CTA CTA Pharmacovigilance & Drug Safety 1

Question 1

What is pharmacovigilance?

Accepted Answer

The science and activities related to detection, assessment, understanding, and prevention of adverse effects of medicines

Answer

Pharmacovigilance encompasses the activities designed to detect, assess, understand, and prevent adverse effects or any other drug-related problems throughout the product lifecycle.

Question 2

What is a Serious Adverse Event (SAE) in clinical trials according to ICH E6?

Accepted Answer

An event that results in death, is life-threatening, requires hospitalization, causes disability, or is a congenital anomaly

Answer

Per ICH E6, an SAE is any adverse event that results in death, is life-threatening, requires inpatient hospitalization, causes persistent disability, or is a congenital anomaly/birth defect.

Question 3

What differentiates an adverse event (AE) from an adverse drug reaction (ADR)?

Accepted Answer

An AE is any untoward occurrence regardless of causality; an ADR implies a causal relationship to the drug

Answer

An AE is any undesirable event regardless of suspected causality to the drug, while an ADR requires that a causal relationship to the drug is at least a reasonable possibility.

Question 4

What is an Investigational New Drug (IND) safety report?

Accepted Answer

A report submitted to the FDA about unexpected serious adverse reactions that may affect participant safety

Answer

IND safety reports are expedited reports submitted to the FDA when there is a suspected unexpected serious adverse reaction (SUSAR) or new safety information that could affect participant safety or alter the trial conduct.

Question 5

What is the timeframe for reporting a fatal or life-threatening unexpected SUSAR to the FDA under IND regulations?

Accepted Answer

7 calendar days

Answer

Under 21 CFR 312.32, fatal or life-threatening unexpected SUSARs must be reported to the FDA within 7 calendar days of the sponsor's initial receipt of the information.

(CTA) Clinical Trial Associate Certification Practice Test

(CTA) Clinical Trial Associate Certification Practice Test

CTA CTA Pharmacovigilance & Drug Safety 1