Quickly see the difference between AE, SAE, ADE, SADE, and USADE, plus device deficiencies, so everyone on the team is using the same language.
Know when safety events and device deficiencies must be reported to the sponsor, IRB, and others — so you don’t miss a required deadline.
Use the guide as a checklist when reviewing events, documenting details, and deciding what needs to be escalated, whether you’re a coordinator, investigator, or sponsor.
Your go-to overview of device safety reporting—clear, accurate, and aligned with regulations.
This printable pulls together the safety terms and reporting expectations that matter most in medical device trials. It covers events from AE to USADE, includes device deficiencies, and highlights reporting timelines consistent with ISO 14155:2020 and 21 CFR 812. Instead of flipping between guidance documents, your team gets the essentials in one place. Whether you’re a new coordinator, student, investigator, or sponsor, this guide makes it easier to recognize events, decide what needs to be reported, and understand who needs to be notified. Designed for quick understanding and real-world use, it’s a great addition to any regulatory binder, training packet, or device-trial toolkit. Keep it nearby—you’ll use it more often than you expect. Licensed for individual or single-site use. Full licensing details can be found at catalog.cliniq.academy/pages/license-agreement.
Stop stressing over safety reporting in medical device trials.
Your quick-reference sheet for AE, SAE, ADE, SADE, USADE, and device deficiencies — designed for sites, investigators, students, and sponsors who want clear, confident reporting.
$5.00