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
According to 21 CFR Part 312.32, within how many calendar days must a sponsor report a non-fatal, non-life-threatening unexpected serious adverse event to the FDA?
Answer: 15 calendar days
21 CFR 312.32 requires sponsors to report non-fatal, non-life-threatening unexpected serious adverse events to the FDA within 15 calendar days.
What is the difference between an Adverse Event (AE) and a Treatment-Emergent Adverse Event (TEAE)?
Answer: A TEAE is an AE that was absent at baseline or worsened after study treatment began
A Treatment-Emergent Adverse Event (TEAE) is any AE that was not present before administration of the study drug or that worsened in severity after treatment initiation.
When a blinded clinical trial has a suspected unexpected serious adverse reaction, how should the sponsor handle unblinding for safety reporting?
Answer: Unblind only the subject's treatment assignment for the specific SUSAR report
The sponsor may unblind the specific subject's treatment assignment for SUSAR reporting while maintaining the blind for all other subjects to preserve trial integrity.
Which ICH guideline specifically addresses clinical safety data management and definitions for expedited reporting?
Answer: ICH E2A
ICH E2A provides the definitions and standards for expedited safety reporting during clinical trials, including criteria for SUSARs and reporting timelines.
A CTA notices that an investigator has not submitted a required SAE report to the IRB within the protocol-specified 10-day window. What is the most appropriate immediate action?
Answer: Document the finding, notify the sponsor, and request the investigator submit the report promptly
The CTA should document the finding as a protocol deviation, escalate to the sponsor, and work with the investigator to submit the overdue report as soon as possible.
In a clinical trial, 'causality assessment' for an adverse event is primarily performed by:
Answer: The Principal Investigator or treating physician
Causality assessment — determining the likelihood that an AE is related to the investigational product — is the clinical judgment of the Principal Investigator or treating physician.
What is a 'suspected adverse reaction' (SAR) as defined by the FDA under 21 CFR 312.32?
Answer: An AE for which there is a reasonable possibility that the drug caused the event
Under 21 CFR 312.32, a Suspected Adverse Reaction is any AE for which there is a reasonable possibility — meaning evidence suggests a causal relationship — that the drug caused the event.