Adverse Event Reporting Timeline Agent

Serious adverse events must be reported to the sponsor and ethics board within strict timelines, and missing one is a major compliance finding. Whenever new notes are entered, this agent scans visit notes and participant reports for possible adverse events. It flags those that may be serious, such as hospitalizations, and starts the reporting clock. It drafts the report from source information and tracks follow-up information requests. Before review, it checks that the report is complete. If fields are missing, it lists what is needed and checks again once added. The investigator reviews and signs the report; the agent never decides seriousness or causality on its own. Edge case: a hospitalization discovered days later starts the clock from when the site learned of it, not from the event date.