CCA CATO Associate Safety Reporting & Adverse Events 2

Question 1

What is the purpose of an Individual Case Safety Report (ICSR)?

Accepted Answer

To report a single patient's adverse event to regulatory authorities and pharmacovigilance databases

Answer

To summarize all adverse events at study completion

Answer

To document protocol deviations

Answer

To notify the IRB of study amendments

Question 2

Which ICH guideline provides the framework for clinical safety data management and expedited reporting of adverse drug reactions?

Accepted Answer

ICH E2A

Answer

ICH E6 (GCP)

Answer

ICH E8

Answer

ICH E10

Question 3

Under GCP, what must be included in the source documentation when recording an adverse event?

Accepted Answer

Date of onset, description, severity, relationship to IP, action taken, and outcome

Answer

Only the severity grade

Answer

Only events that required hospitalization

Answer

The subject's insurance information

Question 4

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

Accepted Answer

An AE is any untoward event regardless of causality; an ADR implies a causal relationship to the medicinal product

Answer

There is no difference; the terms are interchangeable

Answer

An ADR is only applicable to marketed drugs, not investigational products

Answer

An AE occurs only in placebo recipients

Question 5

Who is responsible for submitting IND annual safety reports to the FDA for a US clinical trial?

Accepted Answer

The Sponsor

Answer

The Principal Investigator

Answer

The IRB/IEC

Answer

The CRO project manager

Question 6

What is a 'follow-up safety report' in clinical trial pharmacovigilance?

Accepted Answer

An updated report submitted when new information becomes available after the initial SAE report

Answer

A report submitted only when the subject recovers

Answer

A report filed by the IRB 30 days after the SAE

Answer

A report generated at study lock