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Certified Biomedical Auditor (CBA)
#Question
An auditor notices that a clinical site uses outdated methodologies for data collection. What should be done?
A.Revisit previous methodologies
B.Document findings
C.Accept current methods
D.Recommend modernization of methods
Correct Answer:
D
Recommended modernization of methods ensures that clinical data collection adheres to current standards and regulations.
#Question
A company fails to meet industry standards for quality control. What should auditors prioritize?
A.Compliance improvement
B.Financial performance
C.Employee feedback
D.Marketing campaigns
Correct Answer:
A
Prioritizing compliance improvement is essential for addressing quality control failures and maintaining industry standards.
#Question
During the review of surveillance data, the auditor notes gaps in data reporting. What should be prioritized?
A.Identify potential bias
B.Assess participant feedback
C.Review statistical methods
D.Address data reporting gaps
Correct Answer:
D
Addressing data reporting gaps ensures data integrity and compliance with regulations governing reporting.
#Question
An auditor identifies that a facility is not complying with ethical recruitment practices. What should be the response?
A.Document the practices
B.Continue with recruitment
C.Randomize participant selection
D.Report the findings
Correct Answer:
D
Reporting the findings upholds ethical standards and ensures that recruitment practices are examined further.
#Question
If an auditor finds that corrective actions are not documented adequately, what should they suggest?
A.Implement corrective action documentation procedures
B.Continue with current practices
C.Escalate to regulatory agencies
D.Ignore documentation issues
Correct Answer:
A
Implementing documentation procedures helps ensure that corrective actions are tracked and managed effectively.
#Question
An auditor discovers inconsistent application of safety protocols throughout a facility. What action should be recommended?
A.Implement universal protocols
B.Conduct workplace safety training
C.Dismiss inconsistency
D.Increase recruitment processes
Correct Answer:
B
Conducting workplace safety training reinforces the importance of adhering to established safety protocols across the facility.
#Question
During a trial audit, an auditor notes that certain critical data points are not being collected. What should they prioritize?
A.Identify data collection gaps
B.Ignore the data points
C.Meet with management
D.Increase recruitment efforts
Correct Answer:
A
Identifying data collection gaps is crucial to ensure that all necessary data is captured for the integrity of the trial.
Certified Biomedical Auditor (CBA)
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