ACRP CP FINAL EXAM LATEST 2025 REAL EXAM 150
QUESTIONS AND CORRECT ANSWERS | A+ GRADE ASSURED
Question 1
According to ICH GCP E6 (R2), which of the following is the primary
responsibility of the Investigator?
A) To develop the clinical trial protocol.
B) To obtain marketing authorization for the investigational product.
C) To protect the rights, safety, and well-being of trial subjects.
D) To monitor the clinical trial sites.
E) To manufacture the investigational product.
Correct Answer: C) To protect the rights, safety, and well-being of trial
subjects.
Rationale: ICH GCP E6 (R2) clearly states that the Investigator is
ultimately responsible for the conduct of the trial at the site and for
ensuring the rights, safety, and well-being of trial subjects are
protected (ICH GCP 4.1.1).
Question 2
What is the primary purpose of an Institutional Review Board (IRB) or
Independent Ethics Committee (IEC)?
A) To manage the budget for clinical trials.
B) To ensure the scientific validity of the research.
C) To protect the rights, safety, and well-being of human subjects.
D) To audit clinical trial data for accuracy.
E) To recruit participants for clinical trials.
Correct Answer: C) To protect the rights, safety, and well-being of
human subjects.
Rationale: The fundamental purpose of an IRB/IEC is to safeguard the
rights, safety, and well-being of human participants involved in
research. They review and approve research protocols, informed
consent documents, and amendments (ICH GCP 3.1.1).
Question 3
Before a subject can participate in a clinical trial, the Investigator must
obtain "informed consent." Which of the following elements is essential for
valid informed consent?
A) The subject must be paid a substantial amount for participation.
B) The consent process must be completed by a family member.
C) The subject must voluntarily agree to participate after being fully
informed.
D) The consent form must be signed by the Sponsor.
,E) The subject must understand all medical terminology in the consent form.
Correct Answer: C) The subject must voluntarily agree to participate
after being fully informed.
Rationale: Informed consent requires that the subject (or their legally
acceptable representative) voluntarily confirms their willingness to
participate in a particular trial, after having been informed of all
aspects of the trial that are relevant to the subject's decision to
participate (ICH GCP 1.28, 4.8.8).
Question 4
Which document provides a written description of a clinical trial's objectives,
design, methodology, statistical considerations, and organization?
A) Investigator's Brochure (IB)
B) Case Report Form (CRF)
C) Clinical Study Report (CSR)
D) Protocol
E) Informed Consent Form (ICF)
Correct Answer: D) Protocol
Rationale: The protocol is the foundational document that details all
aspects of a clinical trial, including its rationale, objectives, design,
methodology, statistical considerations, organization, and the
conditions under which it is to be performed (ICH GCP 1.44, 6.1).
Question 5
What does the acronym "SAE" stand for in clinical research?
A) Standard Adverse Event
B) Serious Adverse Event
C) Study Assessment Event
D) Subject Enrollment
E) System Audit Error
Correct Answer: B) Serious Adverse Event
Rationale: SAE stands for Serious Adverse Event. An SAE is any
untoward medical occurrence that at any dose results in death, is
life-threatening, requires inpatient hospitalization or prolongation
of existing hospitalization, results in persistent or significant
disability/incapacity, or is a congenital anomaly/birth defect (ICH
GCP 1.50).
Question 6
Who is ultimately responsible for medical care given to a trial subject, even if
it is not related to the investigational product?
,A) The Sponsor
B) The Institutional Review Board (IRB)
C) The Investigator (or sub-investigator if delegated)
D) The Clinical Research Coordinator (CRC)
E) The Monitor
Correct Answer: C) The Investigator (or sub-investigator if delegated)
Rationale: The Investigator is responsible for all medical decisions,
including unrelated medical care, given to a subject while they are
under the Investigator's care in the context of the clinical trial (ICH
GCP 4.3.1).
Question 7
The collection of essential documents for a clinical trial is referred to as the:
A) Subject Source Document
B) Case Report Form (CRF)
C) Trial Master File (TMF)
D) Investigator's Brochure (IB)
E) Study Budget
Correct Answer: C) Trial Master File (TMF)
Rationale: The TMF is the collection of essential documents that
individually and collectively permit evaluation of the conduct of a
clinical trial and the quality of the data produced. These documents
serve to show that the Investigator and Sponsor have complied with
the principles of GCP (ICH GCP 8).
Question 8
Which of the following describes "Source Documents"?
A) Electronic data capture systems only.
B) Original documents, data, and records (e.g., hospital records, clinic charts,
lab results) necessary for the reconstruction of the trial.
C) Copies of Case Report Forms (CRFs).
D) Only documents signed by the IRB.
E) Only the protocol and Investigator's Brochure.
Correct Answer: B) Original documents, data, and records (e.g.,
hospital records, clinic charts, lab results) necessary for the
reconstruction of the trial.
Rationale: Source documents are original documents, data, and
records (e.g., hospital records, clinic charts, laboratory notes,
memoranda, subjects' diaries or evaluation checklists, pharmacy
dispensing records, recorded data from automated instruments,
, copies or transcriptions certified as being exact copies) that are
necessary for the reconstruction of the trial (ICH GCP 1.52, 6.4.9).
Question 9
What is the primary role of a Clinical Research Monitor (CRA)?
A) To perform all clinical procedures on subjects.
B) To conduct statistical analysis of trial data.
C) To act as a liaison between the Sponsor and the Investigator, verifying
compliance with the protocol and regulatory requirements.
D) To enroll subjects into the clinical trial.
E) To write the Investigator's Brochure.
Correct Answer: C) To act as a liaison between the Sponsor and the
Investigator, verifying compliance with the protocol and regulatory
requirements.
Rationale: The CRA is the Sponsor's representative who oversees the
conduct of the study at the site, verifies that the rights and well-
being of human subjects are protected, that the reported trial data
are accurate, complete, and verifiable from source documents, and
that the conduct of the trial is in compliance with the currently
approved protocol/amendments, GCP, and applicable regulatory
requirements (ICH GCP 5.18.1).
Question 10
Which of the following statements about protocol amendments is true?
A) They can be implemented immediately by the Investigator without IRB/IEC
approval.
B) They must be approved by the IRB/IEC before implementation, except
when necessary to eliminate an immediate hazard to subjects.
C) They are only required for changes to the study budget.
D) They do not require a revision to the informed consent form.
E) They are written by the Monitor during site visits.
Correct Answer: B) They must be approved by the IRB/IEC before
implementation, except when necessary to eliminate an immediate
hazard to subjects.
Rationale: The Investigator should not implement any deviation from,
or changes to the protocol without agreement by the Sponsor and
prior review and documented approval from the IRB/IEC of an
amendment, except when necessary to eliminate an immediate
hazard to the subjects or when the change involves only logistical or
administrative aspects of the trial (ICH GCP 4.5.2).
QUESTIONS AND CORRECT ANSWERS | A+ GRADE ASSURED
Question 1
According to ICH GCP E6 (R2), which of the following is the primary
responsibility of the Investigator?
A) To develop the clinical trial protocol.
B) To obtain marketing authorization for the investigational product.
C) To protect the rights, safety, and well-being of trial subjects.
D) To monitor the clinical trial sites.
E) To manufacture the investigational product.
Correct Answer: C) To protect the rights, safety, and well-being of trial
subjects.
Rationale: ICH GCP E6 (R2) clearly states that the Investigator is
ultimately responsible for the conduct of the trial at the site and for
ensuring the rights, safety, and well-being of trial subjects are
protected (ICH GCP 4.1.1).
Question 2
What is the primary purpose of an Institutional Review Board (IRB) or
Independent Ethics Committee (IEC)?
A) To manage the budget for clinical trials.
B) To ensure the scientific validity of the research.
C) To protect the rights, safety, and well-being of human subjects.
D) To audit clinical trial data for accuracy.
E) To recruit participants for clinical trials.
Correct Answer: C) To protect the rights, safety, and well-being of
human subjects.
Rationale: The fundamental purpose of an IRB/IEC is to safeguard the
rights, safety, and well-being of human participants involved in
research. They review and approve research protocols, informed
consent documents, and amendments (ICH GCP 3.1.1).
Question 3
Before a subject can participate in a clinical trial, the Investigator must
obtain "informed consent." Which of the following elements is essential for
valid informed consent?
A) The subject must be paid a substantial amount for participation.
B) The consent process must be completed by a family member.
C) The subject must voluntarily agree to participate after being fully
informed.
D) The consent form must be signed by the Sponsor.
,E) The subject must understand all medical terminology in the consent form.
Correct Answer: C) The subject must voluntarily agree to participate
after being fully informed.
Rationale: Informed consent requires that the subject (or their legally
acceptable representative) voluntarily confirms their willingness to
participate in a particular trial, after having been informed of all
aspects of the trial that are relevant to the subject's decision to
participate (ICH GCP 1.28, 4.8.8).
Question 4
Which document provides a written description of a clinical trial's objectives,
design, methodology, statistical considerations, and organization?
A) Investigator's Brochure (IB)
B) Case Report Form (CRF)
C) Clinical Study Report (CSR)
D) Protocol
E) Informed Consent Form (ICF)
Correct Answer: D) Protocol
Rationale: The protocol is the foundational document that details all
aspects of a clinical trial, including its rationale, objectives, design,
methodology, statistical considerations, organization, and the
conditions under which it is to be performed (ICH GCP 1.44, 6.1).
Question 5
What does the acronym "SAE" stand for in clinical research?
A) Standard Adverse Event
B) Serious Adverse Event
C) Study Assessment Event
D) Subject Enrollment
E) System Audit Error
Correct Answer: B) Serious Adverse Event
Rationale: SAE stands for Serious Adverse Event. An SAE is any
untoward medical occurrence that at any dose results in death, is
life-threatening, requires inpatient hospitalization or prolongation
of existing hospitalization, results in persistent or significant
disability/incapacity, or is a congenital anomaly/birth defect (ICH
GCP 1.50).
Question 6
Who is ultimately responsible for medical care given to a trial subject, even if
it is not related to the investigational product?
,A) The Sponsor
B) The Institutional Review Board (IRB)
C) The Investigator (or sub-investigator if delegated)
D) The Clinical Research Coordinator (CRC)
E) The Monitor
Correct Answer: C) The Investigator (or sub-investigator if delegated)
Rationale: The Investigator is responsible for all medical decisions,
including unrelated medical care, given to a subject while they are
under the Investigator's care in the context of the clinical trial (ICH
GCP 4.3.1).
Question 7
The collection of essential documents for a clinical trial is referred to as the:
A) Subject Source Document
B) Case Report Form (CRF)
C) Trial Master File (TMF)
D) Investigator's Brochure (IB)
E) Study Budget
Correct Answer: C) Trial Master File (TMF)
Rationale: The TMF is the collection of essential documents that
individually and collectively permit evaluation of the conduct of a
clinical trial and the quality of the data produced. These documents
serve to show that the Investigator and Sponsor have complied with
the principles of GCP (ICH GCP 8).
Question 8
Which of the following describes "Source Documents"?
A) Electronic data capture systems only.
B) Original documents, data, and records (e.g., hospital records, clinic charts,
lab results) necessary for the reconstruction of the trial.
C) Copies of Case Report Forms (CRFs).
D) Only documents signed by the IRB.
E) Only the protocol and Investigator's Brochure.
Correct Answer: B) Original documents, data, and records (e.g.,
hospital records, clinic charts, lab results) necessary for the
reconstruction of the trial.
Rationale: Source documents are original documents, data, and
records (e.g., hospital records, clinic charts, laboratory notes,
memoranda, subjects' diaries or evaluation checklists, pharmacy
dispensing records, recorded data from automated instruments,
, copies or transcriptions certified as being exact copies) that are
necessary for the reconstruction of the trial (ICH GCP 1.52, 6.4.9).
Question 9
What is the primary role of a Clinical Research Monitor (CRA)?
A) To perform all clinical procedures on subjects.
B) To conduct statistical analysis of trial data.
C) To act as a liaison between the Sponsor and the Investigator, verifying
compliance with the protocol and regulatory requirements.
D) To enroll subjects into the clinical trial.
E) To write the Investigator's Brochure.
Correct Answer: C) To act as a liaison between the Sponsor and the
Investigator, verifying compliance with the protocol and regulatory
requirements.
Rationale: The CRA is the Sponsor's representative who oversees the
conduct of the study at the site, verifies that the rights and well-
being of human subjects are protected, that the reported trial data
are accurate, complete, and verifiable from source documents, and
that the conduct of the trial is in compliance with the currently
approved protocol/amendments, GCP, and applicable regulatory
requirements (ICH GCP 5.18.1).
Question 10
Which of the following statements about protocol amendments is true?
A) They can be implemented immediately by the Investigator without IRB/IEC
approval.
B) They must be approved by the IRB/IEC before implementation, except
when necessary to eliminate an immediate hazard to subjects.
C) They are only required for changes to the study budget.
D) They do not require a revision to the informed consent form.
E) They are written by the Monitor during site visits.
Correct Answer: B) They must be approved by the IRB/IEC before
implementation, except when necessary to eliminate an immediate
hazard to subjects.
Rationale: The Investigator should not implement any deviation from,
or changes to the protocol without agreement by the Sponsor and
prior review and documented approval from the IRB/IEC of an
amendment, except when necessary to eliminate an immediate
hazard to the subjects or when the change involves only logistical or
administrative aspects of the trial (ICH GCP 4.5.2).
