ACRP CCRC ccrcPRACTICE EXAM 2024
QUESTIONS AND ANSWERS/ ACRP PRACTICE
EXAM 2024-2025 QUESTIONS AND ANSWERS
A 22y/o male was entered into a clinical study for treatment of schizophrenia The
study drug was administered orally, BID. One week later, the subject visited the
investigator complaining of sever sore throat. The IB lists this as an occurrence
reported by 1% of subjects receiving drug. How should this severe throat be
classified? - Answer - An adverse event
- An adverse drug reaction
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
QUESTIONS AND ANSWERS/ ACRP PRACTICE
EXAM 2024-2025 QUESTIONS AND ANSWERS
A 22y/o male was entered into a clinical study for treatment of schizophrenia The
study drug was administered orally, BID. One week later, the subject visited the
investigator complaining of sever sore throat. The IB lists this as an occurrence
reported by 1% of subjects receiving drug. How should this severe throat be
classified? - Answer - An adverse event
- An adverse drug reaction
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
