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ACRP-PM (ACRP PROJECT MANAGER SUBSPECIALTY) CERTIFICATION
EXAM QUESTIONS WITH DETAILED- VERIFIED ANSWERS- ALREADY
GRADED A+ || NEWEST EXAM
Project Management / Clinical Research
This ACRP-PM practice exam covers the essential domains of the Project
Manager Subspecialty certification: Ethical and Participant Safety
Considerations, Regulatory Affairs, Clinical Trial Operations, Study
Management, Scientific Concepts and Research Design, and Business
Management, Leadership, and Professionalism.
SECTION 1: ETHICAL AND PARTICIPANT SAFETY CONSIDERATIONS
QUESTION 1
A Clinical Research Project Manager is reviewing the informed consent
form (ICF) for a new multi-center trial. The principal investigator at one
site suggests adding a statement that the study drug is "completely safe"
to improve recruitment. What is the Project Manager's most appropriate
response?
A. Approve the addition since it will enhance recruitment
B. Request that the principal investigator consult with the sponsor's legal
team
C. Reject the addition as it violates the principle of informed consent
by making a guarantee of safety
D. Add the statement but include a footnote about potential risks
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Correct Answer: C. Reject the addition as it violates the principle of
informed consent by making a guarantee of safety
Rationale: Informed consent requires that participants are provided with
accurate and balanced information about potential risks and benefits.
Stating that a study drug is "completely safe" is misleading and violates
ethical principles outlined in the Declaration of Helsinki and ICH GCP
guidelines. The Project Manager must ensure that the ICF does not
contain coercive or misleading language and that it accurately reflects
the known risks.
QUESTION 2
During a routine monitoring visit, the Clinical Research Associate (CRA)
discovers that a subject's informed consent form is missing from the
site's regulatory binder. The site coordinator states that the subject
consented verbally but the signed form was misplaced. What is the
Project Manager's most appropriate course of action?
A. Instruct the site to have the subject sign a new consent form
retrospectively
B. Document the issue and report it as a protocol deviation
C. Instruct the site to recreate the consent form based on the verbal
consent
D. Ignore the issue since the subject received the intervention
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Correct Answer: B. Document the issue and report it as a protocol
deviation
Rationale: Informed consent must be documented in writing per ICH
GCP guidelines. A missing signed ICF is a serious violation of participant
protection requirements. The Project Manager must ensure the issue is
documented, reported as a deviation, and that corrective actions are
implemented to prevent recurrence. Retrospective consent is not
acceptable as it does not address the original lack of documentation.
QUESTION 3
A Project Manager is overseeing a trial that enrolls participants from a
vulnerable population (developmentally disabled adults). Which of the
following additional safeguards must be implemented?
A. No additional safeguards are needed if the protocol is IRB-approved
B. Assent from the participant and permission from a legally
authorized representative
C. Only permission from a legally authorized representative
D. Only assent from the participant
Correct Answer: B. Assent from the participant and permission from a
legally authorized representative
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Rationale: For vulnerable populations, including those with diminished
decision-making capacity, both assent from the participant (when
possible) and permission from a legally authorized representative are
required. This dual consent process ensures that the participant's
wishes are respected while protecting their rights and welfare. The
Project Manager must ensure that site staff are trained on these
requirements.
QUESTION 4
A Project Manager is reviewing the protocol for a new drug trial. The
investigator's brochure (IB) contains information about a serious adverse
event (SAE) that occurred in a previous animal study. How should this
information be handled in the informed consent process?
A. It does not need to be disclosed since it occurred in animals, not
humans
B. It must be disclosed if it is relevant to the participant's decision to
participate
C. It should be disclosed only if the participant asks about animal
studies
D. It should be disclosed only to participants who are animal lovers
Correct Answer: B. It must be disclosed if it is relevant to the
participant's decision to participate
ACRP-PM (ACRP PROJECT MANAGER SUBSPECIALTY) CERTIFICATION
EXAM QUESTIONS WITH DETAILED- VERIFIED ANSWERS- ALREADY
GRADED A+ || NEWEST EXAM
Project Management / Clinical Research
This ACRP-PM practice exam covers the essential domains of the Project
Manager Subspecialty certification: Ethical and Participant Safety
Considerations, Regulatory Affairs, Clinical Trial Operations, Study
Management, Scientific Concepts and Research Design, and Business
Management, Leadership, and Professionalism.
SECTION 1: ETHICAL AND PARTICIPANT SAFETY CONSIDERATIONS
QUESTION 1
A Clinical Research Project Manager is reviewing the informed consent
form (ICF) for a new multi-center trial. The principal investigator at one
site suggests adding a statement that the study drug is "completely safe"
to improve recruitment. What is the Project Manager's most appropriate
response?
A. Approve the addition since it will enhance recruitment
B. Request that the principal investigator consult with the sponsor's legal
team
C. Reject the addition as it violates the principle of informed consent
by making a guarantee of safety
D. Add the statement but include a footnote about potential risks
, Page 2 of 119
Correct Answer: C. Reject the addition as it violates the principle of
informed consent by making a guarantee of safety
Rationale: Informed consent requires that participants are provided with
accurate and balanced information about potential risks and benefits.
Stating that a study drug is "completely safe" is misleading and violates
ethical principles outlined in the Declaration of Helsinki and ICH GCP
guidelines. The Project Manager must ensure that the ICF does not
contain coercive or misleading language and that it accurately reflects
the known risks.
QUESTION 2
During a routine monitoring visit, the Clinical Research Associate (CRA)
discovers that a subject's informed consent form is missing from the
site's regulatory binder. The site coordinator states that the subject
consented verbally but the signed form was misplaced. What is the
Project Manager's most appropriate course of action?
A. Instruct the site to have the subject sign a new consent form
retrospectively
B. Document the issue and report it as a protocol deviation
C. Instruct the site to recreate the consent form based on the verbal
consent
D. Ignore the issue since the subject received the intervention
, Page 3 of 119
Correct Answer: B. Document the issue and report it as a protocol
deviation
Rationale: Informed consent must be documented in writing per ICH
GCP guidelines. A missing signed ICF is a serious violation of participant
protection requirements. The Project Manager must ensure the issue is
documented, reported as a deviation, and that corrective actions are
implemented to prevent recurrence. Retrospective consent is not
acceptable as it does not address the original lack of documentation.
QUESTION 3
A Project Manager is overseeing a trial that enrolls participants from a
vulnerable population (developmentally disabled adults). Which of the
following additional safeguards must be implemented?
A. No additional safeguards are needed if the protocol is IRB-approved
B. Assent from the participant and permission from a legally
authorized representative
C. Only permission from a legally authorized representative
D. Only assent from the participant
Correct Answer: B. Assent from the participant and permission from a
legally authorized representative
, Page 4 of 119
Rationale: For vulnerable populations, including those with diminished
decision-making capacity, both assent from the participant (when
possible) and permission from a legally authorized representative are
required. This dual consent process ensures that the participant's
wishes are respected while protecting their rights and welfare. The
Project Manager must ensure that site staff are trained on these
requirements.
QUESTION 4
A Project Manager is reviewing the protocol for a new drug trial. The
investigator's brochure (IB) contains information about a serious adverse
event (SAE) that occurred in a previous animal study. How should this
information be handled in the informed consent process?
A. It does not need to be disclosed since it occurred in animals, not
humans
B. It must be disclosed if it is relevant to the participant's decision to
participate
C. It should be disclosed only if the participant asks about animal
studies
D. It should be disclosed only to participants who are animal lovers
Correct Answer: B. It must be disclosed if it is relevant to the
participant's decision to participate
