ACRP CCRC Exam Prep Questions (Latest 2023 – 2024)
With Verified Answers
ACRP CCRC Exam Prep Questions (Latest 2023 – 2024)
With Verified Answers
A patient cannot recall the name of the heart condition medication he took a few years ago.
This is important information for deciding whether the patient may be enrolled in a clinical
trial (IC/EC). What's your best course of action? - You attempt to retrieve the patients
medical history by contacting previous caregivers and you wait for additional information
before enrollment.
Who has ultimate trial responsibility for each subject? - The principle investigator.
A trial subject suffers from severe repeat headaches. Should this adverse event be reported
to the IRB? - No
What statements are true concerning an adverse drug reaction? - - All noxious and
unintended responses to a medicinal product related to any dose should be considered as
an ADR
- An ADR suggests a relationship to trail medication
- All ADRs must be documented
What Adverse Events (AEs) are Serious Adverse Events (SAEs)? - - Any AE that results in
death
- Any AE that results in inpatient hospitalization
- Any AE that is a congenital anomaly
During a study visit a patient tells the investigator that she visited an emergency room and
received intensive treatment for allergic bronchospasm. Since the patient was in the
emergency room for only three hours, the investigator did not assess the event as serious.
Is this a correct assessment? - No, this would be a medically important event and should be
considered serious
What data points minimally need to be reported by the site when reporting an SAE, so that
the sponsor can process the event? - Identification of event, product, and trial subject
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
With Verified Answers
ACRP CCRC Exam Prep Questions (Latest 2023 – 2024)
With Verified Answers
A patient cannot recall the name of the heart condition medication he took a few years ago.
This is important information for deciding whether the patient may be enrolled in a clinical
trial (IC/EC). What's your best course of action? - You attempt to retrieve the patients
medical history by contacting previous caregivers and you wait for additional information
before enrollment.
Who has ultimate trial responsibility for each subject? - The principle investigator.
A trial subject suffers from severe repeat headaches. Should this adverse event be reported
to the IRB? - No
What statements are true concerning an adverse drug reaction? - - All noxious and
unintended responses to a medicinal product related to any dose should be considered as
an ADR
- An ADR suggests a relationship to trail medication
- All ADRs must be documented
What Adverse Events (AEs) are Serious Adverse Events (SAEs)? - - Any AE that results in
death
- Any AE that results in inpatient hospitalization
- Any AE that is a congenital anomaly
During a study visit a patient tells the investigator that she visited an emergency room and
received intensive treatment for allergic bronchospasm. Since the patient was in the
emergency room for only three hours, the investigator did not assess the event as serious.
Is this a correct assessment? - No, this would be a medically important event and should be
considered serious
What data points minimally need to be reported by the site when reporting an SAE, so that
the sponsor can process the event? - Identification of event, product, and trial subject
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
