CTA CTA Pharmacovigilance & Drug Safety

Question 1

What is pharmacovigilance?

Accepted Answer

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

Answer

The process of manufacturing drugs under sterile conditions

Answer

The regulatory review of new drug applications

Answer

The statistical analysis of clinical trial data

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

Any undesirable experience regardless of severity

Answer

Any event that causes the participant to withdraw from the study

Answer

An event that reduces the drug's effectiveness

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 always serious; an ADR is never serious

Answer

An ADR only applies to marketed products; an AE only applies to clinical trials

Answer

There is no meaningful difference between an AE and an ADR

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

A report submitted to the IRB before a new protocol is initiated

Answer

A report submitted to CROs about drug supply issues

Answer

A report documenting protocol deviations during a trial

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

15 calendar days

Answer

30 calendar days

Answer

45 calendar days

Question 6

What does 'unexpected' mean in the context of a Suspected Unexpected Serious Adverse Reaction (SUSAR)?

Accepted Answer

The adverse reaction is not consistent in nature or severity with the Investigator's Brochure or product labeling

Answer

The adverse reaction was not anticipated by the investigator

Answer

The adverse reaction occurred in fewer than 1% of participants

Answer

The adverse reaction was reported at only one study site