Guided Notes
Safety Data & Pharmacovigilance for Data Managers
Adverse event data in depth — causality, expectedness, CTCAE grading, AESIs, pregnancy reporting, aggregate safety reviews, DSMBs and how CDM supports patient safety.
AE data in depth
Slide 1 / 5For each AE, trials usually collect: term, start/end dates (or ongoing), seriousness and criteria, severity or grade, relationship to study drug (causality), action taken with study drug, other treatment, outcome. Each element drives safety analyses — missing causality or outcome is a frequent query topic before lock.