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ACRP CP FINAL EXAM LATEST 2024
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ACRP CP FINAL EXAM LATEST 2024
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ACRP CP FINAL EXAM LATEST 2024/2025 REALEXAM
Beneficence - ANSWER The moral obligation to act in a way that benefits others,
promoting their well-being and legitimate interests.
Pharmacokinetics - ANSWER Characterization of a drug's absorption, distribution,
metabolism, and excretion.
Pharmacodynamics - ANSWER Study of the biochemical and physiologic effects of
drugs.
Belmont Report - ANSWER Three principles - Respect for persons, beneficence,
and justice.
National Research Act (1974) - ANSWER Established the National Commission for
the Protection of Human Subjects of Biomedical and Behavioral Research, which
was tasked with developing ethical principles and guidelines for research involving
human participants.
National Commission (1975-1978) - ANSWER Was charged with identifying the
basic ethical principles that should underlie the conduct of biomedical and behavioral
research involving human subjects and developing guidelines to assure that such
research is conducted in accordance with those principles. (Wrote Belmont Report
after 4 years of discussions).
Declaration of Helsinki (1964) - ANSWER A statement of ethical principles for
medical research involving humans, emphasizing respect for individuals, informed
decisions, and vulnerable groups. Developed by the World Medical Association.
Declaration of Geneva - ANSWER The health of my patient will be my first
consideration.
International code of Medical Ethics - ANSWER A physician shall act in the
patient's best interest when providing medical care
Adverse Event - ANSWER Any untoward medical occurrence in a patient, or clinical
investigation subject, administered a pharmaceutical product and which does NOT
necessarily have a causal relationship with this treatment.
Adverse Drug Reaction (pre-approval) - ANSWER All noxious and unintended
responses to a medicinal product to any dose (Causal relationship is at least a
reasonable possibility.)
Serious Adverse Event - ANSWER Any untoward medical occurrence that at any
dose results in death or is life-threatening (the patient was at risk of death at the time
, of the event). Requires inpatient hospitalization, results in persistent or significant
disability/incapacity, or is a congenital anomaly/birth defect.
Expected vs Unexpected ADR - ANSWER Dependent on previously observed. Not
on the basis of what might be anticipated from the pharmacological properties of a
medicinal product.
Adverse Drug Reaction (marketed) - ANSWER Any noxious and unintended
response to a drug occurring at doses normally used in man for prophylaxis,
diagnosis, or therapy.
Unexpected ADR - ANSWER An adverse reaction, the nature or severity of which
is not consistent with the applicable product information.
Expedited Reporting - ANSWER Immediate reporting of serious and unexpected
adverse drug reactions to regulatory agencies within specified timeframes.
ICH E2A - ANSWER Clinical Safety Data Management
ICH E6 (R2) - ANSWER GCP
ICH E8 - ANSWER General Considerations - Guidance on designing quality into
clinical studies
ICH E9 - ANSWER Statistical Principles of Clinical Trials
ICH E11 (R1) - ANSWER Pediatric Populations
GCP - ANSWER A standard for the design, conduct, performance, monitoring,
auditing, recording, analyses, and reporting of clinical trials that provides assurance
that the data and reported results are credible and accurate, and that the rights,
integrity, and confidentiality of trial subjects are protected.
Documentation - ANSWER All records, in any form (including, but not limited to,
written electronic, magnetic, and optical records, and scans, x-rays, and ECGs) that
describe or record the methods, conduct, and/or results of a trial, the factors
affecting a trial, and the actions taken.
Essential Documents - ANSWER Documents which individually and collectively
permit evaluation of the conduct of a study and the quality of the data produced.
ICF - ANSWER Process in which a health care provider educates a patient about
the risks, benefits, and alternatives of a given procedure or intervention. The patient
must be competent to make a voluntary decision about whether to undergo the
procedure or intervention.
Audit - ANSWER A systematic and independent examination of trial related
activities and documents to determine whether the evaluated trial related activities
were conducted, and data were recorded, analyzed and accurately reported
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