ACRP CCRC EXAM PREP EXAM
STUDYGUIDE EXAM WITH CORRECT
ACTUAL QUESTIONS AND CORRECTLY
WELL DEFINED ANSWERS LATEST
ALREADY GRADED A+
What does CAPA stand for? - ANSWERS-Corrective and
Preventive Action
When not completed correctly, which is a major
contributing factor to an ineffective CAPA plan? - ANSWERS-
Root cause analysis
What are the cyclical activities performed a part of quality
improvement? - ANSWERS-Plan, Do, Check, Act
What is sued to determine root causes? - ANSWERS--
Fishbone diagram
- Process flow charts
- The 5 Whys
,What are fishbone diagrams, process flow charts, and the 5
whys used for determining? - ANSWERS-Root causes
What is the key difference between quality improvement
and quality assurance activities? - ANSWERS-Can be
performed by persons involved in doing the work.
What are the elements of quality management system? -
ANSWERS-- Quality planning
- Quality assurance
- Quality control
What is part of a quality management plan? - ANSWERS--
Quality policy statement
- Quality goals
- Organizational structure with defined roles
What documents support quality control? - ANSWERS--
SOPS,
- Concomitant medication log
,Quality standards are set by? - ANSWERS-- Regulatory
bodies
- IRB/IECs
What are the basic steps of risk management? - ANSWERS--
Analyze risk
- Identify risk
- Control risk
Adhering to the principles represented in ALCOA-C support?
- ANSWERS-Good documentation practice.
What are the correct order of steps CAPA performs? -
ANSWERS-- 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? - ANSWERS-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. - ANSWERS-False
True or False. When engaged in quality improvement
activities, it's important to identify who is to blame for
quality failure? - ANSWERS-False
What skills are essential for making risk based decision
making successful? - ANSWERS-- Quality control skills
- Motivational skills
- Change management skills
What are steps in risk assessment? - ANSWERS-- Identifying
the consequences of risks occurring
- Categorizing risks
- Identifying risks
What risk should be appointed highest priority to manage in
view of patient safety and data quality? - ANSWERS-
Insufficient IP accountability.
STUDYGUIDE EXAM WITH CORRECT
ACTUAL QUESTIONS AND CORRECTLY
WELL DEFINED ANSWERS LATEST
ALREADY GRADED A+
What does CAPA stand for? - ANSWERS-Corrective and
Preventive Action
When not completed correctly, which is a major
contributing factor to an ineffective CAPA plan? - ANSWERS-
Root cause analysis
What are the cyclical activities performed a part of quality
improvement? - ANSWERS-Plan, Do, Check, Act
What is sued to determine root causes? - ANSWERS--
Fishbone diagram
- Process flow charts
- The 5 Whys
,What are fishbone diagrams, process flow charts, and the 5
whys used for determining? - ANSWERS-Root causes
What is the key difference between quality improvement
and quality assurance activities? - ANSWERS-Can be
performed by persons involved in doing the work.
What are the elements of quality management system? -
ANSWERS-- Quality planning
- Quality assurance
- Quality control
What is part of a quality management plan? - ANSWERS--
Quality policy statement
- Quality goals
- Organizational structure with defined roles
What documents support quality control? - ANSWERS--
SOPS,
- Concomitant medication log
,Quality standards are set by? - ANSWERS-- Regulatory
bodies
- IRB/IECs
What are the basic steps of risk management? - ANSWERS--
Analyze risk
- Identify risk
- Control risk
Adhering to the principles represented in ALCOA-C support?
- ANSWERS-Good documentation practice.
What are the correct order of steps CAPA performs? -
ANSWERS-- 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? - ANSWERS-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. - ANSWERS-False
True or False. When engaged in quality improvement
activities, it's important to identify who is to blame for
quality failure? - ANSWERS-False
What skills are essential for making risk based decision
making successful? - ANSWERS-- Quality control skills
- Motivational skills
- Change management skills
What are steps in risk assessment? - ANSWERS-- Identifying
the consequences of risks occurring
- Categorizing risks
- Identifying risks
What risk should be appointed highest priority to manage in
view of patient safety and data quality? - ANSWERS-
Insufficient IP accountability.
