CPI Risk Assessment & Management 2

Question 1

Which risk assessment method assigns numerical probabilities to outcomes and calculates expected monetary value?

Accepted Answer

Quantitative risk analysis

Answer

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:

Accepted Answer

Notify the IRB and sponsor before making changes

Answer

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?

Accepted Answer

Likelihood and impact

Answer

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?

Accepted Answer

Risk transfer

Answer

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:

Accepted Answer

The risk remaining after all mitigation measures have been applied

Answer

Residual risk is the level of risk that remains after risk controls and mitigation strategies have been implemented.

(CPI) Certified Principal Investigator Practice Test