1|Page
ACRP CP FINAL EXAM NEWEST ACTUAL EXAM COMPLETE 150
QUESTIONS AND CORRECT DETAILED ANSWERS (VERIFIED
ANSWERS) |ALREADY GRADED A+
What is true for subjects in emergency situations when prior consent is not
possible? - ANSWER-They can be included if the measures described in the
protocol and/or elsewhere, with documented approval/ favourable opinion by
the IRB/IEC
Before the clinical phase of the trial commences where should master
randomization list be filed? - ANSWER-Both a sponsor and a third party
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 investigators brochure
Which of the following is NOT included in protocol section 6.5 selection and
withdrawal of subjects:
A) Subject inclusion criteria.
B) Subject exclusion criteria.
C) Subject withdrawal criteria
D) Subject retention criteria - ANSWER-D
,2|Page
According to ICH GCP Section 5.8 Compensation to Subjects and
Investigators which of the following is not true:
A) Sponsor should provide insurance
B) Sponsor should indemnify investigator against claims arising from
negligence
C) Sponsor should indemnify investigator against claims arising from
malpractice
D) both b and c - ANSWER-D
ICH GCP states the scientific integrity of the trial and the credibility of the
data from the trial depend substantially on the ___________ - ANSWER-trial
design
According to ICH GCP where advertisement for subject recruitment should
be filed? - ANSWER-the investigator file only
According to ICH GCP how much source data verification (SDV) should be
done? - ANSWER-There is no specification
The investigator(s) should be qualified by ______________ to assume
responsibility for the proper conduct of the trial. - ANSWER-Education,
training, and experience
,3|Page
Who is responsible for implementing and maintaining quality assurance and
quality control systems with written SOPs: - ANSWER-sponsor
Who should ensure that it is specified in the protocol or other written
agreement that the investigator(s)/institution(s) will permit trial-related
monitoring, audits, IRB/IEC review, and regulatory inspection(s), providing
direct access to source data/documents? - ANSWER-Sponsor
According to ICH GCP how soon should serious adverse events (SAEs) be
reported by the investigator? - ANSWER-immediately to the sponsor
According to ICH GCP, Documentation that allows reconstruction of the
course of events is: - ANSWER-Audit trail
According to ICH GCP contract is _____________, dated, and signed
agreement between two or more involved parties that sets out any
arrangements on delegation and distribution of tasks and obligations and, if
appropriate, on financial matters. - ANSWER-Written
Before the clinical phase of the trial commences where should the sample of
labels attached to investigational product(s) be filed? - ANSWER-The
sponsor file only
, 4|Page
According to ICH GCP the IRB/IEC should promptly notify in writing:
A) it's trial-related decisions / opinions
B) The reasons for its decisions / opinions
C) Procedures for appeal of its decisions / opinions
D) all of the above - ANSWER-D
According to ICH GCP Adverse events and/or laboratory abnormalities
identified in the protocol as critical evaluations should be reported to the: -
ANSWER-sponsor
During the clinical conduct of the trial how completed CRFs be filed? -
ANSWER-Copy in investigator file and original in sponsor file
Where should trial initiation report be filed? - ANSWER-both the sponsor and
investigator files
According to ICH GCP what is the sponsor responsibility regarding supply of
Investigational Products? - ANSWER-To supply the IP to the investigator
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.
ACRP CP FINAL EXAM NEWEST ACTUAL EXAM COMPLETE 150
QUESTIONS AND CORRECT DETAILED ANSWERS (VERIFIED
ANSWERS) |ALREADY GRADED A+
What is true for subjects in emergency situations when prior consent is not
possible? - ANSWER-They can be included if the measures described in the
protocol and/or elsewhere, with documented approval/ favourable opinion by
the IRB/IEC
Before the clinical phase of the trial commences where should master
randomization list be filed? - ANSWER-Both a sponsor and a third party
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 investigators brochure
Which of the following is NOT included in protocol section 6.5 selection and
withdrawal of subjects:
A) Subject inclusion criteria.
B) Subject exclusion criteria.
C) Subject withdrawal criteria
D) Subject retention criteria - ANSWER-D
,2|Page
According to ICH GCP Section 5.8 Compensation to Subjects and
Investigators which of the following is not true:
A) Sponsor should provide insurance
B) Sponsor should indemnify investigator against claims arising from
negligence
C) Sponsor should indemnify investigator against claims arising from
malpractice
D) both b and c - ANSWER-D
ICH GCP states the scientific integrity of the trial and the credibility of the
data from the trial depend substantially on the ___________ - ANSWER-trial
design
According to ICH GCP where advertisement for subject recruitment should
be filed? - ANSWER-the investigator file only
According to ICH GCP how much source data verification (SDV) should be
done? - ANSWER-There is no specification
The investigator(s) should be qualified by ______________ to assume
responsibility for the proper conduct of the trial. - ANSWER-Education,
training, and experience
,3|Page
Who is responsible for implementing and maintaining quality assurance and
quality control systems with written SOPs: - ANSWER-sponsor
Who should ensure that it is specified in the protocol or other written
agreement that the investigator(s)/institution(s) will permit trial-related
monitoring, audits, IRB/IEC review, and regulatory inspection(s), providing
direct access to source data/documents? - ANSWER-Sponsor
According to ICH GCP how soon should serious adverse events (SAEs) be
reported by the investigator? - ANSWER-immediately to the sponsor
According to ICH GCP, Documentation that allows reconstruction of the
course of events is: - ANSWER-Audit trail
According to ICH GCP contract is _____________, dated, and signed
agreement between two or more involved parties that sets out any
arrangements on delegation and distribution of tasks and obligations and, if
appropriate, on financial matters. - ANSWER-Written
Before the clinical phase of the trial commences where should the sample of
labels attached to investigational product(s) be filed? - ANSWER-The
sponsor file only
, 4|Page
According to ICH GCP the IRB/IEC should promptly notify in writing:
A) it's trial-related decisions / opinions
B) The reasons for its decisions / opinions
C) Procedures for appeal of its decisions / opinions
D) all of the above - ANSWER-D
According to ICH GCP Adverse events and/or laboratory abnormalities
identified in the protocol as critical evaluations should be reported to the: -
ANSWER-sponsor
During the clinical conduct of the trial how completed CRFs be filed? -
ANSWER-Copy in investigator file and original in sponsor file
Where should trial initiation report be filed? - ANSWER-both the sponsor and
investigator files
According to ICH GCP what is the sponsor responsibility regarding supply of
Investigational Products? - ANSWER-To supply the IP to the investigator
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.
