ACRP CP EXAM NEWEST 2025/26 ACTUAL QUESTIONS AND
CORRECT VERIFIED DETAILED ANSWERS 100% ASSURED
SUCCESS GRADED A+
Regulations require:
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:
Approve research, require modifications, disapprove research,
conduct continuing reviews, verify no material changes occurred
since previous review, observe, suspend/terminate approval
Conveyed committee review
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
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:
,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
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
Responsible for 45 cfr 46
National institutes of health (nih)
Includes funding agencies that provide federal funding for
biomedical research
U.s. food and drug administration (fda)
Oversees the use of all drugs, devices, biologics, etc. Including
their use in research with human subjects
International council for harmonisation (ich)
,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?
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?
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?
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:
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:
Occur at least annually
Informed consent
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:
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
Broad consent
Prospective consent for unspecified future research
CORRECT VERIFIED DETAILED ANSWERS 100% ASSURED
SUCCESS GRADED A+
Regulations require:
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:
Approve research, require modifications, disapprove research,
conduct continuing reviews, verify no material changes occurred
since previous review, observe, suspend/terminate approval
Conveyed committee review
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
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:
,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
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
Responsible for 45 cfr 46
National institutes of health (nih)
Includes funding agencies that provide federal funding for
biomedical research
U.s. food and drug administration (fda)
Oversees the use of all drugs, devices, biologics, etc. Including
their use in research with human subjects
International council for harmonisation (ich)
,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?
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?
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?
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:
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:
Occur at least annually
Informed consent
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:
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
Broad consent
Prospective consent for unspecified future research
