SOCRA Adverse Event Safety Reporting 4

Question 1

In causality assessment, 'dechallenge' refers to:

Accepted Answer

The improvement or resolution of an adverse event after the investigational drug is withdrawn

Answer

Dechallenge is the observation that an AE improves or resolves after stopping the investigational product, which supports a causal relationship.

Question 2

A subject in a Phase II trial develops severe liver injury that is unexpected and has a reasonable causal relationship to the investigational drug. This event is best classified as:

Accepted Answer

A suspected unexpected serious adverse reaction (SUSAR)

Answer

An event that is serious, unexpected (not in the IB), and possibly caused by the investigational drug meets the definition of a SUSAR requiring expedited reporting.

Question 3

Which factor is LEAST relevant when assessing causality between an adverse event and an investigational drug?

Accepted Answer

The subject's health insurance plan and coverage type

Answer

A subject's insurance status has no bearing on the clinical or pharmacological assessment of whether a drug caused an adverse event.

Question 4

Which regulatory body requires safety data for clinical trials conducted in the European Union to be submitted via the EudraVigilance database?

Accepted Answer

European Medicines Agency (EMA)

Answer

The European Medicines Agency (EMA) requires sponsors and marketing authorization holders to submit individual case safety reports (ICSRs) through the EudraVigilance electronic reporting system.

Question 5

When assessing causality, a 'positive rechallenge' refers to:

Accepted Answer

The AE recurring or worsening when the investigational drug is reintroduced after a dechallenge

Answer

A positive rechallenge — where the AE reappears upon reintroduction of the drug — substantially strengthens evidence of a causal relationship.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA Adverse Event Safety Reporting 4