Adverse Event Reporting Flashcards
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Read the first 7 Adverse Event Reporting flashcards as text
Which regulatory agency requires IND safety reports (MedWatch Form FDA 3500A) for serious unexpected adverse drug reactions in the US?
Answer: FDA
The FDA requires IND safety reports using MedWatch Form FDA 3500A for serious unexpected adverse drug reactions occurring in US-regulated trials.
A subject in a clinical trial experiences a Grade 3 elevation in liver enzymes that resolves without sequelae. How should this be classified?
Answer: Serious Adverse Event (SAE)
A Grade 3 laboratory abnormality that requires medical intervention meets the 'medically significant' criterion for classification as a Serious Adverse Event.
What is the primary purpose of expedited safety reporting in clinical trials?
Answer: To allow regulators to assess benefit-risk and protect trial participants promptly
Expedited reporting enables regulators to rapidly assess the benefit-risk profile of the investigational product and take protective action for trial participants.
Under ICH E6(R2), who is ultimately responsible for the timely reporting of SAEs to the sponsor?
Answer: The Principal Investigator
ICH E6(R2) places ultimate responsibility on the Principal Investigator to report SAEs to the sponsor immediately or within the timeframe specified by the protocol.
A SUSAR must be reported to the FDA within how many calendar days if the event is fatal or life-threatening?
Answer: 7 calendar days
Fatal or life-threatening unexpected serious adverse reactions (SUSARs) must be reported to the FDA within 7 calendar days of the sponsor first receiving information.
Which term describes an adverse event that a qualified medical expert considers to have a reasonable causal relationship to the investigational medicinal product?
Answer: Adverse Drug Reaction (ADR)
An Adverse Drug Reaction (ADR) specifically implies a causal relationship between the event and the investigational product, distinguishing it from a general AE.
What action should a CTA take if they discover that an SAE was not reported within the required timeframe?
Answer: Immediately notify the sponsor and document the deviation
A late SAE report is a protocol deviation that must be immediately escalated to the sponsor and fully documented to ensure transparency and regulatory compliance.