2026 ACRP-CP Exam practice questions and verified answers
with complete solutions.
What is an ADR? - ANSWER: Adverse drug reaction (ADR)
1.Pre-approval clinical experience with a new medicinal product or its new usages:
all noxious and unintended responses to a medicinal product related to any dose
should be considered adverse drug reactions. The phrase responses to a medicinal
product means that a causal relationship between a medicinal product and an
adverse event is at least a reasonable possibility, i.e., the relationship cannot be
ruled out.
2. Regarding marketed medicinal products: a response to a drug which is noxious
and unintended and which occurs at doses normally used in man for prophylaxis,
diagnosis, or therapy of diseases or for modification of physiological function.
What is an AE? - ANSWER: Adverse event (AE)
1. Any untoward medical occurrence in a patient or clinical investigation subject
administered a pharmaceutical product and which does not necessarily have a
causal relationship with this treatment. An adverse event (AE) can therefore be any
unfavourable and unintended sign (including an abnormal laboratory finding),
symptom, or disease temporally associated with the use of a medicinal
(investigational) product, whether or not related to the medicinal (investigational)
product.
What is an SAE? - ANSWER: Serious adverse event (SAE)
1. Results in death
2. Is life-threatening
3. Requires inpatient hospitalization or prolongation of existing hospitalization
4. Results in persistent or significant disability/incapacity
5. Is a congenital anomaly/birth defect
What is an UADR? - ANSWER: Unexpected adverse drug reaction (UADR)
1. An adverse reaction, the nature or severity of which is not consistent with the
applicable product information (e.g., IB for an unapproved IP or package
insert/summary of product characteristics for an approved product)
Who constitutes a vulnerable subject? - ANSWER: Individuals whose willingness to
volunteer in a clinical trial may be unduly influenced by the expectation of benefits
associated with participation, or of a retaliatory response from senior members of
a hierarchy in case of refusal to participate.
Examples are members of a group with a hierarchical structure, such as medical,
pharmacy, dental, and nursing students, subordinate hospital and laboratory
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,personnel, employees of the pharmaceutical industry, members of the armed
forces, and persons kept in detention.
Other vulnerable subjects include patients with incurable diseases, persons in
nursing homes, unemployed or impoverished persons, patients in emergency
situations, ethnic minority groups, homeless persons, nomads, refugees, minors,
and those incapable of giving consent.
GCP: Clinical trials should be conducted in accordance with the ethical principles
that have their origin in the ___________ __ ________, and that are consistent with GCP
and the applicable regulatory requirement(s). - ANSWER: Declaration of Helsinki
GCP: What is beneficence? - ANSWER: The idea that foreseeable risks and
inconveniences should be weighed against the anticipated benefit for the individual
trial subject and society. A trial should be initiated and continued only if the
anticipated benefits justify the risks.
GCP: What are the most important considerations in clinical trials? And should thus
prevail over interests of science and society? - ANSWER: The rights, safety, and
well-being of the trial subjects.
GCP: What qualifies an individual to conduct, or work on, a clinical trial? - ANSWER:
Education, training, and experience to perform his or her task(s).
GCP: What should be obtained from every subject prior to clinical trial participation?
- ANSWER: Freely given informed consent.
What is the purpose of the IRB/IEC? - ANSWER: An IRB/IEC should safeguard the
rights, safety, and well-being of all trial subjects. Special attention should be paid to
trials that may include vulnerable subjects.
How frequently should the IRB/IEC conduct a CR of each ongoing trial? - ANSWER:
The IRB/IEC should conduct continuing review of each ongoing trial at intervals
appropriate to the degree of risk to human subjects, but at least once per year.
What is the minimum number of members for an IRB/IEC? And what specific people
need to be involved? - ANSWER: (a) At least five members.
(b) At least one member whose primary area of interest is in a nonscientific area.
(c) At least one member who is independent of the institution/trial site.
What four things should the investigator promptly report to the IRB/IEC? - ANSWER:
(a) Deviations from, or changes of, the protocol to eliminate immediate hazards to
the trial subjects.
(b) Changes increasing the risk to subjects and/or affecting significantly the
conduct of the trial.
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, (c) All adverse drug reactions (ADRs) that are both serious and unexpected.
(d) New information that may affect adversely the safety of the subjects or the
conduct of the trial.
For how long should the IRB/IEC retain all relevant records? - ANSWER: The
IRB/IEC should retain all relevant records for a period of at least 3-years after
completion of the trial and make them available upon request from the regulatory
authority(ies).
Who is ultimately responsible for the investigational product accountability at the
site? - ANSWER: The investigator.
What records should be maintained regarding investigational product? - ANSWER:
The investigator or pharmacist or other appropriate individual, who is designated by
the investigator/institution, should maintain records of the product's delivery to the
trial site, the inventory at the site, the use by each subject, and the return to the
sponsor or alternative disposition of unused product(s). These records should
include dates, quantities, batch/serial numbers, expiration dates (if applicable), and
the unique code numbers assigned to the investigational product(s) and trial
subjects. Investigators should maintain records that document adequately that the
subjects were provided the doses specified by the protocol and reconcile all
investigational product(s) received from the sponsor.
Who should explain the correct use of the investigational product to each subject? -
ANSWER: The investigator, or a person designated by the investigator/institution,
should explain the correct use of the investigational product(s) to each subject and
should check, at intervals appropriate for the trial, that each subject is following the
instructions properly.
Can the ICF include language that causes the subject to waive any legal rights? -
ANSWER: None of the oral and written information concerning the trial, including
the written informed consent form, should contain any language that causes the
subject or the subject's legally acceptable representative to waive or to appear to
waive any legal rights, or that releases or appears to release the investigator, the
institution, the sponsor, or their agents from liability for negligence.
What twenty items need to be included in the ICF and its discussion? - ANSWER: (a)
That the trial involves research.
(b) The purpose of the trial.
(c) The trial treatment(s) and the probability for random assignment to each
treatment.
(d) The trial procedures to be followed, including all invasive procedures.
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with complete solutions.
What is an ADR? - ANSWER: Adverse drug reaction (ADR)
1.Pre-approval clinical experience with a new medicinal product or its new usages:
all noxious and unintended responses to a medicinal product related to any dose
should be considered adverse drug reactions. The phrase responses to a medicinal
product means that a causal relationship between a medicinal product and an
adverse event is at least a reasonable possibility, i.e., the relationship cannot be
ruled out.
2. Regarding marketed medicinal products: a response to a drug which is noxious
and unintended and which occurs at doses normally used in man for prophylaxis,
diagnosis, or therapy of diseases or for modification of physiological function.
What is an AE? - ANSWER: Adverse event (AE)
1. Any untoward medical occurrence in a patient or clinical investigation subject
administered a pharmaceutical product and which does not necessarily have a
causal relationship with this treatment. An adverse event (AE) can therefore be any
unfavourable and unintended sign (including an abnormal laboratory finding),
symptom, or disease temporally associated with the use of a medicinal
(investigational) product, whether or not related to the medicinal (investigational)
product.
What is an SAE? - ANSWER: Serious adverse event (SAE)
1. Results in death
2. Is life-threatening
3. Requires inpatient hospitalization or prolongation of existing hospitalization
4. Results in persistent or significant disability/incapacity
5. Is a congenital anomaly/birth defect
What is an UADR? - ANSWER: Unexpected adverse drug reaction (UADR)
1. An adverse reaction, the nature or severity of which is not consistent with the
applicable product information (e.g., IB for an unapproved IP or package
insert/summary of product characteristics for an approved product)
Who constitutes a vulnerable subject? - ANSWER: Individuals whose willingness to
volunteer in a clinical trial may be unduly influenced by the expectation of benefits
associated with participation, or of a retaliatory response from senior members of
a hierarchy in case of refusal to participate.
Examples are members of a group with a hierarchical structure, such as medical,
pharmacy, dental, and nursing students, subordinate hospital and laboratory
1|Page
,personnel, employees of the pharmaceutical industry, members of the armed
forces, and persons kept in detention.
Other vulnerable subjects include patients with incurable diseases, persons in
nursing homes, unemployed or impoverished persons, patients in emergency
situations, ethnic minority groups, homeless persons, nomads, refugees, minors,
and those incapable of giving consent.
GCP: Clinical trials should be conducted in accordance with the ethical principles
that have their origin in the ___________ __ ________, and that are consistent with GCP
and the applicable regulatory requirement(s). - ANSWER: Declaration of Helsinki
GCP: What is beneficence? - ANSWER: The idea that foreseeable risks and
inconveniences should be weighed against the anticipated benefit for the individual
trial subject and society. A trial should be initiated and continued only if the
anticipated benefits justify the risks.
GCP: What are the most important considerations in clinical trials? And should thus
prevail over interests of science and society? - ANSWER: The rights, safety, and
well-being of the trial subjects.
GCP: What qualifies an individual to conduct, or work on, a clinical trial? - ANSWER:
Education, training, and experience to perform his or her task(s).
GCP: What should be obtained from every subject prior to clinical trial participation?
- ANSWER: Freely given informed consent.
What is the purpose of the IRB/IEC? - ANSWER: An IRB/IEC should safeguard the
rights, safety, and well-being of all trial subjects. Special attention should be paid to
trials that may include vulnerable subjects.
How frequently should the IRB/IEC conduct a CR of each ongoing trial? - ANSWER:
The IRB/IEC should conduct continuing review of each ongoing trial at intervals
appropriate to the degree of risk to human subjects, but at least once per year.
What is the minimum number of members for an IRB/IEC? And what specific people
need to be involved? - ANSWER: (a) At least five members.
(b) At least one member whose primary area of interest is in a nonscientific area.
(c) At least one member who is independent of the institution/trial site.
What four things should the investigator promptly report to the IRB/IEC? - ANSWER:
(a) Deviations from, or changes of, the protocol to eliminate immediate hazards to
the trial subjects.
(b) Changes increasing the risk to subjects and/or affecting significantly the
conduct of the trial.
2|Page
, (c) All adverse drug reactions (ADRs) that are both serious and unexpected.
(d) New information that may affect adversely the safety of the subjects or the
conduct of the trial.
For how long should the IRB/IEC retain all relevant records? - ANSWER: The
IRB/IEC should retain all relevant records for a period of at least 3-years after
completion of the trial and make them available upon request from the regulatory
authority(ies).
Who is ultimately responsible for the investigational product accountability at the
site? - ANSWER: The investigator.
What records should be maintained regarding investigational product? - ANSWER:
The investigator or pharmacist or other appropriate individual, who is designated by
the investigator/institution, should maintain records of the product's delivery to the
trial site, the inventory at the site, the use by each subject, and the return to the
sponsor or alternative disposition of unused product(s). These records should
include dates, quantities, batch/serial numbers, expiration dates (if applicable), and
the unique code numbers assigned to the investigational product(s) and trial
subjects. Investigators should maintain records that document adequately that the
subjects were provided the doses specified by the protocol and reconcile all
investigational product(s) received from the sponsor.
Who should explain the correct use of the investigational product to each subject? -
ANSWER: The investigator, or a person designated by the investigator/institution,
should explain the correct use of the investigational product(s) to each subject and
should check, at intervals appropriate for the trial, that each subject is following the
instructions properly.
Can the ICF include language that causes the subject to waive any legal rights? -
ANSWER: None of the oral and written information concerning the trial, including
the written informed consent form, should contain any language that causes the
subject or the subject's legally acceptable representative to waive or to appear to
waive any legal rights, or that releases or appears to release the investigator, the
institution, the sponsor, or their agents from liability for negligence.
What twenty items need to be included in the ICF and its discussion? - ANSWER: (a)
That the trial involves research.
(b) The purpose of the trial.
(c) The trial treatment(s) and the probability for random assignment to each
treatment.
(d) The trial procedures to be followed, including all invasive procedures.
3|Page
