Safety reporting
Report adverse events and SAEs, follow them up and sign them off.
- Report an adverse eventOpen the participant and click Add AE (or the + in the Casebook AE column). Enter the adverse event term, onset date, severity and whether it is serious, then click Submit. If it is serious, the form asks for more and the safety team is notified at once.For Site coordinators & staff, Investigators
- 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.For Site coordinators & staff, Investigators
- Follow up or close an adverse eventOpen the adverse event, click Edit, add the new information and save with a reason. To close it, enter the Resolution date and Outcome. For an SAE, every saved change sends a follow-up notice to the safety team.For Site coordinators & staff, Investigators
- Sign off an adverse event as investigatorOpen the submitted adverse event and click Complete AE Sign-off. Read the meaning statement, type your full name and password, tick the confirmation and click Sign & Authorize. Principal Investigators can delegate AE sign-off to Sub-Investigators.For Investigators
- Confirm you received a safety notificationClick the confirmation link in the SAE email and then Confirm acknowledgement, or click the check mark next to the alert under the safety bell at the top of the screen. Receipt is recorded for you only; the event still needs its review and sign-off.For Investigators, Sponsors & CROs, Study owners & admins, Monitors (CRAs)
- Review all adverse events on the Safety pageClick the shield bell at the top of the screen and choose View All Safety Data. The Safety page lists every adverse event with seriousness, onset, awareness, reporting status, AE sign-off and coding status. Click a row for the event timeline and reporting clocks.For Investigators, Sponsors & CROs, Study owners & admins, Monitors (CRAs), Data managers
- Add a MedDRA dictionary for coding adverse eventsOpen your name at the top right > Sponsors & MedDRA, create the sponsor, then on the MedDRA tab upload the MedDRA English ASCII release zip with its version number and confirm your organization holds a MedDRA licence.For Study owners & admins, Sponsors & CROs
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.