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CP ACRP EXAM| ACRP CP FINAL EXAM PRACTICE
QUESTIONS WITH CORRECT ANSWERS
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 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
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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.
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.
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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.
(e) The subject's responsibilities.
(f) Those aspects of the trial that are experimental.
(g) The reasonably foreseeable risks or inconveniences to the subject and, when
applicable, to an embryo, fetus, or nursing infant.
(h) The reasonably expected benefits. When there is no intended clinical benefit to the
subject, the subject should be made aware of this.
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(i) The alternative procedure(s) or course(s) of treatment that may be available to the
subject, and their important potential benefits and risks.
(j) The compensation and/or treatment available to the subject in the event of trial related
injury.
(k) The anticipated prorated payment, if any, to the subject for participating in the trial.
(l) The anticipated expenses, if any, to the subject for participating in the trial.
(m) That the subject's participation in the trial is voluntary and that the subject may refuse
to participate or withdraw from the trial, at any time, without penalty or loss of benefits to
which the subject is otherwise entitled.
(n) That the monitor(s), the auditor(s), the IRB/IEC, and the regulatory authority(ies) will
be granted direct access to the subject's original medical records for verification of clinical
trial procedures and/or data, without violating the confidentiality of the subject, to the extent
permitted by the applicable laws and regulations and that, by signing a written informed
consent form, the subject or the subject's legally acceptable representative is authorizing such
access.
(o) That records identifying the subject will be kept confidential and, to the extent permi
Should each patient receive a copy of the signed and dated written ICF? -- ANSWER--Prior
to participation in the trial, the subject or the subject's legally acceptable representative
should receive a copy of the signed and dated written informed consent form and any other
written information provided to the subjects. During a subject's participation in the trial, the
CP ACRP EXAM| ACRP CP FINAL EXAM PRACTICE
QUESTIONS WITH CORRECT ANSWERS
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 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
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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.
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.
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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.
(e) The subject's responsibilities.
(f) Those aspects of the trial that are experimental.
(g) The reasonably foreseeable risks or inconveniences to the subject and, when
applicable, to an embryo, fetus, or nursing infant.
(h) The reasonably expected benefits. When there is no intended clinical benefit to the
subject, the subject should be made aware of this.
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(i) The alternative procedure(s) or course(s) of treatment that may be available to the
subject, and their important potential benefits and risks.
(j) The compensation and/or treatment available to the subject in the event of trial related
injury.
(k) The anticipated prorated payment, if any, to the subject for participating in the trial.
(l) The anticipated expenses, if any, to the subject for participating in the trial.
(m) That the subject's participation in the trial is voluntary and that the subject may refuse
to participate or withdraw from the trial, at any time, without penalty or loss of benefits to
which the subject is otherwise entitled.
(n) That the monitor(s), the auditor(s), the IRB/IEC, and the regulatory authority(ies) will
be granted direct access to the subject's original medical records for verification of clinical
trial procedures and/or data, without violating the confidentiality of the subject, to the extent
permitted by the applicable laws and regulations and that, by signing a written informed
consent form, the subject or the subject's legally acceptable representative is authorizing such
access.
(o) That records identifying the subject will be kept confidential and, to the extent permi
Should each patient receive a copy of the signed and dated written ICF? -- ANSWER--Prior
to participation in the trial, the subject or the subject's legally acceptable representative
should receive a copy of the signed and dated written informed consent form and any other
written information provided to the subjects. During a subject's participation in the trial, the
