ACRP CCRA EXAM COMPREHENSIVE REVIEW WITH
UPDATED ACTUAL QUESTIONS AND CORRECT
ANSWERS
◉ In regards to AE and ADR reporting, what statements are true?
Answer: - All ADRs are AEs but not all AEs are ADRs
- Worsening in pre-existing medical conditions is an AE
-Preplanned hospitalization is usually not an SAE
◉ What determines the causality of an adverse event? Answer: The
investigator
◉ Which term best describes the cyclical process that involves the
Plan, Do, Check, Act activities? Answer: Quality improvement
◉ Which term best describes an independent assessment of
completed work to ensure it will meet applicable quality standards?
Answer: Quality assurance
◉ Which term best describes the activities done to ensure quality
output? Answer: Quality control
◉ Which term requires structure and a definition of acceptable
standards of performance? Answer: Quality planning
,◉ Which is represented in ALCOA-C? Answer: Attributable
◉ What does CAPA stand for? Answer: Corrective and Preventive
Action
◉ When not completed correctly, which is a major contributing
factor to an ineffective CAPA plan? Answer: Root cause analysis
◉ What are the cyclical activities performed a part of quality
improvement? Answer: Plan, Do, Check, Act
◉ What is sued to determine root causes? Answer: - Fishbone
diagram
- Process flow charts
- The 5 Whys
◉ What are fishbone diagrams, process flow charts, and the 5 whys
used for determining? Answer: Root causes
◉ What is the key difference between quality improvement and
quality assurance activities? Answer: Can be performed by persons
involved in doing the work.
,◉ What are the elements of quality management system? Answer: -
Quality planning
- Quality assurance
- Quality control
◉ What is part of a quality management plan? Answer: - Quality
policy statement
- Quality goals
- Organizational structure with defined roles
◉ What documents support quality control? Answer: - SOPS,
- Concomitant medication log
◉ Quality standards are set by? Answer: - Regulatory bodies
- IRB/IECs
◉ What are the basic steps of risk management? Answer: - Analyze
risk
- Identify risk
- Control risk
◉ Adhering to the principles represented in ALCOA-C support?
Answer: Good documentation practice.
, ◉ What are the correct order of steps CAPA performs? Answer: -
Identify issue
- Determine root cause
- Implement plan for correction
- Assess effectiveness of correction
◉ Having which two people sign and date the consent form is a
quality standard for the informed consent documentation? Answer:
The subject and the person obtaining consent.
◉ True or False. Moving away from preventing problems to
identifying and correcting problems is a key paradigm shift taking
place in clinical trial conduct. Answer: False
◉ True or False. When engaged in quality improvement activities,
it's important to identify who is to blame for quality failure? Answer:
False
◉ What skills are essential for making risk based decision making
successful? Answer: - Quality control skills
- Motivational skills
- Change management skills
UPDATED ACTUAL QUESTIONS AND CORRECT
ANSWERS
◉ In regards to AE and ADR reporting, what statements are true?
Answer: - All ADRs are AEs but not all AEs are ADRs
- Worsening in pre-existing medical conditions is an AE
-Preplanned hospitalization is usually not an SAE
◉ What determines the causality of an adverse event? Answer: The
investigator
◉ Which term best describes the cyclical process that involves the
Plan, Do, Check, Act activities? Answer: Quality improvement
◉ Which term best describes an independent assessment of
completed work to ensure it will meet applicable quality standards?
Answer: Quality assurance
◉ Which term best describes the activities done to ensure quality
output? Answer: Quality control
◉ Which term requires structure and a definition of acceptable
standards of performance? Answer: Quality planning
,◉ Which is represented in ALCOA-C? Answer: Attributable
◉ What does CAPA stand for? Answer: Corrective and Preventive
Action
◉ When not completed correctly, which is a major contributing
factor to an ineffective CAPA plan? Answer: Root cause analysis
◉ What are the cyclical activities performed a part of quality
improvement? Answer: Plan, Do, Check, Act
◉ What is sued to determine root causes? Answer: - Fishbone
diagram
- Process flow charts
- The 5 Whys
◉ What are fishbone diagrams, process flow charts, and the 5 whys
used for determining? Answer: Root causes
◉ What is the key difference between quality improvement and
quality assurance activities? Answer: Can be performed by persons
involved in doing the work.
,◉ What are the elements of quality management system? Answer: -
Quality planning
- Quality assurance
- Quality control
◉ What is part of a quality management plan? Answer: - Quality
policy statement
- Quality goals
- Organizational structure with defined roles
◉ What documents support quality control? Answer: - SOPS,
- Concomitant medication log
◉ Quality standards are set by? Answer: - Regulatory bodies
- IRB/IECs
◉ What are the basic steps of risk management? Answer: - Analyze
risk
- Identify risk
- Control risk
◉ Adhering to the principles represented in ALCOA-C support?
Answer: Good documentation practice.
, ◉ What are the correct order of steps CAPA performs? Answer: -
Identify issue
- Determine root cause
- Implement plan for correction
- Assess effectiveness of correction
◉ Having which two people sign and date the consent form is a
quality standard for the informed consent documentation? Answer:
The subject and the person obtaining consent.
◉ True or False. Moving away from preventing problems to
identifying and correcting problems is a key paradigm shift taking
place in clinical trial conduct. Answer: False
◉ True or False. When engaged in quality improvement activities,
it's important to identify who is to blame for quality failure? Answer:
False
◉ What skills are essential for making risk based decision making
successful? Answer: - Quality control skills
- Motivational skills
- Change management skills
