ACRP-CP Final Competency Certification Study Guide Exam Questions with Certified for Accuracy Answers 2024/2025
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ACRP-CP
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ACRP-CP
ACRP-CP Final Competency Certification Study Guide Exam Questions with Certified for Accuracy Answers 2024/2025
Declaration of Helsinki (1964) - correct answer Recommendations guiding medical doctors in biomedical research involving human subjects
WHO Guidelines (1996) Standards and Operati...
ACRP-CP Final Competency Certification
Study Guide Exam Questions with Certified
for Accuracy Answers 2024/2025
Declaration of Helsinki (1964) - correct answer
Recommendations guiding medical doctors in biomedical
research involving human subjects
WHO Guidelines (1996) Standards and Operational Guidance for
Ethics Review of Health-related Research with Human
Participants" - correct answer Documents designed to serve as
international guidelines for the review and conduct of research
involving human subjects
ICH E6 - correct answer Guideline for Good Clinical Practice
The use of prisoners in research is a concern under the Belmont
principle for Justice because: - correct answer Prisoners may
not be used to conduct research that only benefits the larger
society
What was the result of the Beecher article? - correct answer
Realization that ethical abuses are not limited to the Nazi regime
Issued in 1974, 45 CFR 46 raised to regulatory status: - correct
answer US Public Health Service Policy
What is included in the Nuremberg Code? - correct answer
Informed consent
,Informed consent is considered an application of which Belmont
principle? - correct answer Respect for persons
IRB (Institutional Review Board) - correct answer A review
committee established to help protect the rights and welfare of
human research subjects
Regulations require: - correct answer IRB review and approval
for research involving human subjects if it is conducted,
supported, or regulated by US federal departments and agencies
Federal regulations stipulate that an IRB can: - correct answer
Approve research, require modifications, disapprove research,
conduct continuing reviews, verify no material changes occurred
since previous review, observe, suspend/terminate approval
Conveyed committee review - correct answer Full committee
review. Standard type of review described in the federal
regulations. Must be used for the initial review of all studies that
are not eligible for expedited review or exemption
Expedited review - correct answer Can be used for established
categories and minor changes in previously approved research,
and for limited IRB review of select exemption categories
Categories for expedited review: - correct answer 1) The
research does not involve more than minimal risk
2) The entire research project must be consistent with one or
more of the federally defined categories (IND/IDE note required)
,Types of IRB submissions - correct answer 1) Application for
initial review
2) Application for continuing review: IRB must re-review greater
than minimal risk not less than once per year
3) Amendments or modifications
4) Reports of unanticipated problems
US Department of Health and Human Services - correct answer
Responsible for 45 CFR 46
National Institutes of Health (NIH) - correct answer Includes
funding agencies that provide federal funding for biomedical
research
U.S. Food and Drug Administration (FDA) - correct answer
Oversees the use of all drugs, devices, biologics, etc. including
their use in research with human subjects
International Council for Harmonisation (ICH) - correct answer
offers GP guidelines
A subject in a clinical research trial experiences a serious,
unanticipated adverse drug experience. How should the
investigator proceed, with respect to the IRB, after the discovery
of the adverse event occurrence? - correct answer Report the
adverse drug experience in a timely manner, in keeping with the
IRB's policies and procedures, using the forms or the mechanism
provided by the IRB
, How long is an investigator required to keep consent documents,
IRB correspondence, and research records? - correct answer A
minimum of three years after completion of the study
According to federal regulations, which of the following best
describes when expedited review of a new, proposed study may
be used by the IRB? - correct answer The study involves no
more than minimal risk and meets one of the allowable
categories of expedited review specified in federal regulations
Amendments involving changes to IRB approved protocols do
NOT need prior IRB approval if: - correct answer The changes
must be immediately implemented for the health and well-being
of the subjects
IRB continuing review of a greater than minimal risk approved
protocol that is currently enrolling subjects must: - correct
answer occur at least annually
Informed consent - correct answer The process that begins
with the recruitment and screening of a subject and the signing
of the consent document and continues throughout the subject's
involvement in the research and beyond study termination
Informed consent is mandated by the US Department of HHS at
45 CFR 46 and the US FDA at 21 CFR 50. These regulations
were developed to: - correct answer 1) protect human subjects
2) Ensure that potential study subjects clearly understand the
benefits and risks associated with their participation in a study 3)
Provide the potential study subjects with all information needed
to reach a decision on whether or not to participate in a research
study
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