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
A subject in a Phase III oncology trial develops a life-threatening cardiac arrhythmia that is not listed in the Investigator Brochure. Which classification applies?
Answer: SUSAR — Suspected Unexpected Serious Adverse Reaction
The event is serious (life-threatening), suspected (no contrary evidence for attribution), and unexpected (not in the IB), meeting all three SUSAR criteria.
What is the purpose of the 'safety narrative' in an SAE report?
Answer: To provide a chronological medical summary of the event to aid clinical evaluation
The safety narrative provides a concise chronological summary of the event, treatments, and outcomes to facilitate clinical evaluation and regulatory review.
Which of the following events would NOT typically meet the FDA definition of a Serious Adverse Event?
Answer: A minor rash resolving within 24 hours without treatment
A minor rash resolving quickly without treatment does not meet any of the seriousness criteria (death, life-threatening, hospitalization, disability, congenital anomaly, or medical significance).
When should a sponsor submit a 'line listing' of all serious adverse events to the FDA?
Answer: As part of the annual IND safety report (Annual Report)
A line listing and summary of all IND safety reports submitted during the year must be included in the Annual IND Safety Report submitted to the FDA.
A CTA is reconciling SAEs between the site's AE log and the sponsor's safety database. What is the goal of this reconciliation?
Answer: To identify and resolve discrepancies ensuring all SAEs are fully captured in both systems
SAE reconciliation ensures that every SAE recorded at the site is captured in the sponsor's safety database and that no discrepancies exist between the two sources.
Under GCP, which of the following must always accompany an initial SAE report even if information is incomplete?
Answer: At minimum: subject identifier, event description, seriousness criteria, and date of onset
GCP and regulatory guidelines allow an initial SAE report with minimal required data (subject ID, event, seriousness criteria, onset date) to ensure timely reporting, with follow-up data submitted as available.
An investigator disagrees with the sponsor's causality assessment, believing an SAE is unrelated to the study drug when the sponsor assesses it as related. How should this be handled?
Answer: Both assessments should be documented; the more conservative (related) assessment is used for regulatory reporting
Regulatory guidance requires documenting both the investigator's and sponsor's causality assessments; the more conservative assessment (related) is used for expedited reporting purposes.