ACRP-CP Exam Review(Based on
Declaration of Helsinki and ICH E2A,
E6_R2, E8, E9, E11)Rated 100%
Correct!!
Adverse Drug Reaction (ADR) - Answer 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) - 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. (ICH GCP E6 1.2)
Audit - Answer 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 - Answer Documentation that allows reconstruction of the course of
events.
Blinding/Masking - Answer 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) - Answer 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 - Answer 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 - Answer 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)
, ACRP-CP Exam Review(Based on
Declaration of Helsinki and ICH E2A,
E6_R2, E8, E9, E11)Rated 100%
Correct!!
Comparator (Product) - Answer An investigational or marketed product (i.e., active
control), or placebo, used as a reference in a clinical trial.
Compliance (in relation to trials) - Answer Adherence to all the trial-related
requirements, Good Clinical Practice (GCP) requirements, and the applicable
regulatory requirements.
Direct Access - Answer Permission to examine, analyze, verify, and reproduce any
records and reports that are important to evaluation of a clinical trial.
Documentation - Answer 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 - Answer Documents which individually and collectively permit
evaluation of the conduct of a study and the quality of the data produced.
Good Clinical Practice (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.
Impartial Witness - Answer 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 - Answer 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 - Answer 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).
Declaration of Helsinki and ICH E2A,
E6_R2, E8, E9, E11)Rated 100%
Correct!!
Adverse Drug Reaction (ADR) - Answer 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) - 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. (ICH GCP E6 1.2)
Audit - Answer 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 - Answer Documentation that allows reconstruction of the course of
events.
Blinding/Masking - Answer 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) - Answer 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 - Answer 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 - Answer 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)
, ACRP-CP Exam Review(Based on
Declaration of Helsinki and ICH E2A,
E6_R2, E8, E9, E11)Rated 100%
Correct!!
Comparator (Product) - Answer An investigational or marketed product (i.e., active
control), or placebo, used as a reference in a clinical trial.
Compliance (in relation to trials) - Answer Adherence to all the trial-related
requirements, Good Clinical Practice (GCP) requirements, and the applicable
regulatory requirements.
Direct Access - Answer Permission to examine, analyze, verify, and reproduce any
records and reports that are important to evaluation of a clinical trial.
Documentation - Answer 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 - Answer Documents which individually and collectively permit
evaluation of the conduct of a study and the quality of the data produced.
Good Clinical Practice (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.
Impartial Witness - Answer 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 - Answer 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 - Answer 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).
