[00:14:35] Serious Adverse Event - Flowchart
[00:15:56] Adverse Drug Reaction
[00:16:01] Adverse Drug Reaction (ADR)
[00:16:54] Causality Assessment
[00:18:18] "Unexpected" Adverse Drug Reaction
[00:19:44] Example of "Unexpected AE"
relation to the study product, but a potential alternative
etiology exists which may explain the event. An event is
considered to be "unrelated" if it is definitely related to an
etiology other than the study product. It is becoming more
common to categorize causality (or relatedness) as
Yes/No, rather than list the choices on the slide and to
provide the investigator with a checklist of additional
possible causes. For example, using the
00:17:43 / 00:49:10