SOCRA CCRP Adverse Events

Question 1

How is a 'Serious Adverse Event' (SAE) defined under ICH GCP?

Accepted Answer

Any untoward medical occurrence that results in death, is life-threatening, requires hospitalization, or causes disability

Answer

Any adverse event that causes discomfort

Answer

An event that causes a protocol deviation

Answer

Any adverse event considered related to the study drug

Question 2

What is the difference between an 'adverse event' (AE) and an 'adverse drug reaction' (ADR)?

Accepted Answer

An AE is any untoward event; an ADR implies a causal relationship to the investigational product

Answer

There is no difference

Answer

An ADR is more severe than an AE

Answer

An AE only applies to approved drugs

Question 3

Under FDA regulations, what is the timeframe for expedited reporting of an unexpected fatal or life-threatening SAE to the FDA?

Accepted Answer

7 calendar days

Answer

24 hours

Answer

15 calendar days

Answer

30 calendar days

Question 4

What does 'SUSAR' stand for in clinical research?

Accepted Answer

Suspected Unexpected Serious Adverse Reaction

Answer

Serious Unexpected Study Adverse Reaction

Answer

Subject Under Safety Adverse Review

Answer

Sponsor Unreported Safety Adverse Report

Question 5

Who is primarily responsible for assessing causality of an adverse event to the study drug?

Accepted Answer

The investigator

Answer

The data safety monitoring board

Answer

The study sponsor

Answer

The regulatory authority

Question 6

What does 'unexpected' mean when describing an adverse event in a clinical trial?

Accepted Answer

An event not listed or not consistent with the nature or severity described in the Investigator's Brochure

Answer

An event not previously seen in any patient population

Answer

An event the investigator was not aware of

Answer

An event that occurs suddenly without warning