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 risk management technique involves assigning numerical probabilities to potential research outcomes to quantify expected losses?
Answer: Quantitative risk analysis
Quantitative risk analysis assigns numerical probabilities and impact values to calculate expected monetary value or other numeric risk measures.
A research sponsor requires a DSMB (Data Safety Monitoring Board) for a clinical trial. What is the primary function of the DSMB?
Answer: Provide ongoing review of accumulating safety and efficacy data
A DSMB independently monitors accumulating data to protect participant safety and ensure study integrity, with authority to recommend stopping the trial early.
In quality assurance, what does a 'process audit' specifically evaluate?
Answer: Adherence to procedures and protocols during research activities
A process audit examines whether research activities are being carried out according to defined procedures, SOPs, and protocols.
What is the purpose of a 'risk register' in research project management?
Answer: Record identified risks, their likelihood, impact, and mitigation strategies
A risk register is a centralized document cataloging identified risks along with their assessed probability, potential impact, and planned responses.
Which GCP principle requires that research be conducted in accordance with a protocol approved by an IRB/IEC?
Answer: Principle of protocol adherence
GCP requires strict adherence to the approved protocol, and any deviations must be documented and reported to the IRB/IEC.
A researcher discovers that the randomization sequence was accidentally unblinded for 10 participants. This should be classified as:
Answer: A protocol deviation that must be documented and reported
Unintended unblinding is a protocol deviation that must be documented, assessed for impact on data integrity, and reported per sponsor and IRB requirements.
What is the function of a 'corrective and preventive action' (CAPA) plan in research quality management?
Answer: Address identified deficiencies and prevent their recurrence
A CAPA plan documents the root cause of a quality problem, corrective steps taken, and systematic changes made to prevent future occurrences.