Risk Management & Quality Assurance Flashcards
7 cards from real CRP 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 Management & Quality Assurance flashcards as text
Which of the following best describes 'risk tolerance' in research organizations?
Answer: The level of risk an organization is willing to accept in pursuit of its objectives
Risk tolerance defines the acceptable variation in outcomes that an organization is prepared to accept while still pursuing its research goals.
In clinical research, 'blinding' is a risk mitigation strategy primarily designed to control which type of bias?
Answer: Performance and detection bias
Blinding prevents participants and/or investigators from knowing treatment assignments, thereby reducing performance bias (behavior changes) and detection bias (outcome assessment).
A sponsor's quality management plan specifies 'risk-based monitoring.' What distinguishes this approach from traditional 100% source data verification?
Answer: It focuses monitoring resources on critical data and highest-risk sites
Risk-based monitoring uses data review and targeted on-site visits to concentrate oversight on areas with the greatest potential impact on patient safety and data integrity.
Which document establishes the responsibilities and expectations for quality systems between a sponsor and a CRO?
Answer: The quality agreement or transfer of obligations document
A quality agreement (or transfer of obligations) formally delineates which GCP responsibilities the sponsor retains versus those delegated to the CRO.
According to ICH E6(R2), essential documents must be retained for at least how long after the completion or discontinuation of a trial?
Answer: As specified by applicable regulatory requirements, typically at least 2 years after the last approval of marketing application
ICH E6(R2) requires retention of essential documents for at least 2 years after the last approval of a marketing application in an ICH region, or as otherwise required by regulations.
What is the main purpose of performing a 'root cause analysis' after a quality event in research?
Answer: To identify the underlying systemic cause so it can be permanently eliminated
Root cause analysis investigates the fundamental reason a problem occurred so that effective corrective actions can be implemented to prevent recurrence.
A study team notices enrollment is 40% below target at month 6. Which risk response strategy is most appropriate as a first step?
Answer: Analyze barriers and implement recruitment enhancement strategies
Analyzing the root causes of underenrollment and implementing targeted recruitment strategies (adding sites, expanding eligibility review) is the appropriate initial risk mitigation response.