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

An SAE is defined as any adverse event that results in death, is life-threatening, requires inpatient hospitalization, results in persistent disability, or is a congenital anomaly.

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

An AE is any untoward occurrence regardless of causality, while an ADR implies at least a reasonable causal relationship to the investigational medicinal product.

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

Unexpected, fatal or life-threatening SUSARs must be reported to FDA within 7 calendar days per 21 CFR 312.32.

Question 4

What does 'SUSAR' stand for in clinical research?

Accepted Answer

Suspected Unexpected Serious Adverse Reaction

Answer

SUSAR stands for Suspected Unexpected Serious Adverse Reaction — a serious adverse reaction that is unexpected and for which there is a reasonable causal relationship to the study drug.

Question 5

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

Accepted Answer

The investigator

Answer

Under GCP, the investigator is responsible for assessing the causal relationship between an adverse event and the investigational product.

SOCRA CCRP - SOCRA Certified Clinical Research Professional Practice Test

SOCRA CCRP - SOCRA Certified Clinical Research Professional Practice Test

SOCRA CCRP Adverse Events