ACRP CCRA EXAM 2026 EXAM SCRIPT WITH
VERIFIED SOLUTIONS
◉ What statements are true concerning an adverse drug reaction?
Answer: - 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)?
Answer: - 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? Answer: 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?
Answer: 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? Answer: - 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? 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
VERIFIED SOLUTIONS
◉ What statements are true concerning an adverse drug reaction?
Answer: - 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)?
Answer: - 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? Answer: 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?
Answer: 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? Answer: - 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? 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
