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ACRP CCRA EXAM PREP/STUDY
GUIDE/ QUESTIONS AND ANSWERS
100% PASS/GRADE A+ ASSURED
Questions and Correct Answers
What are expected or possible consequences of over-estimation of
recruitment potential? Ans: — - The trial will overrun its projected
timeline
- The recruitment period will be prolonged and more sites may be
needed
- The study will not have sufficient data within the required
timeframe and will be stopped because of lack of budget
What should be the first consideration when conducting a clinical
trial? Ans: — Subject welfare
When is the investigator allowed to deviate from the protocol?
Ans: — When there is an immediate hazard to a patient.
If the investigator wanted to deviate from the protocol for an
immediate hazard to a patient, according to ICH E6 guidelines who
world they need to report the deviation and rationale to, if
appropriate? Ans: — - The Sponsor
- IRB/IEC
- Regulatory Authorities
Which conditions should be fulfilled when enrolling a subject into
your trial? Ans: — - Subject meets all inclusion criteria
- Subject has given written informed consent
You've been delegated to handle the storage and inventory of IP.
The study drug must be stored below 25C/77F. On a summer
Monday morning you discover that the temperature recording
machine in the storage room has failed so you doin't know what
the temperature has been over the weekend. You check the current
© 2025 All rights reserved
, 2 | Page
temperature; it's 24C/75F. What should you do? Ans: — - Contact
the Sponsor, explain what happened and ask for instructions
- Set up a site staff meeting to conduct a root cause analysis
A protocol amendment was issued for a trial. Your site received
IRB approval for the amendment and wants to implement the
increase in PO dose for your trial subjects as identified in the
amendment trial subjects. As delegated consenting duties you
must re-consent trial subjects before being able to administer the
adjusted dose. You decide to only re-consent trial subjects who are
still taking the IP and not from the subjects woh already
completed their drug intake period. Is this allowed according the
E6 Guideline for GCP? Ans: — No, these subjects are still enrolled
in the trial and therefore need to be updated on any changes to the
protocol.
A trial subject informs you she no longer wants to participant in
the trial. What should your course of action be? Ans: — You ask if
the patient wishes to share the reason why she wants to leave the
trial. If not, you exclude the subject from the trial immediately.
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? Ans: — 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? Ans: — The
principle investigator.
A trial subject suffers from severe repeat headaches. Should this
adverse event be reported to the IRB? Ans: — No
What statements are true concerning an adverse drug reaction?
Ans: — - 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
© 2025 All rights reserved
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What Adverse Events (AEs) are Serious Adverse Events (SAEs)? Ans:
— - 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? Ans: — 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? Ans:
— 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? Ans: — - 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? Ans: — 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
© 2025 All rights reserved
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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? Ans: — 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? Ans: — - An adverse event
- An adverse drug reaction
In regards to AE and ADR reporting, what statements are true?
Ans: — - 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? Ans: — The
investigator
Which term best describes the cyclical process that involves the
Plan, Do, Check, Act activities? Ans: — Quality improvement
Which term best describes an independent assessment of
completed work to ensure it will meet applicable quality
standards? Ans: — Quality assurance
Which term best describes the activities done to ensure quality
output? Ans: — Quality control
Which term requires structure and a definition of acceptable
standards of performance? Ans: — Quality planning
Which is represented in ALCOA-C? Ans: — Attributable
What does CAPA stand for? Ans: — Corrective and Preventive
Action
When not completed correctly, which is a major contributing
factor to an ineffective CAPA plan? Ans: — Root cause analysis
© 2025 All rights reserved
ACRP CCRA EXAM PREP/STUDY
GUIDE/ QUESTIONS AND ANSWERS
100% PASS/GRADE A+ ASSURED
Questions and Correct Answers
What are expected or possible consequences of over-estimation of
recruitment potential? Ans: — - The trial will overrun its projected
timeline
- The recruitment period will be prolonged and more sites may be
needed
- The study will not have sufficient data within the required
timeframe and will be stopped because of lack of budget
What should be the first consideration when conducting a clinical
trial? Ans: — Subject welfare
When is the investigator allowed to deviate from the protocol?
Ans: — When there is an immediate hazard to a patient.
If the investigator wanted to deviate from the protocol for an
immediate hazard to a patient, according to ICH E6 guidelines who
world they need to report the deviation and rationale to, if
appropriate? Ans: — - The Sponsor
- IRB/IEC
- Regulatory Authorities
Which conditions should be fulfilled when enrolling a subject into
your trial? Ans: — - Subject meets all inclusion criteria
- Subject has given written informed consent
You've been delegated to handle the storage and inventory of IP.
The study drug must be stored below 25C/77F. On a summer
Monday morning you discover that the temperature recording
machine in the storage room has failed so you doin't know what
the temperature has been over the weekend. You check the current
© 2025 All rights reserved
, 2 | Page
temperature; it's 24C/75F. What should you do? Ans: — - Contact
the Sponsor, explain what happened and ask for instructions
- Set up a site staff meeting to conduct a root cause analysis
A protocol amendment was issued for a trial. Your site received
IRB approval for the amendment and wants to implement the
increase in PO dose for your trial subjects as identified in the
amendment trial subjects. As delegated consenting duties you
must re-consent trial subjects before being able to administer the
adjusted dose. You decide to only re-consent trial subjects who are
still taking the IP and not from the subjects woh already
completed their drug intake period. Is this allowed according the
E6 Guideline for GCP? Ans: — No, these subjects are still enrolled
in the trial and therefore need to be updated on any changes to the
protocol.
A trial subject informs you she no longer wants to participant in
the trial. What should your course of action be? Ans: — You ask if
the patient wishes to share the reason why she wants to leave the
trial. If not, you exclude the subject from the trial immediately.
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? Ans: — 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? Ans: — The
principle investigator.
A trial subject suffers from severe repeat headaches. Should this
adverse event be reported to the IRB? Ans: — No
What statements are true concerning an adverse drug reaction?
Ans: — - 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
© 2025 All rights reserved
, 3 | Page
What Adverse Events (AEs) are Serious Adverse Events (SAEs)? Ans:
— - 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? Ans: — 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? Ans:
— 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? Ans: — - 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? Ans: — 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
© 2025 All rights reserved
, 4 | Page
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? Ans: — 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? Ans: — - An adverse event
- An adverse drug reaction
In regards to AE and ADR reporting, what statements are true?
Ans: — - 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? Ans: — The
investigator
Which term best describes the cyclical process that involves the
Plan, Do, Check, Act activities? Ans: — Quality improvement
Which term best describes an independent assessment of
completed work to ensure it will meet applicable quality
standards? Ans: — Quality assurance
Which term best describes the activities done to ensure quality
output? Ans: — Quality control
Which term requires structure and a definition of acceptable
standards of performance? Ans: — Quality planning
Which is represented in ALCOA-C? Ans: — Attributable
What does CAPA stand for? Ans: — Corrective and Preventive
Action
When not completed correctly, which is a major contributing
factor to an ineffective CAPA plan? Ans: — Root cause analysis
© 2025 All rights reserved
