CRA Adverse Event Reporting & Safety Monitoring Flashcards
6 cards from real CRA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 CRA Adverse Event Reporting & Safety Monitoring flashcards as text
What is the purpose of causality assessment in adverse event reporting during a clinical trial?
Answer: To assess whether the adverse event is related to the investigational product
Causality assessment determines the likelihood that an adverse event is related to the investigational product, which influences reporting obligations and safety decisions.
Which of the following is NOT a standard causality category used by investigators when assessing whether an adverse event is related to study drug?
Answer: Inevitably related
Standard causality categories include definitely, probably, possibly, unlikely, and unrelated; 'inevitably related' is not a recognized causality classification.
An investigator in a US clinical trial observes a new, unexpected serious adverse event that is possibly related to the study drug. To whom should this be reported first?
Answer: The sponsor within the timeframe specified in the protocol
Investigators must report SAEs to the sponsor within the timeframe specified in the protocol (typically 24–48 hours), and the sponsor then fulfills FDA reporting obligations.
What is the primary difference between an Adverse Event (AE) and an Adverse Drug Reaction (ADR) in clinical research?
Answer: An ADR has at least a reasonable causal relationship to the investigational product while an AE may not
An AE is any untoward event regardless of causality, while an ADR requires at least a reasonable possibility of a causal relationship with the investigational product.
During an ongoing blinded clinical trial, a sponsor receives an unblinded SAE report suggesting a potential safety signal. What is the appropriate first action?
Answer: Assess the SAE without unblinding to preserve trial integrity, unless unblinding is clinically necessary
Sponsors should assess the SAE to determine if unblinding is necessary; unnecessary unblinding compromises trial integrity, so it should only occur when clinically required.
Under 21 CFR 312.32(c)(1)(ii), within what timeframe must a sponsor submit an expedited IND safety report for an unexpected serious adverse drug reaction that is NOT fatal or life-threatening?
Answer: 15 calendar days
Unexpected serious adverse drug reactions that are not fatal or life-threatening must be reported to the FDA within 15 calendar days of the sponsor receiving the information.