CPI CPI Adverse Event Management & Reporting 2

Question 1

What does SUSAR stand for in clinical trial safety reporting?

Accepted Answer

Suspected Unexpected Serious Adverse Reaction

Answer

SUSAR stands for Suspected Unexpected Serious Adverse Reaction, the term used in ICH E2A and EMA guidelines for expedited safety reports.

Question 2

Which ICH guideline provides the framework for clinical safety data management and expedited adverse drug reaction reporting?

Accepted Answer

ICH E2A

Answer

ICH E2A defines clinical safety data management, including definitions and standards for expedited reporting of serious adverse drug reactions during clinical development.

Question 3

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?

Accepted Answer

15 calendar days

Answer

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.

Question 4

What is a 'causality assessment' in the context of adverse event reporting?

Accepted Answer

An evaluation of the likelihood that the study drug caused or contributed to an adverse event

Answer

Causality assessment is the process of evaluating whether a reasonable causal relationship exists between the investigational product and an observed adverse event.

Question 5

Which of the following qualifies as a criterion for classifying an adverse event as 'serious'?

Accepted Answer

Persistent or significant disability or incapacity

Answer

Persistent or significant disability or incapacity is one of the six FDA-defined criteria that classify an adverse event as serious.

(CPI) Certified Physician Investigator Practice Test

(CPI) Certified Physician Investigator Practice Test

CPI CPI Adverse Event Management & Reporting 2