What this is, and who it is for
A protocol deviation is a departure from the protocol: a visit out of window, an eligibility breach, a dose given wrongly, a procedure not done. Reporting it makes a record against the participant (and the site) that the study's Protocol Deviations report counts. Deviations are reported by people at the site and by those who monitor it; they are classified by severity, flagged if they are important, and can be marked reportable to the regulator or ethics committee.
| You need | To |
|---|---|
deviation.report (project manager, data manager, medical officer, clinical research associate, principal investigator, coordinator) | Report a deviation and change its status |
clinical.query.read | See deviations |
Held by: Project Manager, Clinical Research Associate, Data Manager, Medical Officer, Principal Investigator, Clinical Research Coordinator (deviation.report).
Where to find it
A participant's page → Deviations ("Departures from the protocol reported for this participant"), with Report deviation; and the study's Reports → Protocol Deviations.
What you can do
- Choose Report deviation. The dialog is Report protocol deviation: Recorded against this subject and surfaced on Reports > Protocol Deviations.
- Fill in:
| Field | Notes |
|---|---|
| Date it happened | Required; a real date, not in the future |
| Visit | The participant's visit it happened at, or Not at a visit |
| Category | Visit out of window, Eligibility breach, Dosing deviation, Procedure not done, Lab error, Consent issue, Source data missing |
| Severity | Minor, Major or Critical |
| Important deviation | It may affect the participant's rights, safety or the data that decide the study (ICH E3 section 10.2) |
| Reportable to the regulator or ethics committee | It is recorded with the status Reportable, which the study's Protocol Deviations report counts |
| Description | What happened, and how it deviates from the protocol |
- Choose Report deviation. A toast says Deviation reported.
Follow it up
On the participant's Deviations table (columns Happened, Visit, Category, Severity, Status, What happened, Reported, with an Important flag) choose Change status to move it: Open (the start), Under Review, Resolved (stamps the time it was resolved) or Reportable. Moving off Resolved clears that time.
See them all
Reports → Protocol Deviations lists the study's deviations with counts by severity and status, and by site (Use the reports and the dashboard).
- The day it happened, which is not the day it is reported.
- The visit it concerns.
Every option
Statuses
| Status | Meaning |
|---|---|
| Open | Reported, not yet looked at |
| Under Review | Being assessed |
| Resolved | Dealt with |
| Reportable | To be, or has been, reported to the regulator or ethics committee. A deviation reported as reportable starts here |
Other places a deviation shows
A visit marked Required flags a participant who misses it; the visit-compliance figure in the dashboard counts visits out of window (Plan visits). Those are reports, not deviation records: report a deviation when the protocol was not followed.
What the system records
deviation.reported and deviation.status_changed with the person, the time, the category, severity and (for a status change) the reason. See Audit events.
What you cannot do, and why
- Delete a deviation. Change its status.
- Report a deviation dated in the future.
- Report one without a description.
- Make the system report to the regulator. Reportable is a status; the report is yours to make.
Compliance Q&A
Yes. Each deviation is a record with its date, visit, category, severity, an importance flag and a status that can be reviewed and resolved; those reportable to the regulator or ethics committee are marked and counted, and every status change is attributed.
Limits: deviations are reported by a person; the system does not detect them, and nobody is notified when one is reported.
Evidence: server/src/modules/study/deviations (severity, important, reportable, status)audit events deviation.reported, deviation.status_changedReports > Protocol Deviations
Related
Use the reports and the dashboard · Run a visit · Clinical Research Associate