CPI Adverse Event Management & Reporting Flashcards
6 cards from real CPI practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 CPI Adverse Event Management & Reporting flashcards as text
What does SUSAR stand for in clinical trial safety reporting?
Answer: Suspected Unexpected Serious Adverse Reaction
SUSAR stands for Suspected Unexpected Serious Adverse Reaction, the term used in ICH E2A and EMA guidelines for expedited safety reports.
Which ICH guideline provides the framework for clinical safety data management and expedited adverse drug reaction reporting?
Answer: ICH E2A
ICH E2A defines clinical safety data management, including definitions and standards for expedited reporting of serious adverse drug reactions during clinical development.
Under 21 CFR 312.32, within what timeframe must a non-fatal, non-life-threatening unexpected serious adverse drug reaction be reported to the FDA?
Answer: 15 calendar days
Non-fatal, non-life-threatening unexpected serious adverse drug reactions must be reported to the FDA as an IND safety report within 15 calendar days.
What is a 'causality assessment' in the context of adverse event reporting?
Answer: An evaluation of the likelihood that the study drug caused or contributed to an adverse event
Causality assessment is the process of evaluating whether a reasonable causal relationship exists between the investigational product and an observed adverse event.
Which of the following qualifies as a criterion for classifying an adverse event as 'serious'?
Answer: Persistent or significant disability or incapacity
Persistent or significant disability or incapacity is one of the six FDA-defined criteria that classify an adverse event as serious.
What is the primary role of a Data Safety Monitoring Board (DSMB) in a clinical trial?
Answer: To independently review accumulating safety data and recommend trial continuation, modification, or stopping
A DSMB is an independent committee that periodically reviews unblinded safety and efficacy data to protect subjects and ensure ongoing trial integrity.