ACRP-CP EXAM DETAILED QUESTIONS AND
CORRECT ANSWERS
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)
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.
CORRECT ANSWERS
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)
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.
