CRP Risk Management & Quality Assurance 2 — Questions and Answers
Question 1: Which risk management technique involves assigning numerical probabilities to potential research outcomes to quantify expected losses?
- Qualitative risk assessment
- Quantitative risk analysis (Correct answer)
- Risk avoidance
- Risk transfer
Correct answer: Quantitative risk analysis
Quantitative risk analysis assigns numerical probabilities and impact values to calculate expected monetary value or other numeric risk measures.
Question 2: A research sponsor requires a DSMB (Data Safety Monitoring Board) for a clinical trial. What is the primary function of the DSMB?
- Approve the study protocol before enrollment begins
- Provide ongoing review of accumulating safety and efficacy data (Correct answer)
- Audit financial expenditures of the research budget
- Recruit eligible participants for the study
Correct 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.
Question 3: In quality assurance, what does a 'process audit' specifically evaluate?
- The accuracy of final research data outputs
- Adherence to procedures and protocols during research activities (Correct answer)
- The qualifications of principal investigators
- Budget compliance with sponsor requirements
Correct 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.
Question 4: What is the purpose of a 'risk register' in research project management?
- Document all IRB submissions for the project
- Record identified risks, their likelihood, impact, and mitigation strategies (Correct answer)
- Track participant enrollment numbers over time
- List all regulatory agencies overseeing the study
Correct 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.
Question 5: Which GCP principle requires that research be conducted in accordance with a protocol approved by an IRB/IEC?
- Principle of beneficence
- Principle of protocol adherence (Correct answer)
- Principle of scientific validity
- Principle of equipoise
Correct 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.
Question 6: A researcher discovers that the randomization sequence was accidentally unblinded for 10 participants. This should be classified as:
- A protocol amendment requiring re-consent
- A protocol deviation that must be documented and reported (Correct answer)
- An adverse event requiring immediate medical intervention
- A data discrepancy requiring database lock
Correct 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.
Question 7: What is the function of a 'corrective and preventive action' (CAPA) plan in research quality management?
- Pre-screen participants before enrollment
- Address identified deficiencies and prevent their recurrence (Correct answer)
- Calculate statistical power for the study
- Allocate resources across multiple research sites
Correct 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.
CRP Risk Management & Quality Assurance 2
Which risk management technique involves assigning numerical probabilities to potential research outcomes to quantify expected losses?