CPI Risk Assessment & Management 3

Question 1

The concept of 'risk appetite' in research management refers to:

Accepted Answer

The level of risk an organization is willing to accept to achieve objectives

Answer

Risk appetite defines how much uncertainty an organization is prepared to accept in pursuit of its objectives before action is deemed necessary.

Question 2

A Data Safety Monitoring Board (DSMB) serves which primary risk management function in clinical research?

Accepted Answer

Providing independent oversight of participant safety and study data

Answer

A DSMB independently monitors accumulating safety and efficacy data to protect participant welfare and study integrity.

Question 3

When performing a root cause analysis after an adverse event, the '5 Whys' technique is used to:

Accepted Answer

Iteratively question causes until the fundamental source is identified

Answer

The 5 Whys technique drills down through successive layers of causation by asking 'why' repeatedly until the root cause is revealed.

Question 4

Which federal regulation requires IRBs to assess whether risks to participants are minimized and reasonable in relation to anticipated benefits?

Accepted Answer

45 CFR Part 46

Answer

45 CFR Part 46 (the Common Rule) requires IRBs to ensure risks are minimized and reasonable relative to anticipated benefits before approving research.

Question 5

In risk management, a 'trigger' is best defined as:

Accepted Answer

An early warning indicator that a risk event may be approaching

Answer

A risk trigger is a predefined warning sign or indicator that signals a risk is about to occur or has increased in likelihood.

(CPI) Certified Principal Investigator Practice Test

(CPI) Certified Principal Investigator Practice Test

CPI Risk Assessment & Management 3