ACRP CCRA PRACTICE EXAMS ANSWERS AND
QUESTIONS SET A+
✔✔During a visit with investigator, a subject reported feeling heart palpitations for a
brief period of time during the previous evening. The heart palpitations resolved without
reoccurrence. The investigator considered these symptoms to be unrelated to study
drug. The next day, the subject told a fellow student that he felt tired and was planning
on taking a nap. Later, the subject was found dead. A preliminary report from the
medical examiner indicated the subject died of pulmonary embolism. What should your
next course of action be? - ✔✔- Record these events in case report form
- Immediately notify sponsor about serious adverse events
✔✔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? -
✔✔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? - ✔✔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? - ✔✔- An
adverse event
- An adverse drug reaction
✔✔In regards to AE and ADR reporting, what statements are true? - ✔✔- 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? - ✔✔The investigator
✔✔Which term best describes the cyclical process that involves the Plan, Do, Check,
Act activities? - ✔✔Quality improvement
✔✔Which term best describes an independent assessment of completed work to
ensure it will meet applicable quality standards? - ✔✔Quality assurance
✔✔Which term best describes the activities done to ensure quality output? - ✔✔Quality
control
✔✔Which term requires structure and a definition of acceptable standards of
performance? - ✔✔Quality planning
✔✔Which is represented in ALCOA-C? - ✔✔Attributable
✔✔What does CAPA stand for? - ✔✔Corrective and Preventive Action
✔✔When not completed correctly, which is a major contributing factor to an ineffective
CAPA plan? - ✔✔Root cause analysis
✔✔What are the cyclical activities performed a part of quality improvement? - ✔✔Plan,
Do, Check, Act
✔✔What is sued to determine root causes? - ✔✔- Fishbone diagram
- Process flow charts
- The 5 Whys
✔✔What are fishbone diagrams, process flow charts, and the 5 whys used for
determining? - ✔✔Root causes
✔✔What is the key difference between quality improvement and quality assurance
activities? - ✔✔Can be performed by persons involved in doing the work.
✔✔What are the elements of quality management system? - ✔✔- Quality planning
- Quality assurance
- Quality control
✔✔What is part of a quality management plan? - ✔✔- Quality policy statement
- Quality goals
- Organizational structure with defined roles
, ✔✔What documents support quality control? - ✔✔- SOPS,
- Concomitant medication log
✔✔Quality standards are set by? - ✔✔- Regulatory bodies
- IRB/IECs
✔✔What are the basic steps of risk management? - ✔✔- Analyze risk
- Identify risk
- Control risk
✔✔Adhering to the principles represented in ALCOA-C support? - ✔✔Good
documentation practice.
✔✔What are the correct order of steps CAPA performs? - ✔✔- 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? - ✔✔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. - ✔✔False
✔✔True or False. When engaged in quality improvement activities, it's important to
identify who is to blame for quality failure? - ✔✔False
✔✔What skills are essential for making risk based decision making successful? - ✔✔-
Quality control skills
- Motivational skills
- Change management skills
✔✔What are steps in risk assessment? - ✔✔- 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? - ✔✔Insufficient IP accountability.
✔✔When practicing RBDM in clinical research, what should be the primary focus? -
✔✔Subject safety and quality of the data.
QUESTIONS SET A+
✔✔During a visit with investigator, a subject reported feeling heart palpitations for a
brief period of time during the previous evening. The heart palpitations resolved without
reoccurrence. The investigator considered these symptoms to be unrelated to study
drug. The next day, the subject told a fellow student that he felt tired and was planning
on taking a nap. Later, the subject was found dead. A preliminary report from the
medical examiner indicated the subject died of pulmonary embolism. What should your
next course of action be? - ✔✔- Record these events in case report form
- Immediately notify sponsor about serious adverse events
✔✔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? -
✔✔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? - ✔✔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? - ✔✔- An
adverse event
- An adverse drug reaction
✔✔In regards to AE and ADR reporting, what statements are true? - ✔✔- 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? - ✔✔The investigator
✔✔Which term best describes the cyclical process that involves the Plan, Do, Check,
Act activities? - ✔✔Quality improvement
✔✔Which term best describes an independent assessment of completed work to
ensure it will meet applicable quality standards? - ✔✔Quality assurance
✔✔Which term best describes the activities done to ensure quality output? - ✔✔Quality
control
✔✔Which term requires structure and a definition of acceptable standards of
performance? - ✔✔Quality planning
✔✔Which is represented in ALCOA-C? - ✔✔Attributable
✔✔What does CAPA stand for? - ✔✔Corrective and Preventive Action
✔✔When not completed correctly, which is a major contributing factor to an ineffective
CAPA plan? - ✔✔Root cause analysis
✔✔What are the cyclical activities performed a part of quality improvement? - ✔✔Plan,
Do, Check, Act
✔✔What is sued to determine root causes? - ✔✔- Fishbone diagram
- Process flow charts
- The 5 Whys
✔✔What are fishbone diagrams, process flow charts, and the 5 whys used for
determining? - ✔✔Root causes
✔✔What is the key difference between quality improvement and quality assurance
activities? - ✔✔Can be performed by persons involved in doing the work.
✔✔What are the elements of quality management system? - ✔✔- Quality planning
- Quality assurance
- Quality control
✔✔What is part of a quality management plan? - ✔✔- Quality policy statement
- Quality goals
- Organizational structure with defined roles
, ✔✔What documents support quality control? - ✔✔- SOPS,
- Concomitant medication log
✔✔Quality standards are set by? - ✔✔- Regulatory bodies
- IRB/IECs
✔✔What are the basic steps of risk management? - ✔✔- Analyze risk
- Identify risk
- Control risk
✔✔Adhering to the principles represented in ALCOA-C support? - ✔✔Good
documentation practice.
✔✔What are the correct order of steps CAPA performs? - ✔✔- 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? - ✔✔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. - ✔✔False
✔✔True or False. When engaged in quality improvement activities, it's important to
identify who is to blame for quality failure? - ✔✔False
✔✔What skills are essential for making risk based decision making successful? - ✔✔-
Quality control skills
- Motivational skills
- Change management skills
✔✔What are steps in risk assessment? - ✔✔- 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? - ✔✔Insufficient IP accountability.
✔✔When practicing RBDM in clinical research, what should be the primary focus? -
✔✔Subject safety and quality of the data.
