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 a Suspected Unexpected Serious Adverse Reaction (SUSAR) in the context of clinical trial safety reporting?
Answer: A serious adverse reaction that is both unexpected and reasonably suspected to be caused by the investigational product
A SUSAR is a serious adverse reaction that is both unexpected (not in the IB) and where there is a reasonable causal relationship suspected with the investigational product.
In which clinical trial document should a CRA verify that all SAEs have been properly documented and reconciled?
Answer: The Case Report Form (CRF) and source documents
CRAs must verify that SAEs are documented in both the CRF and source documents, and that any discrepancies between them have been resolved.
What is the key purpose of a safety review committee (SRC) in a clinical trial?
Answer: To review aggregate safety data and provide recommendations to protect participant safety
A safety review committee evaluates aggregate safety data across the study to identify safety signals and make recommendations to protect participant safety.
Which ICH guideline specifically addresses the Clinical Safety Data Management and defines standards for expedited reporting of individual case safety reports?
Answer: ICH E2A
ICH E2A defines clinical safety data management and the standards for expedited reporting of adverse drug reactions, including definitions and timeframes.
An investigator fails to report an SAE to the sponsor within the protocol-specified timeframe. What is the CRA's appropriate course of action?
Answer: Document the deviation, issue a protocol deviation report, and notify the sponsor's clinical team
The CRA must document the reporting deviation, complete a protocol deviation report, and escalate to the sponsor's clinical team so appropriate corrective action can be taken.
Which of the following best describes the process of 'signal detection' in clinical trial safety monitoring?
Answer: The systematic identification of new or changed safety information from aggregate adverse event data
Signal detection involves systematically reviewing aggregate adverse event data to identify new, unexpected, or changing safety patterns that may require further investigation.