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SOCRA CCRP Competency study guide Exam test questions with approved Answers 2024/2025 $11.99
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SOCRA CCRP Competency study guide Exam test questions with approved Answers 2024/2025
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SOCRA CCRP Competency study guide Exam test questions with approved Answers 2024/2025 What determines the causality of an adverse event? - correct answer The investigator Which term best describes the cyclical process that involves the Plan, Do, Check, Act activities? - correct answer Quality...

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  • November 5, 2024
  • 48
  • 2024/2025
  • Exam (elaborations)
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SOCRA CCRP Competency study guide Exam
test questions with approved Answers
2024/2025

What determines the causality of an adverse event? - correct
answer The investigator


Which term best describes the cyclical process that involves the
Plan, Do, Check, Act activities? - correct answer Quality
improvement


Which term best describes an independent assessment of
completed work to ensure it will meet applicable quality
standards? - correct answer Quality assurance


Which term best describes the activities done to ensure quality
output? - correct answer Quality control


Which term requires structure and a definition of acceptable
standards of performance? - correct answer Quality planning


Which is represented in ALCOA-C? - correct answer
Attributable


What does CAPA stand for? - correct answer Corrective and
Preventive Action

,When not completed correctly, which is a major contributing
factor to an ineffective CAPA plan? - correct answer Root cause
analysis


What are the cyclical activities performed a part of quality
improvement? - correct answer Plan, Do, Check, Act


What is sued to determine root causes? - correct answer -
Fishbone diagram
- Process flow charts
- The 5 Whys


What are fishbone diagrams, process flow charts, and the 5 whys
used for determining? - correct answer Root causes


What is the key difference between quality improvement and
quality assurance activities? - correct answer Can be performed
by persons involved in doing the work.


What are the elements of quality management system? - correct
answer - Quality planning
- Quality assurance
- Quality control


What is part of a quality management plan? - correct answer -
Quality policy statement
- Quality goals
- Organizational structure with defined roles

,What documents support quality control? - correct answer -
SOPS,
- Concomitant medication log


Quality standards are set by? - correct answer - Regulatory
bodies
- IRB/IECs


What are the basic steps of risk management? - correct answer
- Analyze risk
- Identify risk
- Control risk


Adhering to the principles represented in ALCOA-C support? -
correct answer Good documentation practice.


What are the correct order of steps CAPA performs? - correct
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? -
correct 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. - correct answer False


True or False. When engaged in quality improvement activities,
it's important to identify who is to blame for quality failure? -
correct answer False


What skills are essential for making risk based decision making
successful? - correct answer - Quality control skills
- Motivational skills
- Change management skills


What are steps in risk assessment? - correct answer -
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? - correct answer Insufficient
IP accountability.


When practicing RBDM in clinical research, what should be the
primary focus? - correct answer Subject safety and quality of
the data.


When assessing the seriousness of a risk, what are the primary
considerations that need to be taken into account? - correct
answer - The likelihood of occurrence

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