CTA Adverse Event Reporting 3 — Questions and Answers
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?
- The investigator is over-reporting to be cautious
- The site is misapplying the seriousness criteria (Correct answer)
- The protocol defines headache as always serious
- The IRB requires reporting all AEs as SAEs
Correct 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.'
Question 2: Which document at the site level serves as the primary source for tracking and reconciling all reported adverse events?
- The Investigator Brochure
- The Adverse Event Log (AE Log) (Correct answer)
- The Drug Accountability Log
- The Delegation Log
Correct 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.
Question 3: If a subject dies during a clinical trial from a car accident unrelated to the study drug, how should this be classified?
- Not reportable since it is unrelated to the drug
- Serious Adverse Event due to the outcome of death (Correct answer)
- Adverse Drug Reaction requiring expedited reporting
- Minor Adverse Event since the drug is not implicated
Correct 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.
Question 4: What does 'unexpected' mean in the context of a SUSAR?
- The event has never been reported in any patient population
- The nature or severity is not consistent with the current Investigator Brochure (Correct answer)
- The event occurs in fewer than 1% of trial subjects
- The investigator did not anticipate the event at enrollment
Correct 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.
Question 5: A subject is hospitalized for a planned surgical procedure that was scheduled before trial enrollment. How should this be classified?
- SAE — hospitalization always qualifies
- Not an SAE if the hospitalization was pre-planned and unrelated to the trial (Correct answer)
- Adverse Drug Reaction requiring immediate sponsor notification
- Protocol deviation requiring IRB reporting
Correct 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.
Question 6: Which of the following best describes the role of the Data Safety Monitoring Board (DSMB) in adverse event reporting?
- It replaces the sponsor's pharmacovigilance department
- It independently reviews accumulating safety and efficacy data to recommend trial continuation, modification, or termination (Correct answer)
- It is responsible for submitting IND safety reports to the FDA
- It conducts monitoring visits to verify SAE documentation
Correct 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.
Question 7: 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?
- Open a new SAE case in the safety database
- Cross-reference it with the original SAE report and update the existing case (Correct answer)
- Discard it if the original report was already submitted to the FDA
- Send it directly to the FDA without sponsor review
Correct 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.
CTA Adverse Event Reporting 3
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?