Tick the outcomes the event had, then enter severity, causality and expectedness. The tree returns whether the event is serious, which criteria it meets, and whether it is a SUSAR candidate, with a summary you can paste into the AE form.
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1. Seriousness
Death, life-threatening, hospitalisation, disability, anomaly, important medical event
2. Severity
Intensity: mild, moderate, severe. Not the same as serious
3. Causality
Reasonable possibility that the product caused it
4. Expectedness
Is it in the reference safety information?
Serious adverse events in brief
Free tool
The defaults show a moderate event that needed an admission, judged related and unexpected. Change any answer and the result updates. Nothing is saved or sent.
Seriousness: SERIOUS Criteria met: Requires inpatient hospitalisation or prolongs an existing one Severity (intensity): moderate Causality: related / reasonable possibility Expectedness: unexpected Outcome of this tool: Serious, unexpected, suspected related (SUSAR candidate) Decision aid only: the investigator and sponsor medical assessment governs.
Decision aid, not validated software and not a regulatory determination. Seriousness is a regulatory classification based on outcome (ICH E2A, 21 CFR 312.32). It is separate from severity, causality and expectedness. The investigator and the sponsor's medical reviewer make the assessment, using the protocol and the reference safety information in force. Nothing is stored or sent: the answers stay in your browser.
The criteria
The six criteria come from ICH E2A (clinical safety data management: definitions and standards for expedited reporting) and are mirrored in the US IND safety reporting rule, 21 CFR 312.32. They are deliberately about what happened to the participant, not about what the clinician thought of the event.
Death is an outcome, not an event term. The event that led to death is what you report, with the date and the cause if known. Life-threatening means the participant was at immediate risk of death when the event occurred. It does not mean the event might have been fatal if it had been worse, which would make almost every event qualify. Hospitalisation means inpatient admission or a longer stay than planned. An emergency room visit that ends in discharge is not hospitalisation by itself, and an admission planned before the study, or for a pre-existing condition that has not worsened, does not make an event serious.
Persistent or significant disability or incapacity covers a substantial disruption of a person’s ability to carry out normal life functions. It does not have to be permanent, but a few days of discomfort is not enough. A congenital anomaly or birth defect applies to a child or foetus exposed to the product, including through a parent. The last category, important medical event, is a judgement call for events that do not meet the other criteria but may jeopardise the participant or need intervention to prevent one of them. Commonly quoted examples are allergic bronchospasm needing intensive treatment in an emergency room, convulsions that do not lead to admission, and the development of drug dependence.
| Question | Scale | Who decides | What it drives | |
|---|---|---|---|---|
| Seriousness | Serious or not (outcome) | Investigator, sponsor reviews | SAE reporting to sponsor | |
| Severity | Mild, moderate, severe (or CTCAE grade) | Investigator | Clinical management, analysis | |
| Causality | Related or not (protocol scale) | Investigator, sponsor may upgrade | SUSAR status | |
| Expectedness | Listed or not listed | Sponsor, against reference safety information | SUSAR status |
Worked examples
Invented events, answered the way the tool would answer them. Real cases need clinical judgement and the reference safety information.
| Event | Severity | Seriousness criterion | Causality, expectedness | Result |
|---|---|---|---|---|
| Severe migraine, treated at home | Severe | None | Related, listed | Non-serious AE |
| Mild rash, seen in the emergency room and discharged | Mild | None (no admission) | Related, listed | Non-serious AE |
| Mild dizziness and a fall, admitted overnight for observation | Mild | Hospitalisation | Related, not listed | SUSAR candidate |
| Planned knee replacement for arthritis that has not changed | Moderate | None (planned, pre-existing) | Not related, n/a | Non-serious, record as procedure |
| Anaphylaxis treated in the emergency room, discharged | Severe | Important medical event | Related, listed | SAE, not a SUSAR |
| Fatal road traffic accident | Severe | Death | Not related, n/a | SAE, report to sponsor |
| Admission for raised liver enzymes | Moderate | Hospitalisation | Related, not listed | SUSAR candidate |
Row 4 is the usual trap: a planned admission is not an adverse event outcome unless the condition worsened or a complication occurred. Row 1 shows that severe does not mean serious.
After the tree
The investigator tells the sponsor straight away, within the time the protocol sets, and follows up with a complete report. The sponsor then reviews seriousness, causality and expectedness against the investigator’s brochure or product information in force. If the event is serious, unexpected and has a reasonable possibility of a causal relationship, it is a SUSAR in EU and ICH terms and a serious and unexpected suspected adverse reaction under 21 CFR 312.32. That is the point at which the reporting clocks start. Use the SAE reporting deadline calculator for the dates, and see the SUSAR reporting software page for how that workflow is run.
Causality needs its own structured process. Investigators usually pick from a protocol scale (not related, unlikely, possible, probable, definite), and the sponsor can disagree. The AE causality assessment page covers how to record the reasoning, and the CTCAE grade lookup helps with the severity grade, which is a separate field. The forms themselves are on the adverse event eCRF template and the SAE report form template.
Raise a test SAE in the free sandbox and follow it through the alert, the acknowledgement and the investigator sign-off.
In Capture
Once the tree says serious, the work is recording and routing it. Capture keeps the adverse event form, the safety alert, the acknowledgement and the sign-off on one audit trail, so the dates the clocks depend on are evidenced.
SAE timeline
SAE reported
Day 0 · 09:12
Safety alert acknowledged
Medical monitor · 09:40
Site staff attestation
Study coordinator · 11:05
AE sign-off (PI / Sub-I)
Awaiting signature
Common mistakes
Grade 3 or severe is not an SAE criterion. Check the six outcomes first and the grade second.
Write down planned procedures and pre-existing conditions at baseline so the admission can be recognised as planned.
Record whether the participant was admitted. Observation under 24 hours rules differ between sponsors, so the protocol should say.
Expectedness is judged against the reference safety information, not against whether the condition is common in this population.
An event first recorded as non-serious becomes serious if the participant is later admitted. Reassess and date it.
An adverse event is any untoward medical occurrence in a participant given a product, whether or not it is related to it. It becomes a serious adverse event if it results in death, is life-threatening, needs inpatient hospitalisation or prolongs one, causes persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is an important medical event.
Severe describes intensity, such as a severe headache. Serious is a regulatory classification based on outcome. A severe event can be non-serious and a mild event can be serious, for example when it leads to hospitalisation.
Not on its own. An admission planned before the study, or for a pre-existing condition that has not worsened, is not normally treated as a serious adverse event. If the condition worsened or a complication occurred, the event may be serious. The protocol should state how planned admissions are handled.
A SUSAR is a serious adverse reaction that is unexpected and suspected to be related to the product. Unexpected means its nature or severity is not consistent with the reference safety information. In the US the equivalent term is a serious and unexpected suspected adverse reaction under 21 CFR 312.32.
The investigator assesses seriousness and causality at the site. The sponsor reviews both and assesses expectedness against the reference safety information, and can upgrade causality. Your protocol and safety management plan name the roles and the time limits.
No. It applies the published criteria to the answers you give and cannot replace medical judgement. Read ICH E2A and the rules that apply to your study, and follow the protocol.
No. The answers stay in your browser and are not saved or transmitted.
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