From an event at the site to a serious adverse event that is reported, followed up, medically reviewed, reconciled with the safety database and no longer in the way of the database lock. Trialion is the record of this chain; it does not send reports to regulators.
The flow
The handoffs
| # | Who | Does | Result |
|---|---|---|---|
| 1 | Coordinator or investigator | Records the event on its form (Record an adverse event) | An entry in the AE Log |
| 2 | Coordinator or investigator | Upgrades it to serious, giving when the site became aware and what makes it serious | An entry in the SAE Log; the initial report clock starts at the awareness time |
| 3 | The site sends the report to the regulator or the sponsor's safety desk, outside Trialion; the principal investigator, Project Manager, Data Manager or Medical Officer marks it sent | The report status becomes Reported; the awareness time can no longer change | |
| 4 | Principal investigator, Medical Officer, Data Manager, Project Manager | Record each follow-up as information arrives and mark it sent (Review and reconcile a serious adverse event) | Numbered follow-ups, each with its own deadline |
| 5 | Medical Officer | Records the medical review: assessment, causality, expectedness, comment | A review the site does not see; a related and unexpected event is flagged as a SUSAR |
| 6 | Project Manager or Data Manager | Reconciles the event with the safety database: matched or discrepancy, with the safety case id | The event stops blocking the lock when matched |
| 7 | Anyone with clinical.query.raise | Raises a query on a discrepancy, which the site answers | The usual cleaning loop (Capture and clean data) |
The gates
The clock starts at awareness, not at entry. The site states when it became aware that the event was serious. The initial report is due a number of hours after that (24 by default; the version can set 1 to 720), and a follow-up a number of hours after the site learned the new information (360 by default). Correcting the awareness time moves the deadline and needs a reason, until the report is sent; marking the report sent and correcting the time are for the investigator, the Project Manager, the Data Manager and the Medical Officer.
Reports are final once sent. A report marked sent cannot be withdrawn, reopened or re-timed here, and a follow-up that was sent cannot be removed: a correction is a new follow-up.
Review is independent. A reviewer cannot be the person who recorded the event, and the site never sees the medical review or the reconciliation.
The lock waits for safety. A serious event whose initial report is overdue, or that is not reconciled as matched, blocks the database lock (Close and lock a study).
What Trialion does not do
It does not generate or transmit an expedited report, an E2B file or a gateway message; it does not compute whether a SUSAR is reportable beyond the flag; and it sends no reminder when a deadline is near. Watch the SAE Log's overdue count (Not built yet).
Where this goes wrong
| Symptom | Cause |
|---|---|
| "There is no Upgrade to serious" | The design has no serious adverse event form, or you are not at the site: only the coordinator and the investigator write events |
| "The report shows overdue" | The initial report was not marked sent within the window from the awareness time |
| "I cannot change the awareness time" | The report has been marked sent |
| "The lock is blocked by a safety event" | An overdue initial report, or a serious event not reconciled as matched |
| "I cannot review this event" | You recorded it |
Do it
Record an adverse event · Review and reconcile a serious adverse event · Report a deviation
Compliance Q&A
Partly. Each step is recorded with the person and the time, none is overwritten, and an overdue or unreconciled serious event stops the lock.
Limits: the system records that a report was sent; it does not produce or send it, does not compute regulatory obligations beyond the SUSAR flag, and does not remind anyone of a deadline.
Evidence: server events and safety-logs (awareness-based clockappend-only follow-ups, reviews and reconciliationslock blockers)simulation of 20 Oct 2026, step 6.12 (upgrade, review, reconciliation and follow-up all worked)