ACRP-CP EXAM NEWEST 2026 ACTUAL EXAM TEST
BANK| 2 VERSIONS (VERSION A & B) WITH 650 REAL
EXAM QUESTIONS AND CORRECT DETAILED ANSWERS
(VERIFIED ANSWERS) GRADED A+| ACRP-CP
CERTIFICATION EXAM PREP 2026 (BRAND NEW!!)
Question 1
According to ICH GCP E6(R2), the responsibility for obtaining
informed consent from a trial subject lies with:
A) The sponsor
B) The investigator or a person designated by the investigator
C) The IRB chairperson
D) The subject's primary care physician
Answer: B) The investigator or a person designated by the
investigator
Rationale: ICH GCP 4.8.1 requires the investigator (or qualified
1
,designee) to obtain informed consent. The sponsor cannot obtain
consent; IRB approves the consent form but does not obtain it.
Question 2
A subject is unable to read due to a visual impairment. How
should informed consent be obtained?
A) The subject cannot enroll
B) An impartial witness must be present during the entire consent
discussion, and the subject makes a thumbprint or mark
C) The subject's family member signs for them
D) The investigator waives consent
Answer: B) An impartial witness must be present during the
entire consent discussion, and the subject makes a thumbprint or
mark
Rationale: ICH GCP 4.8.9 requires an impartial witness for
subjects unable to read. The consent form is read to the subject,
the witness attests that consent was given voluntarily.
2
,Question 3
What is the primary purpose of an Independent Ethics Committee
(IEC) or Institutional Review Board (IRB)?
A) To approve study drug shipments
B) To protect the rights, safety, and well-being of human subjects
C) To analyze study data
D) To recruit subjects
Answer: B) To protect the rights, safety, and well-being of
human subjects
Rationale: ICH GCP 3.1.1: The IEC/IRB safeguards subjects by
reviewing protocols, ICFs, investigator qualifications, and ongoing
safety data.
Question 4
Which of the following documents must be submitted to the IRB
for initial approval?
A) Protocol, informed consent form (ICF), investigator's brochure
3
, (IB), and subject recruitment materials
B) Only the protocol
C) Only the ICF
D) The final clinical study report
Answer: A) Protocol, informed consent form (ICF), investigator's
brochure (IB), and subject recruitment materials
Rationale: IRB requires all relevant documents for full board
review: protocol, ICF, IB, advertisements, questionnaires, and any
other subject-facing materials.
Question 5
A serious adverse event (SAE) that is unexpected and suspected
to be related to the investigational product is called a:
A) Adverse event (AE)
B) Serious adverse event (SAE)
C) Suspected Unexpected Serious Adverse Reaction (SUSAR)
D) Protocol deviation
4
BANK| 2 VERSIONS (VERSION A & B) WITH 650 REAL
EXAM QUESTIONS AND CORRECT DETAILED ANSWERS
(VERIFIED ANSWERS) GRADED A+| ACRP-CP
CERTIFICATION EXAM PREP 2026 (BRAND NEW!!)
Question 1
According to ICH GCP E6(R2), the responsibility for obtaining
informed consent from a trial subject lies with:
A) The sponsor
B) The investigator or a person designated by the investigator
C) The IRB chairperson
D) The subject's primary care physician
Answer: B) The investigator or a person designated by the
investigator
Rationale: ICH GCP 4.8.1 requires the investigator (or qualified
1
,designee) to obtain informed consent. The sponsor cannot obtain
consent; IRB approves the consent form but does not obtain it.
Question 2
A subject is unable to read due to a visual impairment. How
should informed consent be obtained?
A) The subject cannot enroll
B) An impartial witness must be present during the entire consent
discussion, and the subject makes a thumbprint or mark
C) The subject's family member signs for them
D) The investigator waives consent
Answer: B) An impartial witness must be present during the
entire consent discussion, and the subject makes a thumbprint or
mark
Rationale: ICH GCP 4.8.9 requires an impartial witness for
subjects unable to read. The consent form is read to the subject,
the witness attests that consent was given voluntarily.
2
,Question 3
What is the primary purpose of an Independent Ethics Committee
(IEC) or Institutional Review Board (IRB)?
A) To approve study drug shipments
B) To protect the rights, safety, and well-being of human subjects
C) To analyze study data
D) To recruit subjects
Answer: B) To protect the rights, safety, and well-being of
human subjects
Rationale: ICH GCP 3.1.1: The IEC/IRB safeguards subjects by
reviewing protocols, ICFs, investigator qualifications, and ongoing
safety data.
Question 4
Which of the following documents must be submitted to the IRB
for initial approval?
A) Protocol, informed consent form (ICF), investigator's brochure
3
, (IB), and subject recruitment materials
B) Only the protocol
C) Only the ICF
D) The final clinical study report
Answer: A) Protocol, informed consent form (ICF), investigator's
brochure (IB), and subject recruitment materials
Rationale: IRB requires all relevant documents for full board
review: protocol, ICF, IB, advertisements, questionnaires, and any
other subject-facing materials.
Question 5
A serious adverse event (SAE) that is unexpected and suspected
to be related to the investigational product is called a:
A) Adverse event (AE)
B) Serious adverse event (SAE)
C) Suspected Unexpected Serious Adverse Reaction (SUSAR)
D) Protocol deviation
4
