I’m refining a one-page AE/SAE reporting checklist for investigators to prevent delayed CIOMS submissions and missed signals — targeting 24-hour SAE notification and 7-day SUSAR reporting where required. If you have concise templates, training slides, or a reliable approach to reconcile EDC vs safety database within 48 hours for risk control and audit readiness, I’d appreciate examples that have worked at your sites.
We cut CIOMS delays by about 36 hours with a daily 10‑min “safety handshake” — data mgmt pulls new AEs from EDC, PV pulls new cases from the safety DB, we reconcile in a two‑column tracker and escalate anything unmatched at 24h (think pit stop, not post‑mortem). It only works if each side has a named owner; on your one‑pager, add a single checkbox line “EDC↔safety recon done within 48h” and the reminder “If it isn’t in the safety DB, it didn’t happen” — want a copy of the tracker?