withdrawn with Follow-up required, the participant's page shows a safety follow-up card; Mark the safety follow-up complete records What the follow-up was, who completed it and when, with the note; it does not undo the withdrawal.
Every option
The clock
| Time | From | Default |
|---|---|---|
| Initial report due | The time of awareness | 24 hours (version setting Initial report due within, 1 to 720) |
| Follow-up report due | The time the site learned the new information | 360 hours (version setting, 1 to 2,160) |
Both are set per version in Study Settings (Settings) and frozen with it. A report status is Report pending, Reported or Report not required. The log shows the due time and flags a pending report past it as overdue.
What blocks a lock
A serious event whose initial report is overdue, or that is not reconciled as matched, blocks the database lock.
What the system records
event.follow_up_recorded, event.follow_up_status_changed, event.follow_up_removed, event.review_recorded, event.reconciliation_recorded, event.report_status_changed, subject.safety_follow_up_completed. Reviews, reconciliations and follow-ups are append-only: a later one is added; none is edited. See Audit events.
What you cannot do, and why
- Generate or submit an expedited report, or an E2B file. Not built; you record that it was sent.
- Receive a reminder that a deadline is near. There is no notification (Notifications); watch the SAE Log's overdue count.
- Review as the site, or let the site see the review.
- Edit a review, a reconciliation or a sent follow-up. Add a new one.
- Reconcile with the safety database automatically. The reconciliation is a record a person makes.
Compliance Q&A
Yes as a record. Each step is a row with the person and the time, none is overwritten, the reviewer cannot be the person who recorded the event, the site cannot see the review, and an overdue report or an unreconciled event stops the database lock.
Limits: nothing is generated or transmitted (no E2B file, no gateway), the comparison with the safety database is a person's entry, and nobody is told that a deadline is near.
Evidence: server/src/modules/study/events, safety-logs (event_follow_ups, event_reviews, event_reconciliations append-only)lock readiness blockers
Related
Record an adverse event · Safety reporting · Close and lock a study · Not built yet · Medical Officer