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
The concept of 'risk appetite' in research management refers to:
Answer: The level of risk an organization is willing to accept to achieve objectives
Risk appetite defines how much uncertainty an organization is prepared to accept in pursuit of its objectives before action is deemed necessary.
A Data Safety Monitoring Board (DSMB) serves which primary risk management function in clinical research?
Answer: Providing independent oversight of participant safety and study data
A DSMB independently monitors accumulating safety and efficacy data to protect participant welfare and study integrity.
When performing a root cause analysis after an adverse event, the '5 Whys' technique is used to:
Answer: Iteratively question causes until the fundamental source is identified
The 5 Whys technique drills down through successive layers of causation by asking 'why' repeatedly until the root cause is revealed.
Which federal regulation requires IRBs to assess whether risks to participants are minimized and reasonable in relation to anticipated benefits?
Answer: 45 CFR Part 46
45 CFR Part 46 (the Common Rule) requires IRBs to ensure risks are minimized and reasonable relative to anticipated benefits before approving research.
In risk management, a 'trigger' is best defined as:
Answer: An early warning indicator that a risk event may be approaching
A risk trigger is a predefined warning sign or indicator that signals a risk is about to occur or has increased in likelihood.
An investigator notices that enrollment is falling behind schedule, potentially jeopardizing study completion. This is BEST classified as:
Answer: An operational risk
Enrollment shortfalls represent an operational risk that threatens study timelines, data integrity, and scientific validity.
The principle of ALARA in radiation research risk management stands for:
Answer: As Low As Reasonably Achievable
ALARA (As Low As Reasonably Achievable) is the guiding principle that radiation exposure should be kept as low as reasonably achievable beyond mandatory limits.