Adverse event reporting that never misses the minimum
Capture enforces the regulatory minimum dataset on every AE, routes serious events to the right people and collects investigator sign-off under an e-signature. Safety data sits in the same record as the rest of the study.
- Minimum dataset enforced
- SAE alerts and sign-off
- MedDRA coding
Free sandbox · No credit card · 21 CFR Part 11 aligned
Cannot submit yet
Causality is required because the event is serious.
5
fields in the enforced AE minimum dataset
2
signatures: site attestation and PI sign-off
1
safety overview across every site
E2B
safety export available
Recording
Every AE complete before it is submitted
Sites can save a partial draft, but submission checks the regulatory minimum and names exactly what is missing. The check runs on the server too, so it cannot be skipped.
- AE term, onset date, seriousness and severity or CTCAE grade always required.
- Causality required whenever the event is serious.
- Partial onset dates such as UNK-JUN-2026 accepted.
- Onset and resolution dates kept consistent.
Cannot submit yet
Causality is required because the event is serious.
Serious events
SAEs routed, timed and signed off
A serious event raises a safety alert straight away. Capture tracks the SAE timeline, collects the site attestation and the investigator sign-off, and records who acknowledged the alert.
- Safety alerts with acknowledgement and an audit record.
- SAE timeline from awareness to sign-off.
- Site staff attestation plus PI or sub-investigator sign-off, including under delegation.
- Meaning statement stored with each signature.
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
Special interest
AESIs, lab findings and coding in one flow
Adverse events of special interest get their own categories and form, linked to the SAE when needed. A clinically significant lab result can raise an AE without losing the lab entry.
- AESI categories with a dedicated form and SAE linkage.
- Raise an AE straight from a clinically significant lab value.
- MedDRA coding with dictionaries scoped to your sponsor, or run without MedDRA.
- Investigational product panel on the AE form, blinded for blinded roles.
| Analyte | Result | Range | Significant? |
|---|---|---|---|
| ALT | 212 U/L | 7-56 | Yes |
| Creatinine | 0.9 mg/dL | 0.6-1.2 | - |
Alert value
Routed to the medical monitor and PI
One step
Raise adverse event from this result
Report a test SAE end to end
Raise, route and sign off a sample SAE in a free sandbox.
Oversight
See safety across every site
The safety overview shows totals, open events, SAEs and severity, and the site risk monitor flags sites with SAEs waiting for review.
- Total, open and serious events at a glance.
- Severity breakdown and recent events.
- Sites with overdue SAE reviews highlighted.
- Safety exports, including E2B.
What does adverse event reporting software do?
It records adverse events during a trial, checks they are complete, escalates serious events and captures the investigator assessment and sign-off, with a full audit trail.
Which AE fields are mandatory?
AE term, onset date, seriousness and severity or CTCAE grade are required on submission, and causality is required when the event is serious.
How are SAEs escalated?
A serious event raises a safety alert that is routed through the study notification rules and must be acknowledged. The SAE timeline tracks it through to sign-off.
Who signs off an AE?
Site staff attest to the record, then the PI or a sub-investigator signs off, including under delegation. Both are electronic signatures with a meaning statement.
Is MedDRA coding supported?
Yes. MedDRA dictionaries are scoped to your sponsor organisation, and studies can also run without MedDRA coding.
Can lab results trigger an AE?
Yes. A clinically significant lab result can raise an AE directly, without losing the lab data already entered.
Can safety data be exported?
Yes, including safety listings and an E2B export.
Can I try it?
Yes. The free sandbox includes AE and SAE forms with sample data.
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