ACRP-CP EXAM (ELABORATIONS)
NEWEST ACTUAL EXAM WITH
COMPLETE QUESTIONS AND
DETAILED ANSWERS LATEST
UPDATE
Which agency provides federal funding for biomedical research?
National Institutes of Health (NIH)
Which organization oversees the use of drugs, devices, and
biologics in research with human subjects?
U.S. Food and Drug Administration (FDA)
Which council provides Good Clinical Practice (GCP)
guidelines?
International Council for Harmonisation (ICH)
,If a serious, unanticipated adverse drug experience occurs, what
should the investigator do?
Report the adverse drug experience in a timely manner
using the IRB's mechanism
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
When may an IRB use expedited review for a new, proposed
study?
The study involves no more than minimal risk and meets one
of the allowable categories of expedited review
Amendments to IRB-approved protocols do not need prior IRB
approval if:A) The changes are minor and cosmetic
The changes must be immediately implemented for the
health and well-being of the subjects
, For a protocol currently enrolling subjects, IRB continuing
review must occur:
At least annually
What should be communicated in informed consent about
disclosing clinically relevant research results?
A statement regarding whether clinically relevant research
results, including individual research results, will be
disclosed to subjects, and if so, under what conditions
What is the primary purpose of an Institutional Review Board
(IRB)?
Protect participants' welfare and rights
Regulations require IRB review and approval for research
involving human subjects if it is:
Conducted, supported, or regulated by US federal
departments and agencies
NEWEST ACTUAL EXAM WITH
COMPLETE QUESTIONS AND
DETAILED ANSWERS LATEST
UPDATE
Which agency provides federal funding for biomedical research?
National Institutes of Health (NIH)
Which organization oversees the use of drugs, devices, and
biologics in research with human subjects?
U.S. Food and Drug Administration (FDA)
Which council provides Good Clinical Practice (GCP)
guidelines?
International Council for Harmonisation (ICH)
,If a serious, unanticipated adverse drug experience occurs, what
should the investigator do?
Report the adverse drug experience in a timely manner
using the IRB's mechanism
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
When may an IRB use expedited review for a new, proposed
study?
The study involves no more than minimal risk and meets one
of the allowable categories of expedited review
Amendments to IRB-approved protocols do not need prior IRB
approval if:A) The changes are minor and cosmetic
The changes must be immediately implemented for the
health and well-being of the subjects
, For a protocol currently enrolling subjects, IRB continuing
review must occur:
At least annually
What should be communicated in informed consent about
disclosing clinically relevant research results?
A statement regarding whether clinically relevant research
results, including individual research results, will be
disclosed to subjects, and if so, under what conditions
What is the primary purpose of an Institutional Review Board
(IRB)?
Protect participants' welfare and rights
Regulations require IRB review and approval for research
involving human subjects if it is:
Conducted, supported, or regulated by US federal
departments and agencies
