CPI Risk Assessment & Management 2 — Questions and Answers
Question 1: Which risk assessment method assigns numerical probabilities to outcomes and calculates expected monetary value?
- Qualitative risk analysis
- Quantitative risk analysis (Correct answer)
- SWOT analysis
- Delphi technique
Correct answer: Quantitative risk analysis
Quantitative risk analysis uses numerical data and probability estimates to calculate expected monetary value and other numerical risk metrics.
Question 2: A principal investigator discovers mid-study that a protocol amendment is needed due to unexpected safety data. The FIRST action should be to:
- Implement the change immediately to protect participants
- Notify the IRB and sponsor before making changes (Correct answer)
- Document the change and proceed with enrollment
- Suspend the study pending regulatory approval
Correct 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.
Question 3: The risk matrix approach classifies risks based on which two primary dimensions?
- Cost and timeline
- Likelihood and impact (Correct answer)
- Frequency and severity
- Probability and detectability
Correct 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.
Question 4: Which strategy involves sharing the financial consequences of a risk with another party, such as through insurance?
- Risk avoidance
- Risk mitigation
- Risk transfer (Correct answer)
- Risk acceptance
Correct answer: Risk transfer
Risk transfer shifts the financial burden of a risk to another party, commonly through insurance contracts or contractual arrangements.
Question 5: In research risk management, a 'residual risk' refers to:
- The risk remaining after all mitigation measures have been applied (Correct answer)
- Risks identified late in the study
- Historical risks from previous similar studies
- Risks that cannot be categorized
Correct 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.
Question 6: When a study team identifies a risk that has low probability but catastrophic potential impact, the BEST response is to:
- Accept the risk since it is unlikely to occur
- Apply maximum mitigation efforts regardless of cost
- Develop a contingency plan and monitor closely (Correct answer)
- Eliminate the activity that creates the risk
Correct 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.
Question 7: Which document formally records identified risks, their probability, impact, mitigation strategies, and responsible parties?
- Risk appetite statement
- Risk register (Correct answer)
- Hazard log
- Safety monitoring report
Correct answer: Risk register
A risk register is the central repository that documents all identified risks along with their attributes, mitigation plans, and ownership.
CPI Risk Assessment & Management 2
Which risk assessment method assigns numerical probabilities to outcomes and calculates expected monetary value?