ACRP-CP Exam Review 2024
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 the approved form, or
when used for an unapproved indication, or when used to gain further information about an
approved use.
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 the approved form, or
when used for an unapproved indication, or when used to gain further information about an
approved use.
