Module 6: Quiz about Adverse Event Reporting

Which of the following is the most correct definition of an Adverse Event (AE) according to ICH GCP?

Anything which happens to a subject/patient in a trial.

Any untoward medical occurrence which happens to a subject/patient in a trial.

What is the difference between an Adverse Event and an Adverse Drug Reaction?

An Adverse Drug Reaction is related to the trial drug but an Adverse Event is not.

There is no difference.

An Adverse Drug Reaction is a response to the trial drug and an Adverse Event may or may not be a response to the trial drug.

An Adverse Event is reported in a clinical trial and an Adverse Drug Reaction is the term used in pre-clinical research.

Which of the following is not considered Adverse Event?

Pre-existing condition

Worsening of pre-existing condition after the subject started on the treatment with the trial drug.

Procedure planned prior to signing informed consent

What are the purposes of AE reporting?

To ensure safety of the subjects during the trial.

To establish a safety profile of the drug and ensure accurate labeling.

It is mandated by the authorities.

The subject called the investigator for advice because he had mistakenly administered a double dose of the trial drug. He was advised to come to the clinic for a check-up. The subject did not experience any adverse events as a consequence of the incorrect dose administered. What should be reported to the sponsor?

Report as overdose as medication error.

Report as accidental overdose as medication error.

Do not report.

Which of the following are seriousness criteria?

Persistent or significant disability

Congenital or birth defects

Medically significant or important medical events

Hospitalization or prolongation of existing hospitalization

Life-threatening

Death

During the screening visit, an ECG of a patient shows first degree AV-block. Should this be reported as an adverse event?

Yes

In the reference safety information, headache is listed as a common adverse drug reaction of the trial drug. The subject reported severe migraine after taking the trial drug. Is this adverse event expected?

Yes

Who is responsible for the ongoing safety evaluation of the investigational product (trial drug)?

Investigator

Sponsor

IEC/IRB

Local regulatory authority

What does SUSAR stand for?

Serious, Unrelated Study Adverse Reaction

Suspected Unrelated Serious Adverse Reaction

Suspected Unexpected Serious Adverse Reaction

A patient developed pneumonia which required penicillin treatment but no hospitalisation. The investigator did not think that it was related to the trial drug. Which category should it be reported as?

An adverse event

A SUSAR

A serious adverse event

A patient in a clinical trial got a botox injection (which has nothing to do with the trial) and had a severe reaction to botox. Is this an adverse event?

Yes

No, but it should be reported anyway.

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Module 6: Quiz about Adverse Event Reporting

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