Risk Assessment & Management Flashcards
7 cards from real CPI practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Risk Assessment & Management flashcards as text
Which risk assessment method assigns numerical probabilities to outcomes and calculates expected monetary value?
Answer: Quantitative risk analysis
Quantitative risk analysis uses numerical data and probability estimates to calculate expected monetary value and other numerical risk metrics.
A principal investigator discovers mid-study that a protocol amendment is needed due to unexpected safety data. The FIRST action should be to:
Answer: Notify the IRB and sponsor before making changes
Protocol amendments generally require IRB review and sponsor notification before implementation, except in cases of immediate participant danger.
The risk matrix approach classifies risks based on which two primary dimensions?
Answer: Likelihood and impact
A risk matrix plots risks on two axes: the likelihood (probability) of occurrence and the impact (consequence) if the risk occurs.
Which strategy involves sharing the financial consequences of a risk with another party, such as through insurance?
Answer: Risk transfer
Risk transfer shifts the financial burden of a risk to another party, commonly through insurance contracts or contractual arrangements.
In research risk management, a 'residual risk' refers to:
Answer: The risk remaining after all mitigation measures have been applied
Residual risk is the level of risk that remains after risk controls and mitigation strategies have been implemented.
When a study team identifies a risk that has low probability but catastrophic potential impact, the BEST response is to:
Answer: Develop a contingency plan and monitor closely
Low-probability but high-impact risks warrant contingency planning and active monitoring even though immediate intensive mitigation may not be justified.
Which document formally records identified risks, their probability, impact, mitigation strategies, and responsible parties?
Answer: Risk register
A risk register is the central repository that documents all identified risks along with their attributes, mitigation plans, and ownership.