Trained on the actual workflow, not a generic module
Sessions walk through the study's own reporting workflow and timelines, so sites know exactly what to do when an event occurs.
What's included
What goes into training
- SAE identification and seriousness/expectedness criteria covered for the specific protocol and investigational product
- Reporting timelines walked through against the requirements set in the Safety Management Plan
- The intake and routing steps built in SAE Reporting Workflow Setup demonstrated end to end
- Role-specific guidance for sites versus CRAs, reflecting each group's part in getting an event reported on time
- Training delivered and documented before the site is activated, with materials available for reference during conduct
- Refresher content coordinated with External SOP Training & Familiarization as procedures are updated
Documented and kept current
Completion is tracked before activation, with refreshers coordinated alongside ongoing SOP training through conduct.