Report a serious adverse event (SAE)
On the AE form, answer Yes to Is this a Serious Adverse Event (SAE)?, choose the causality and seriousness criteria, and complete the SAE expanded report, including the date the investigator became aware. Click Submit SAE. The safety team is notified straight away and the investigator is asked to sign off.
Where to find it
AE form > Is this a Serious Adverse Event (SAE)? > Yes
Before you start
- You are site staff with data-entry rights: Principal Investigator, Sub-Investigator or Study Coordinator.
Report the SAE
Start an adverse event as usual (report an adverse event).
Answer Yes to Is this a Serious Adverse Event (SAE)?.
Choose the Causality to IMP and tick the Serious criteria (ICH E2A): death, life-threatening, hospitalisation, prolonged hospitalisation, disability, congenital anomaly or important medical event.
Complete Action & outcome: action taken, any treatment given and the outcome.
In SAE expanded report (24h expedited), enter the reporter and the Date investigator became aware, plus hospital dates, relevant history, medications, results and a narrative.
The awareness date starts the 24-hour reporting clock.
Click Submit SAE.
What happens next
- A safety report is created with its deadlines: site to sponsor within 24 hours of awareness, and the regulatory clock.
- The investigator, the sponsor-side safety roles and the medical monitor get an email. For confidentiality it contains no event details, only a sign-in link and a link to confirm receipt (acknowledge a safety notification).
- The site's Principal Investigator gets a separate request to complete AE sign-off.
- Each later change to the SAE sends a follow-up notice. An SAE is never downgraded automatically.
Questions
What makes an adverse event serious?
An event is serious if it results in death, is life-threatening, requires or prolongs hospitalisation, causes persistent disability, is a congenital anomaly, or is another important medical event. See serious adverse event (SAE).
Why does the SAE email not include the details?
To protect participant confidentiality, safety emails are a notice and a sign-in link only. All details are in Capture behind your sign-in.
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Still need help?
Email support@capture.study or use the contact form. Tell us the study name, what you were trying to do and the exact message on screen; a screenshot helps.
Please never send participant names, contact details or health information to support.