ACRP CCRC Exam review; questions with
100%- correct answers; verified; latest
update
When asked by a regulatory body why they received SAE related information on
12/2013 from an incident that occurred in 5/2013, the sponsor explained the reason
being they received the trial related SAE information from the investigator in
12/2013. Is the sponsor correct in only holding the investigator accountable for
their late reporting? - ANSWER -No, the sponsor should support the conduct QC
activities with the sites to help them ensure timely SAE reporting.
A trial subject in a cardiology trial is admitted to hospital with heart attack. The
investigator considers this event possibly related to the study drug even though this
is not listed in the IB as a potential adverse reaction. What would the investigator
report this event to the sponsor as? - ANSWER -An unexpected, serious adverse
event
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
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
What are steps in risk assessment? - 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? - ANSWER -Insufficient IP accountability.
When practicing RBDM in clinical research, what should be the primary focus? -
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? - ANSWER -- The likelihood of occurrence
- The consequences of the occurrence
When assessing the seriousness of a risk, what should the risk be compared to? -
ANSWER -Standard clinical practice.
What is essential to keep in mind when determining actions to mitigate potential
risks? - ANSWER -The make a risk-based decision following a risk management
plan.
Where should potential risks be documented? - ANSWER -A risk management
plan.
What skills are most affected by the introduction of risk-based decision making? -
ANSWER -- Motivational skills
- Change management
100%- correct answers; verified; latest
update
When asked by a regulatory body why they received SAE related information on
12/2013 from an incident that occurred in 5/2013, the sponsor explained the reason
being they received the trial related SAE information from the investigator in
12/2013. Is the sponsor correct in only holding the investigator accountable for
their late reporting? - ANSWER -No, the sponsor should support the conduct QC
activities with the sites to help them ensure timely SAE reporting.
A trial subject in a cardiology trial is admitted to hospital with heart attack. The
investigator considers this event possibly related to the study drug even though this
is not listed in the IB as a potential adverse reaction. What would the investigator
report this event to the sponsor as? - ANSWER -An unexpected, serious adverse
event
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
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
What are steps in risk assessment? - 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? - ANSWER -Insufficient IP accountability.
When practicing RBDM in clinical research, what should be the primary focus? -
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? - ANSWER -- The likelihood of occurrence
- The consequences of the occurrence
When assessing the seriousness of a risk, what should the risk be compared to? -
ANSWER -Standard clinical practice.
What is essential to keep in mind when determining actions to mitigate potential
risks? - ANSWER -The make a risk-based decision following a risk management
plan.
Where should potential risks be documented? - ANSWER -A risk management
plan.
What skills are most affected by the introduction of risk-based decision making? -
ANSWER -- Motivational skills
- Change management
