Adverse Event Reporting Flashcards
7 cards from real CTA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Adverse Event Reporting flashcards as text
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?
Answer: The site is misapplying the seriousness criteria
Headache is typically a non-serious AE unless it meets specific seriousness criteria; the site appears to be misapplying the ICH definition of 'serious.'
Which document at the site level serves as the primary source for tracking and reconciling all reported adverse events?
Answer: The Adverse Event Log (AE Log)
The Adverse Event Log is the site-level source document used to capture, track, and reconcile all AEs and SAEs throughout the trial.
If a subject dies during a clinical trial from a car accident unrelated to the study drug, how should this be classified?
Answer: Serious Adverse Event due to the outcome of death
Death is always classified as a Serious Adverse Event regardless of causality, because death is one of the defined seriousness criteria.
What does 'unexpected' mean in the context of a SUSAR?
Answer: The nature or severity is not consistent with the current Investigator Brochure
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.
A subject is hospitalized for a planned surgical procedure that was scheduled before trial enrollment. How should this be classified?
Answer: Not an SAE if the hospitalization was pre-planned and unrelated to the trial
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.
Which of the following best describes the role of the Data Safety Monitoring Board (DSMB) in adverse event reporting?
Answer: It independently reviews accumulating safety and efficacy data to recommend trial continuation, modification, or termination
The DSMB is an independent committee that reviews unblinded cumulative safety and efficacy data and makes recommendations about the trial's continuation or modification.
A CTA receives a 'follow-up' SAE report from an investigator providing additional information on a previously reported event. What should the CTA do first?
Answer: Cross-reference it with the original SAE report and update the existing case
Follow-up information should be matched to the original SAE report and used to update the existing case, ensuring completeness and regulatory compliance.