Three different questions. Three different definitions. Three different reporting implications. And the distinctions between them are not academic -- they determine what gets reported, to whom, and how fast.

I have watched coordinators struggle with these definitions more than almost any other topic in safety reporting, and the reason is straightforward: the terms sound similar, the abbreviations blur together, and everyday English assigns these words meanings that differ from their regulatory definitions. "Serious" does not mean "bad." "Severe" does not mean "serious." "Adverse event" does not mean "side effect." Every one of these colloquial assumptions will lead you astray.

This lesson establishes the precise definitions that the rest of this course -- and your practice -- depends upon. We will work through each term methodically, and by the end, the distinctions will be not just memorized but understood.

Three different questions. Three different definitions. Three different reporting implications. And the distinctions between them are not academic -- they determine what gets reported, to whom, and how fast.

I have watched coordinators struggle with these definitions more than almost any other topic in safety reporting, and the reason is straightforward: the terms sound similar, the abbreviations blur together, and everyday English assigns these words meanings that differ from their regulatory definitions. "Serious" does not mean "bad." "Severe" does not mean "serious." "Adverse event" does not mean "side effect." Every one of these colloquial assumptions will lead you astray.

This lesson establishes the precise definitions that the rest of this course -- and your practice -- depends upon. We will work through each term methodically, and by the end, the distinctions will be not just memorized but understood.