research.embrace.kcl.ac.uk/safety/adverse-events/s/new-ae
LIVEStudy Coordinator
Admin indexSafety & safeguarding: isolated pathwayAdverse events & incidents

Capability 5.7 · Screen 44

Adverse events & incidents

AE/SAE register: clinical events, device malfunctions, AI-related issues, data problems; complete audit trail. 5.7.

State: new ae.This is a dedicated, reviewable product state at its own route.

REGISTER

Adverse events & incidents

  • Clinical · AE-042 · reviewing
  • Device malfunction · AE-041 · resolved
  • AI-related · AE-040 · held before delivery
  • Data issue · AE-039 · corrected
TRACE

Full trail

  • Source · assessment · action · approval · closure

Group G — Safety & safeguarding: isolated pathway · Screen 44

Adverse events & incidents

AE/SAE register: clinical events, device malfunctions, AI-related issues, data problems; complete audit trail. 5.7.

5.7