ACRP CP CERTIFICATION FINAL TEST BANK (5 VERSIONS) EXAM
NEWEST 2026 (GRADED A+ 100% DETAILED VERIFIED ANSWERS)
What words are missing from the following in ICH GCP: The Sponsor should update the XXXX
as significant new information becomes available? - ANSWER✅ investigator's brochure
Who is responsible for implementing and maintaining quality assurance and quality control
systems with written SOPs: - ANSWER✅ sponsor
According to ICH GCP section 8, what is the purpose of IRB/IEC composition? - ANSWER✅
A. To document that the IRB/IEC is constituted in agreement with GCP
According to ICH GCP the IRB/IEC should promptly notify in writing: - ANSWER✅ A. Its
trial-related decisions/opinion
B. The reasons for its decisions/opinions
C. Procedures for appeal of its decisions/opinions
D. All of the above
According to section 5.17 the sponsor should expedite the reporting to all concerned
Investigator/Institution, XXXX of all ADRs that are both serious and unexpected. -
ANSWER✅ IRB/IEC and Regulatory Authority
Monitor should verify for the investigational product(s) that:
1) Investigational product(s) are supplied only to subjects who are eligible to receive it
,2) Subjects are provided with necessary instruction on properly using investigational
products
3) Receipt, use, and return of the investigational product(s) at the trial sites are controlled
and documented adequately
4) Storage times and conditions are acceptable - ANSWER✅ all of the above
According to ICH GCP which of the following is NOT listed under investigator responsibilities
for investigational product?
A. Maintain records of the investigational product delivery to the site
B. Explain the correct use of the investigational product(s) to each subject
C. Ensure that the investigational product(s) are used only in accordance with the approved
protocol
D. These are all included - ANSWER✅ D. These are all included
According to ICH GCP addendum the sponsor should develop a systematic, prioritized, XXXX
approach to monitoring clinical trials.
A. Approved
B. Inspected
C. Audited
,D. Risk-based - ANSWER✅ D. Risk-based
Which of the following are not part of the risk-based approach of quality management
system:
A. Critical Process and Data Identification
B. Risk review
C. Risk analysis
D. Risk reporting - ANSWER✅ C. Risk analysis
According to ICH GCP, all serious adverse events (SAEs) should be reported immediately to
the:
A. Sponsor
B. Sponsor and IRB/IEC
C. Sponsor, IRB/IEC and Institution
D. Applicable regulatory authority - ANSWER✅ A. Sponsor
According to ICH GCP, the investigator should submit written summaries of the trial status
to the IRB/IEC: - ANSWER✅ Annually, or more frequently, if requested by the IRB/IEC
Responsibility for investigational product(s) accountability at the trial site(s) rests with
XXXX - ANSWER✅ The investigator/institution
, According to Principles of ICH GCP, What should be obtained from every subject prior to
clinical trial participation? - ANSWER✅ Freely given informed consent
If the sponsor discontinues the clinical development of an investigational product, the
sponsor should notify all the: - ANSWER✅ Investigators and regulatory authorities
Before entering an agreement with an investigator/institution to conduct a trial, the
sponsor should provide the investigator(s)/institution(s) with the: - ANSWER✅ Protocol
and Investigator's Brochure
What does ICH GCP section 5.18.3 Extent and Nature of Monitoring, state about the method of
statistically controlled sampling? - ANSWER✅ may be an acceptable method for selecting
the data to be verified
Which of the following statement is true according to ICH GCP for the purposes of trial
monitoring:
A. The rights and well-being of human subjects are protected
B. The rights, safety and well-being of human subjects are protected - ANSWER✅ A
What word is missing from this ICH-GCP definition of the protocol : A XXXX document that
describes the objective(s), design, statistical considerations, and organization of a trial. -
ANSWER✅ written
NEWEST 2026 (GRADED A+ 100% DETAILED VERIFIED ANSWERS)
What words are missing from the following in ICH GCP: The Sponsor should update the XXXX
as significant new information becomes available? - ANSWER✅ investigator's brochure
Who is responsible for implementing and maintaining quality assurance and quality control
systems with written SOPs: - ANSWER✅ sponsor
According to ICH GCP section 8, what is the purpose of IRB/IEC composition? - ANSWER✅
A. To document that the IRB/IEC is constituted in agreement with GCP
According to ICH GCP the IRB/IEC should promptly notify in writing: - ANSWER✅ A. Its
trial-related decisions/opinion
B. The reasons for its decisions/opinions
C. Procedures for appeal of its decisions/opinions
D. All of the above
According to section 5.17 the sponsor should expedite the reporting to all concerned
Investigator/Institution, XXXX of all ADRs that are both serious and unexpected. -
ANSWER✅ IRB/IEC and Regulatory Authority
Monitor should verify for the investigational product(s) that:
1) Investigational product(s) are supplied only to subjects who are eligible to receive it
,2) Subjects are provided with necessary instruction on properly using investigational
products
3) Receipt, use, and return of the investigational product(s) at the trial sites are controlled
and documented adequately
4) Storage times and conditions are acceptable - ANSWER✅ all of the above
According to ICH GCP which of the following is NOT listed under investigator responsibilities
for investigational product?
A. Maintain records of the investigational product delivery to the site
B. Explain the correct use of the investigational product(s) to each subject
C. Ensure that the investigational product(s) are used only in accordance with the approved
protocol
D. These are all included - ANSWER✅ D. These are all included
According to ICH GCP addendum the sponsor should develop a systematic, prioritized, XXXX
approach to monitoring clinical trials.
A. Approved
B. Inspected
C. Audited
,D. Risk-based - ANSWER✅ D. Risk-based
Which of the following are not part of the risk-based approach of quality management
system:
A. Critical Process and Data Identification
B. Risk review
C. Risk analysis
D. Risk reporting - ANSWER✅ C. Risk analysis
According to ICH GCP, all serious adverse events (SAEs) should be reported immediately to
the:
A. Sponsor
B. Sponsor and IRB/IEC
C. Sponsor, IRB/IEC and Institution
D. Applicable regulatory authority - ANSWER✅ A. Sponsor
According to ICH GCP, the investigator should submit written summaries of the trial status
to the IRB/IEC: - ANSWER✅ Annually, or more frequently, if requested by the IRB/IEC
Responsibility for investigational product(s) accountability at the trial site(s) rests with
XXXX - ANSWER✅ The investigator/institution
, According to Principles of ICH GCP, What should be obtained from every subject prior to
clinical trial participation? - ANSWER✅ Freely given informed consent
If the sponsor discontinues the clinical development of an investigational product, the
sponsor should notify all the: - ANSWER✅ Investigators and regulatory authorities
Before entering an agreement with an investigator/institution to conduct a trial, the
sponsor should provide the investigator(s)/institution(s) with the: - ANSWER✅ Protocol
and Investigator's Brochure
What does ICH GCP section 5.18.3 Extent and Nature of Monitoring, state about the method of
statistically controlled sampling? - ANSWER✅ may be an acceptable method for selecting
the data to be verified
Which of the following statement is true according to ICH GCP for the purposes of trial
monitoring:
A. The rights and well-being of human subjects are protected
B. The rights, safety and well-being of human subjects are protected - ANSWER✅ A
What word is missing from this ICH-GCP definition of the protocol : A XXXX document that
describes the objective(s), design, statistical considerations, and organization of a trial. -
ANSWER✅ written
