ACRP CCRA ACTUAL EXAM PAPER
2026 QUESTIONS WITH ANSWERS
GRADED A+
◍ What are expected or possible consequences of over-estimation of
recruitment potential?.
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?.
Answer: Subject welfare
◍ When is the investigator allowed to deviate from the protocol?.
Answer: When there is an immediate hazard to a patient.
◍ The declaration of Helsinki is primarily addressed to.
Answer: physicians
◍ 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?.
Answer: - The Sponsor- IRB/IEC- Regulatory Authorities
◍ Which conditions should be fulfilled when enrolling a subject into your
trial?.
Answer: - Subject meets all inclusion criteria- Subject has given written
informed consent
◍ what is the declaration of helsinki about.
Answer: the ethical principles for medical research involving human
, subjects
◍ You've been delegated to handle the storage and inventory of I
P. The study drug must be stored below 25C/77
F. 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/75
F. What should you do?.
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?.
Answer: No, these subjects are still enrolled in the trial and therefore need to
be updated on any changes to the protocol.
◍ While the primary purpose of medical research is to generate new
knowledge, this goal can never take precedence over ________.
Answer: the rights and interests of individual research subject
◍ A trial subject informs you she no longer wants to participant in the trial.
What should your course of action be?.
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.
◍ The responsibility for the protection of research subjects must always rest
with the ______ or _____ and never with the research subjects, even though
they have given consent..
Answer: physician or other health care professionals
,◍ 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?.
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?.
Answer: The principle investigator.
◍ Groups that are _____ in medical research should be provided appropriate
access to participation in research.
Answer: underrepresented
◍ A trial subject suffers from severe repeat headaches. Should this adverse
event be reported to the IRB?.
Answer: No
◍ Measures to minimise the ____ must be implemented. The ____ must be
continuously monitored, assessed and documented by the researcher.
Answer: risks
◍ Physicians may not be involved in a research study involving human
subjects unless they are confident that the ___ have been adequately
assessed and can be satisfactorily managed..
Answer: risks
◍ 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
◍ when is research in a vulnerable group justified?.
Answer: if the research is responsive to the health needs or priorities of this
group and the research cannot be carried out in a non-vulnerable group. In
addition, this group should stand to benefit from the knowledge, practices or
interventions that result from the research.
◍ The design and performance of each research study involving human
subjects must be clearly described and justified in a ______.
Answer: research protocol
◍ 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
◍ The protocol should contain a statement of the ____ considerations involved
and should indicate how the ______ have been addressed..
2026 QUESTIONS WITH ANSWERS
GRADED A+
◍ What are expected or possible consequences of over-estimation of
recruitment potential?.
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?.
Answer: Subject welfare
◍ When is the investigator allowed to deviate from the protocol?.
Answer: When there is an immediate hazard to a patient.
◍ The declaration of Helsinki is primarily addressed to.
Answer: physicians
◍ 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?.
Answer: - The Sponsor- IRB/IEC- Regulatory Authorities
◍ Which conditions should be fulfilled when enrolling a subject into your
trial?.
Answer: - Subject meets all inclusion criteria- Subject has given written
informed consent
◍ what is the declaration of helsinki about.
Answer: the ethical principles for medical research involving human
, subjects
◍ You've been delegated to handle the storage and inventory of I
P. The study drug must be stored below 25C/77
F. 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/75
F. What should you do?.
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?.
Answer: No, these subjects are still enrolled in the trial and therefore need to
be updated on any changes to the protocol.
◍ While the primary purpose of medical research is to generate new
knowledge, this goal can never take precedence over ________.
Answer: the rights and interests of individual research subject
◍ A trial subject informs you she no longer wants to participant in the trial.
What should your course of action be?.
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.
◍ The responsibility for the protection of research subjects must always rest
with the ______ or _____ and never with the research subjects, even though
they have given consent..
Answer: physician or other health care professionals
,◍ 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?.
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?.
Answer: The principle investigator.
◍ Groups that are _____ in medical research should be provided appropriate
access to participation in research.
Answer: underrepresented
◍ A trial subject suffers from severe repeat headaches. Should this adverse
event be reported to the IRB?.
Answer: No
◍ Measures to minimise the ____ must be implemented. The ____ must be
continuously monitored, assessed and documented by the researcher.
Answer: risks
◍ Physicians may not be involved in a research study involving human
subjects unless they are confident that the ___ have been adequately
assessed and can be satisfactorily managed..
Answer: risks
◍ 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
◍ when is research in a vulnerable group justified?.
Answer: if the research is responsive to the health needs or priorities of this
group and the research cannot be carried out in a non-vulnerable group. In
addition, this group should stand to benefit from the knowledge, practices or
interventions that result from the research.
◍ The design and performance of each research study involving human
subjects must be clearly described and justified in a ______.
Answer: research protocol
◍ 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
◍ The protocol should contain a statement of the ____ considerations involved
and should indicate how the ______ have been addressed..
