ClinIQ Academy Catalog

Safety reporting is one of the most critical—and misunderstood—responsibilities at the research site level. Definitions, oversight expectations, reporting timelines, and IRB requirements often live in separate places, making it hard to see how they fit together in practice. This bundled series brings those pieces into a single, cohesive learning path for U.S.-regulated clinical trials. Across four focused sessions, you’ll learn how adverse events are defined across FDA, ICH, and ISO frameworks; how Principal Investigators are expected to evaluate and oversee safety events; how site teams determine what must be reported, to whom, and when; and how unanticipated problems provide a broader framework for identifying new or emerging risks to participants. Rather than treating safety topics in isolation, this series shows how decisions build on one another—from recognizing an adverse event, to assessing seriousness and relatedness, to documenting oversight, reporting appropriately, and communicating with IRBs and sponsors. Designed for real-world site practice, the series emphasizes clarity, consistency, and defensible decision-making—helping investigators and site teams move beyond uncertainty and approach safety reporting with confidence. If you support safety reporting at a clinical research site and want a clear, practical foundation you can rely on, this series delivers exactly that.