ACRP CP Exam Review 2023 – 2024
(Complete Solution)
Adverse Drug Reaction (ADR) - All noxious and unintended responses to a medicinal
product related to any dose (causal relationship is at least a reasonable possibility).
Regarding marketed medicinal products: a response to a drug which is noxious and
unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or
therapy of diseases or for modification of physiological function
Adverse Event (AE) - 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. (ICH GCP E6 1.2)
Audit - A systematic and independent examination of trial related activities and documents
to determine whether the evaluated trial related activities were conducted, and the data
were recorded, analyzed and accurately reported according to the protocol, sponsor's
standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable
regulatory requirement(s).
Audit Trail - Documentation that allows reconstruction of the course of events.
Blinding/Masking - A procedure in which one or more parties to the trial are kept unaware
of the treatment assignment. Single-blinding usually refers to the subject(s) being unaware,
and double- blinding usually refers to the subject(s), investigator(s), monitor, and, in some
cases, data analyst(s) being unaware of the treatment assignment(s). (ICH GCP E6 1.10)
Case Report Form (CRF) - A printed, optical, or electronic document designed to record all
of the protocol required information to be reported to the sponsor on each trial subject.
Clinical Trial/Study - Any investigation in human subjects intended to discover or verify
the clinical, pharmacological and/or other pharmacodynamic effects of an investigational
product(s), and/or to identify any adverse reactions to an investigational product(s),
and/or to study absorption, distribution, metabolism, and excretion of an investigational
product(s) with the object of ascertaining its safety and/or efficacy.
Clinical Trial/Study Report - A written description of a trial/study of any therapeutic,
prophylactic or diagnostic agent conducted in human subjects, in which the clinical and
statistical description, presentations, and analysis are fully integrated into a single report.
(ICH GCP E6 1.13)
Comparator (Product) - An investigational or marketed product (i.e., active control), or
placebo, used as a reference in a clinical trial.
, Compliance (in relation to trials) - Adherence to all the trial-related requirements, Good
Clinical Practice (GCP) requirements, and the applicable regulatory requirements.
Direct Access - Permission to examine, analyze, verify, and reproduce any records and
reports that are important to evaluation of a clinical trial.
Documentation - All records, in any form (including, but not limited to, written, electronic,
magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or
record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the
actions taken.
Essential Documents - Documents which individually and collectively permit evaluation of
the conduct of a study and the quality of the data produced.
Good Clinical Practice (GCP) - 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.
Impartial Witness - A person, who is independent of the trial, who cannot be unfairly
influenced by people involved with the trial, who attends the informed consent process if
the subject or the subject's legally acceptable representative cannot read, and who reads
the informed consent form and any other written information supplied to the subject.
Informed Consent - A process by which a subject voluntarily confirms his or her willingness
to participate in a particular trial, after having been informed of all aspects of the trial that
are relevant to the subject's decision to participate. Informed consent is documented by
means of a written, signed and dated informed consent form.
Inspection - The act by a regulatory authority(ies) of conducting an official review of
documents, facilities, records, and any other resources that are deemed by the
authority(ies) to be related to the clinical trial and that may be located at the site of the
trial, at the sponsor's and/or contract research organization's (CRO's) facilities, or at other
establishments deemed appropriate by the regulatory authority(ies).
Institutional Review Board (IRB) - An independent body constituted of medical, scientific,
and non-scientific members, whose responsibility is to ensure the protection of the rights,
safety and well-being of human subjects involved in a trial by, among other things,
reviewing, approving, and providing continuing review of trial protocol and amendments
and of the methods and material to be used in obtaining and documenting informed
consent of the trial subjects.
Investigational Product - A pharmaceutical form of an active ingredient or placebo being
tested or used as a reference in a clinical trial, including a product with a marketing
authorization when used or assembled (formulated or packaged) in a way different from
(Complete Solution)
Adverse Drug Reaction (ADR) - All noxious and unintended responses to a medicinal
product related to any dose (causal relationship is at least a reasonable possibility).
Regarding marketed medicinal products: a response to a drug which is noxious and
unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or
therapy of diseases or for modification of physiological function
Adverse Event (AE) - 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. (ICH GCP E6 1.2)
Audit - A systematic and independent examination of trial related activities and documents
to determine whether the evaluated trial related activities were conducted, and the data
were recorded, analyzed and accurately reported according to the protocol, sponsor's
standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable
regulatory requirement(s).
Audit Trail - Documentation that allows reconstruction of the course of events.
Blinding/Masking - A procedure in which one or more parties to the trial are kept unaware
of the treatment assignment. Single-blinding usually refers to the subject(s) being unaware,
and double- blinding usually refers to the subject(s), investigator(s), monitor, and, in some
cases, data analyst(s) being unaware of the treatment assignment(s). (ICH GCP E6 1.10)
Case Report Form (CRF) - A printed, optical, or electronic document designed to record all
of the protocol required information to be reported to the sponsor on each trial subject.
Clinical Trial/Study - Any investigation in human subjects intended to discover or verify
the clinical, pharmacological and/or other pharmacodynamic effects of an investigational
product(s), and/or to identify any adverse reactions to an investigational product(s),
and/or to study absorption, distribution, metabolism, and excretion of an investigational
product(s) with the object of ascertaining its safety and/or efficacy.
Clinical Trial/Study Report - A written description of a trial/study of any therapeutic,
prophylactic or diagnostic agent conducted in human subjects, in which the clinical and
statistical description, presentations, and analysis are fully integrated into a single report.
(ICH GCP E6 1.13)
Comparator (Product) - An investigational or marketed product (i.e., active control), or
placebo, used as a reference in a clinical trial.
, Compliance (in relation to trials) - Adherence to all the trial-related requirements, Good
Clinical Practice (GCP) requirements, and the applicable regulatory requirements.
Direct Access - Permission to examine, analyze, verify, and reproduce any records and
reports that are important to evaluation of a clinical trial.
Documentation - All records, in any form (including, but not limited to, written, electronic,
magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or
record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the
actions taken.
Essential Documents - Documents which individually and collectively permit evaluation of
the conduct of a study and the quality of the data produced.
Good Clinical Practice (GCP) - 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.
Impartial Witness - A person, who is independent of the trial, who cannot be unfairly
influenced by people involved with the trial, who attends the informed consent process if
the subject or the subject's legally acceptable representative cannot read, and who reads
the informed consent form and any other written information supplied to the subject.
Informed Consent - A process by which a subject voluntarily confirms his or her willingness
to participate in a particular trial, after having been informed of all aspects of the trial that
are relevant to the subject's decision to participate. Informed consent is documented by
means of a written, signed and dated informed consent form.
Inspection - The act by a regulatory authority(ies) of conducting an official review of
documents, facilities, records, and any other resources that are deemed by the
authority(ies) to be related to the clinical trial and that may be located at the site of the
trial, at the sponsor's and/or contract research organization's (CRO's) facilities, or at other
establishments deemed appropriate by the regulatory authority(ies).
Institutional Review Board (IRB) - An independent body constituted of medical, scientific,
and non-scientific members, whose responsibility is to ensure the protection of the rights,
safety and well-being of human subjects involved in a trial by, among other things,
reviewing, approving, and providing continuing review of trial protocol and amendments
and of the methods and material to be used in obtaining and documenting informed
consent of the trial subjects.
Investigational Product - A pharmaceutical form of an active ingredient or placebo being
tested or used as a reference in a clinical trial, including a product with a marketing
authorization when used or assembled (formulated or packaged) in a way different from
