CCRA Adverse Event Management 2

Question 1

An 'adverse event of special interest' (AESI) differs from a standard SAE in that it:

Accepted Answer

Is predefined in the protocol as requiring expedited reporting regardless of standard seriousness criteria

Answer

Is always fatal

Answer

Can only occur in Phase I trials

Answer

Does not require documentation in the CRF

Question 2

What is the difference between an Adverse Event (AE) and an Adverse Drug Reaction (ADR)?

Accepted Answer

An ADR implies at least a possible causal relationship to the study drug, while an AE does not require causality

Answer

An AE is always more serious than an ADR

Answer

An ADR applies only to marketed drugs, not investigational products

Answer

An AE requires hospitalization while an ADR does not

Question 3

The 15-day reporting clock for an expedited IND safety report begins when:

Accepted Answer

The sponsor first receives minimum valid safety information about the SUSAR

Answer

The subject reports symptoms to the site staff

Answer

The CRA documents the event in the monitoring report

Answer

The IRB is notified of the event

Question 4

A 'protocol-defined SAE exemption' means:

Accepted Answer

Certain SAEs anticipated by the disease or procedure do not require expedited reporting to the sponsor if specified in the protocol

Answer

The sponsor can waive all SAE reporting for a trial

Answer

IRB approval is not required for exempt SAEs

Answer

Subjects are not informed about exempt SAEs

Question 5

Which entity is responsible for assessing the causality (relatedness) of an adverse event to the investigational product?

Accepted Answer

The investigator, and separately the sponsor's medical monitor

Answer

The subject or patient

Answer

The CRA during the monitoring visit

Answer

The IRB during the annual review

Question 6

In clinical trials, 'outcome' for an adverse event typically refers to which of the following classifications?

Accepted Answer

Recovered/resolved, recovering/resolving, not recovered/not resolved, recovered with sequelae, fatal, unknown

Answer

Mild, moderate, severe, life-threatening, fatal

Answer

Related, possibly related, unrelated, unknown

Answer

Expected, unexpected, serious, non-serious