2025 ACRP CCRC EXAM PREP 300 QUESTIONS AND
CORRECT DETAILED ANSWERS (100% CORRECT
ANSWERS) ACRP CCRC EXAM PRACTICE QS AND
AS (NEWEST!) MOST TESTED QUESTIONS
THIS RESOURCE PROVIDES PRACTICE QUESTIONS DESIGNED TO STRENGTHEN KNOWLEDGE
OF GOOD CLINICAL PRACTICE (GCP), INVESTIGATOR RESPONSIBILITIES, SUBJECT
MANAGEMENT, AND REGULATORY COMPLIANCE IN CLINICAL RESEARCH. SCENARIOS COVER
PROTOCOL DEVIATIONS, INFORMED CONSENT, INVESTIGATIONAL PRODUCT HANDLING,
AND ETHICAL CONSIDERATIONS. IT IS IDEAL FOR CLINICAL RESEARCH PROFESSIONALS AND
STUDENTS PREPARING FOR GCP CERTIFICATION OR ACTIVE TRIAL PARTICIPATION.
What are expected or possible consequences of over-estimation of recruitment potential? -
CORRECT ANSWER-- 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? - CORRECT ANSWER-
Subject welfare
When is the investigator allowed to deviate from the protocol? - CORRECT ANSWER-When
there is an immediate hazard to a patient.
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 temperature; it's 24C/75F. What should you do? - CORRECT
ANSWER-- 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? - CORRECT ANSWER-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? - CORRECT ANSWER-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? - CORRECT ANSWER-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? - CORRECT ANSWER-The principle
investigator.
A trial subject suffers from severe repeat headaches. Should this adverse event be reported to the
IRB? - CORRECT ANSWER-No
What statements are true concerning an adverse drug reaction? - CORRECT 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)? - CORRECT 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? -
CORRECT 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? - CORRECT 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? - CORRECT 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? - CORRECT 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? -
CORRECT 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? - CORRECT ANSWER-- An adverse event
- An adverse drug reaction
In regards to AE and ADR reporting, what statements are true? - CORRECT 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? - CORRECT ANSWER-The investigator
Which term best describes the cyclical process that involves the Plan, Do, Check, Act activities? -
CORRECT ANSWER-Quality improvement
Which term best describes an independent assessment of completed work to ensure it will meet
applicable quality standards? - CORRECT ANSWER-Quality assurance
Which term best describes the activities done to ensure quality output? - CORRECT ANSWER-
Quality control
Which term requires structure and a definition of acceptable standards of performance? -
CORRECT ANSWER-Quality planning
Which is represented in ALCOA-C? - CORRECT ANSWER-Attributable
What does CAPA stand for? - CORRECT ANSWER-Corrective and Preventive Action
When not completed correctly, which is a major contributing factor to an ineffective CAPA plan? -
CORRECT ANSWER-Root cause analysis
What are the cyclical activities performed a part of quality improvement? - CORRECT ANSWER-
Plan, Do, Check, Act
What is sued to determine root causes? - CORRECT ANSWER-- Fishbone diagram
- Process flow charts
- The 5 Whys
What are fishbone diagrams, process flow charts, and the 5 whys used for determining? -
CORRECT ANSWER-Root causes
CORRECT DETAILED ANSWERS (100% CORRECT
ANSWERS) ACRP CCRC EXAM PRACTICE QS AND
AS (NEWEST!) MOST TESTED QUESTIONS
THIS RESOURCE PROVIDES PRACTICE QUESTIONS DESIGNED TO STRENGTHEN KNOWLEDGE
OF GOOD CLINICAL PRACTICE (GCP), INVESTIGATOR RESPONSIBILITIES, SUBJECT
MANAGEMENT, AND REGULATORY COMPLIANCE IN CLINICAL RESEARCH. SCENARIOS COVER
PROTOCOL DEVIATIONS, INFORMED CONSENT, INVESTIGATIONAL PRODUCT HANDLING,
AND ETHICAL CONSIDERATIONS. IT IS IDEAL FOR CLINICAL RESEARCH PROFESSIONALS AND
STUDENTS PREPARING FOR GCP CERTIFICATION OR ACTIVE TRIAL PARTICIPATION.
What are expected or possible consequences of over-estimation of recruitment potential? -
CORRECT ANSWER-- 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? - CORRECT ANSWER-
Subject welfare
When is the investigator allowed to deviate from the protocol? - CORRECT ANSWER-When
there is an immediate hazard to a patient.
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 temperature; it's 24C/75F. What should you do? - CORRECT
ANSWER-- 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? - CORRECT ANSWER-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? - CORRECT ANSWER-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? - CORRECT ANSWER-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? - CORRECT ANSWER-The principle
investigator.
A trial subject suffers from severe repeat headaches. Should this adverse event be reported to the
IRB? - CORRECT ANSWER-No
What statements are true concerning an adverse drug reaction? - CORRECT 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)? - CORRECT 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? -
CORRECT 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? - CORRECT 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? - CORRECT 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? - CORRECT 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? -
CORRECT 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? - CORRECT ANSWER-- An adverse event
- An adverse drug reaction
In regards to AE and ADR reporting, what statements are true? - CORRECT 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? - CORRECT ANSWER-The investigator
Which term best describes the cyclical process that involves the Plan, Do, Check, Act activities? -
CORRECT ANSWER-Quality improvement
Which term best describes an independent assessment of completed work to ensure it will meet
applicable quality standards? - CORRECT ANSWER-Quality assurance
Which term best describes the activities done to ensure quality output? - CORRECT ANSWER-
Quality control
Which term requires structure and a definition of acceptable standards of performance? -
CORRECT ANSWER-Quality planning
Which is represented in ALCOA-C? - CORRECT ANSWER-Attributable
What does CAPA stand for? - CORRECT ANSWER-Corrective and Preventive Action
When not completed correctly, which is a major contributing factor to an ineffective CAPA plan? -
CORRECT ANSWER-Root cause analysis
What are the cyclical activities performed a part of quality improvement? - CORRECT ANSWER-
Plan, Do, Check, Act
What is sued to determine root causes? - CORRECT ANSWER-- Fishbone diagram
- Process flow charts
- The 5 Whys
What are fishbone diagrams, process flow charts, and the 5 whys used for determining? -
CORRECT ANSWER-Root causes
