A SUSAR is a serious adverse reaction that is also unexpected. Getting there takes three judgements and a clock. Capture captures the SAE with the minimum dataset, raises an alert, records causality and sign-off, and keeps the timeline, so the sponsor’s safety team can decide and submit in time.
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SAE entered at site
Minimum dataset complete, alert raised
Alert acknowledged
Named safety contact, audit record
Causality recorded
Investigator: related
Expectedness assessed
Against the reference safety information
Expedited report decision
Sponsor safety team, 7 or 15 day clock
SUSARs in brief
7 / 15
calendar days for expedited SUSAR reports
5
fields in the enforced AE minimum dataset
2
signatures: site attestation and PI sign-off
Free
sandbox to rehearse a test SAE, no time limit
The method
Seriousness is the investigator’s call, using the standard criteria: death, life-threatening, hospitalisation or prolongation, persistent or significant disability, congenital anomaly, or another important medical event. Seriousness is not the same as severity. A severe headache can be non-serious, while a mild-sounding event that needs hospitalisation is serious. The seriousness decision tree walks through the criteria.
Causality asks whether there is a reasonable possibility that the product caused the event. Both the investigator and the sponsor assess it. Under the usual EU practice the sponsor can raise but not downgrade the investigator’s assessment, so a case the site calls related stays related unless the investigator changes it. An event with no reasonable possibility of a causal link is an SAE, not a suspected adverse reaction, and drops out of SUSAR reporting. See AE causality assessment software.
Expectedness compares the reaction with the reference safety information (RSI), which in most trials sits in the investigator’s brochure, or in the product information for an authorised product used within its label. A reaction that is listed with the same specificity and severity is expected. One that is not listed, or is more severe or specific than listed, is unexpected. The RSI version in force on the day of onset matters, so records need to say which one was used. A reaction that is unexpected but not serious is not a SUSAR.
Put together: serious plus related plus unexpected means SUSAR. Serious, related and expected is reported in periodic safety reporting and not on the expedited clock. The deadlines and the three regimes are laid out in the SAE reporting deadline calculator.
Responsibilities
| Step | Decision owner | In Capture |
|---|---|---|
| Record the event with the minimum dataset | Site investigator or delegate | AE form enforces term, onset date, seriousness and severity or grade; causality required when serious |
| Flag it serious and tell the sponsor | Investigator | Serious event raises a safety alert, routed through study notification rules |
| Acknowledge and triage | Sponsor safety contact | Alert acknowledgement with an audit record |
| Investigator causality | Investigator | Causality field on the SAE record, signed off by the PI |
| Sponsor causality and expectedness against the RSI | Sponsor safety physician | Assessment recorded on the case; RSI version noted in the safety plan, outside the form |
| Decide whether it is a SUSAR and which clock applies | Sponsor safety team | SAE timeline from awareness to sign-off keeps the dates |
| Submit the expedited report | Sponsor | Outside Capture: submission is made through your own safety process |
Capture does not submit to EudraVigilance or CTIS, and it does not convert a case into a regulatory report file.
In Capture
The SAE form holds what the safety team needs: a complete minimum dataset, the investigator’s seriousness and causality, the site attestation and the PI or sub-investigator sign-off under electronic signature. A serious event raises a safety alert straight away, and the alert has to be acknowledged, so the first clock-relevant fact, when the sponsor knew, is a timestamp, not a recollection.
Open SAEs
4
Awaiting acknowledgement
1
Awaiting PI sign-off
2
Signed off
11
Day 2 of 7, fatal case
Day 5 of 15
Day 1 of 15
Blinded studies
In a blinded trial the assessment of a potential SUSAR often depends on what the participant received. Regulators expect the sponsor to unblind individual cases that qualify as serious and possibly related, so the report can state the actual product, while investigators and the wider team stay blinded. A good process names who can unblind, records the reason and time, and keeps the blind intact for everyone else. Reporting an unblinded SUSAR to regulators does not mean unblinding the site.
In Capture blinded roles never receive treatment-arm values, which is enforced by masked database views and row-level security, not only by the interface. The investigational product panel on the AE form is blinded for blinded roles. That lets an unblinded safety contact work the case while blinded monitors and site staff keep seeing coded data. The role design and its limits are in blinded and unblinded role management, and emergency unblinding for a single participant is part of RTSM.
Plan the line between safety, the statistician and the data management team before the first participant. Decide who sees unblinded SAE listings, how the data monitoring committee receives them, and how the log of unblinding events is kept. These are protocol and safety-plan questions. Software can enforce them once they are written down.
Raise a serious event, acknowledge the alert and sign it off in a free sandbox with sample data. No credit card, no time limit.
Before the first event
Investigator to sponsor time stated, with any events that need no immediate reporting.
Who decides causality and expectedness, with weekend and holiday cover, since the days are calendar days.
The investigator’s brochure version in force is known to sites and recorded with each assessment.
Safety alerts reach a named contact, acknowledgement is required and logged.
Who may unblind a case, how it is logged and who stays blinded.
How expedited reports go to the regulator and ethics bodies, owned outside the EDC.
Safety database and clinical database reconciled regularly, with the reconciliation owner named.
Scope
Capture is an EDC with safety capture built in, not a pharmacovigilance database. It does not generate regulatory submission files for EudraVigilance, CTIS or FDA systems, and it does not make the SUSAR determination for you. What it provides is a controlled, time-stamped, signed record of each SAE that the safety team can work from. For studies with a safety database, the clinical record is the source of the case, and the reconciliation between the two is a safety management plan topic.
Related reading: the adverse event side is covered in adverse event reporting software, and teams working under the EU regime should also read EU CTR clinical trial software.
A suspected unexpected serious adverse reaction. It is an adverse event that is serious, has a reasonable possibility of being caused by the investigational product, and is not consistent with the reference safety information. SUSARs are reported to regulators on an expedited timeline.
Under the EU CTR (Article 42) the sponsor reports within 7 days for fatal or life-threatening cases and 15 days for others, from becoming aware. Under 21 CFR 312.32 it is 7 days from initial receipt for unexpected fatal or life-threatening reactions and 15 days from the sponsor’s determination otherwise. ICH E2A uses 7 and 15 days too.
No. Capture does not submit to EudraVigilance, CTIS or the FDA. It captures the SAE with the minimum dataset, routes alerts, records causality and sign-off and keeps the timeline, so the sponsor’s safety team can prepare the report.
The sponsor, by comparing the reaction with the reference safety information, usually in the investigator’s brochure. The investigator assesses seriousness and causality at the site, and the sponsor reviews them.
Individual cases that may be SUSARs are usually unblinded by the sponsor for reporting, while site staff and monitors stay blinded. In Capture, blinded roles never receive treatment-arm values, enforced at the database layer.
Yes. When an adverse event is marked serious, causality is required before it can be submitted, along with the AE term, onset date and severity or CTCAE grade.
Yes. The safety overview shows open and serious events, and the site risk monitor highlights sites with SAEs waiting for review.
Yes. The free sandbox includes AE and SAE forms with sample data and every feature, with no credit card and no time limit.
Keep exploring
Try SAE alerts, acknowledgement and PI sign-off in the free sandbox. No credit card; you pay only when you go live with real participants.