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ACRP-CP FINAL EXAM WITH ACTUAL CORRECT QUESTIONS AND VERIFIED DETAILED ANSWERS |FREQUENTLY TESTED QUESTIONS AND SOLUTIONS |ALREADY GRADED A+|NEWEST|GUARANTEED PASS |LATEST UPDATE$20.49
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ACRP-CP FINAL EXAM WITH ACTUAL CORRECT QUESTIONS AND VERIFIED DETAILED ANSWERS |FREQUENTLY TESTED QUESTIONS AND SOLUTIONS |ALREADY GRADED A+|NEWEST|GUARANTEED PASS |LATEST UPDATE
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Course
ACRP-CP
Institution
ACRP-CP
ACRP-CP FINAL EXAM WITH
ACTUAL CORRECT QUESTIONS AND
VERIFIED DETAILED ANSWERS
|FREQUENTLY TESTED QUESTIONS AND
SOLUTIONS |ALREADY GRADED
A+|NEWEST|GUARANTEED PASS |LATEST
UPDATE
ACRP-CP FINAL EXAM 2024-2025 WITH
ACTUAL CORRECT QUESTIONS AND
VERIFIED DETAILED ANSWERS
|FREQUENTLY TESTED QUESTIONS AND
SOLUTIONS |ALREADY GRADED
A+|NEWEST|GUARANTEED PASS |LATEST
UPDATE
What is the IRB/IEC composition recommendation in ICH GCP?
(a) At least five members.
(b) At least one member whose primary area of interest is in a nonscientific area.
(c) At least one member who is independent of the institution/trial site.
According to ICH GCP The investigator should submit written summaries of the trial status to the
IRB/IEC:
Annually, or more frequently, if requested by the IRB/IEC
According to ICH GCP when should the sponsor update the Investigators Brochure?
As significant new information becomes available
According to ICH GCP an IRB/IEC should safeguard the:
Rights, safety and well-being of all trial subjects
In ICH GCP what is the difference in requirements between a non-therapeutic and a therapeutic clinical
trial?
Oral and proxy consent is not normally allowable for non-therapeutic trial
According to ICH GCP section 5.2 Contract Research Organization, Any trial-related duty and function
that is transferred to and assumed by a CRO should be specified in:
Writing
Documents which individually and collectively permit evaluation of the conduct of a study and the
quality of the data produced" is the definition of:
1|Page
,Essential documents
Which of the following documents should be obtained by IRB/IEC as per ICH GCP? A) subject
recruitment site B) subject recruitment procedures C) subject recruitment updates D) subject
recruitment strategy
B) subject recruitment procedure
Subinvestigator
Any individual member of the clinical trial team designated and supervised by the investigator at a trial
site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g.,
associates, residents, research fellows).
In ICH GCP what is the recommended timeline for the monitor to write the monitoring report?
There is no recommendation
According to ICH GCP the quality management system should use a ________________ approach.
Risk-based
What words are missing from the following in ICH GCP: The Sponsor should update the ___________ as
significant new information becomes available?
Investigators brochure
According to Principles of ICH GCP, a trial should be initiated and continued only if:
The anticipated benefits justify the risks
According to ICH GCP addendum the sponsor should develop a systematic, prioritized, ______________
approach to monitoring clinical trials.
Risk-based
According to the Principles of ICH GCP before a trial is initiated, foreseeable risks and inconveniences
should be weighed against the anticipated benefit for who?
individual trial subject and society
According to ICH GCP the IRB/IEC should conduct continuing review of each ongoing trial how
frequently?
at intervals appropriate to the degree of risk to human subjects, but at least once per year.
The IRB/IEC should establish, document in writing, and follow its procedures, which should include:
1. Determining its composition (names and qualifications of the members) and the authority under
which it is established. 2. Scheduling, notifying its members of, and conducting its meetings. 3.
Conducting initial and continuing review of trials. 4. Determining the frequency of continuing review, as
appropriate. 5. Providing, according to the applicable regulatory requirements, expedited review and
approval/favourable opinion of minor change(s) in ongoing trials that have the approval/favourable
2|Page
, opinion of the IRB/IEC. 6. Specifying that no subject should be admitted to a trial before the IRB/IEC
issues its written approval/ favourable opinion of the trial.
What is true for subjects in emergency situations when prior consent is not possible?
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?
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:
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
D
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
D
ICH GCP states the scientific integrity of the trial and the credibility of the data from the trial depend
substantially on the ___________
trial design
According to ICH GCP where advertisement for subject recruitment should be filed?
the investigator file only
According to ICH GCP how much source data verification (SDV) should be done?
There is no specification
3|Page
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