CTA Adverse Event Reporting 3

Question 1

During a monitoring visit, a CTA finds that a site has been recording 'headache' as an SAE for all subjects. What is the most likely issue?

Accepted Answer

The site is misapplying the seriousness criteria

Answer

Headache is typically a non-serious AE unless it meets specific seriousness criteria; the site appears to be misapplying the ICH definition of 'serious.'

Question 2

Which document at the site level serves as the primary source for tracking and reconciling all reported adverse events?

Accepted Answer

The Adverse Event Log (AE Log)

Answer

The Adverse Event Log is the site-level source document used to capture, track, and reconcile all AEs and SAEs throughout the trial.

Question 3

If a subject dies during a clinical trial from a car accident unrelated to the study drug, how should this be classified?

Accepted Answer

Serious Adverse Event due to the outcome of death

Answer

Death is always classified as a Serious Adverse Event regardless of causality, because death is one of the defined seriousness criteria.

Question 4

What does 'unexpected' mean in the context of a SUSAR?

Accepted Answer

The nature or severity is not consistent with the current Investigator Brochure

Answer

An event is 'unexpected' when its nature, severity, or frequency is not consistent with the information in the current Investigator Brochure or reference safety information.

Question 5

A subject is hospitalized for a planned surgical procedure that was scheduled before trial enrollment. How should this be classified?

Accepted Answer

Not an SAE if the hospitalization was pre-planned and unrelated to the trial

Answer

ICH E6 and most protocols exclude planned/elective hospitalizations that are unrelated to the study from SAE criteria, provided this exclusion is specified in the protocol.

(CTA) Clinical Trial Associate Certification Practice Test

(CTA) Clinical Trial Associate Certification Practice Test

CTA Adverse Event Reporting 3