ACRP-CP Exam Review UPDATED
ACTUAL Questions and CORRECT
Answers
Adverse Drug Reaction (ADR) - CORRECT ANSWERS 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) - CORRECT ANSWERS 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 - CORRECT ANSWERS 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 - CORRECT ANSWERS Documentation that allows reconstruction of the
course of events.
Blinding/Masking - CORRECT ANSWERS 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) - CORRECT ANSWERS 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 - CORRECT ANSWERS 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 - CORRECT ANSWERS 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) - CORRECT ANSWERS An investigational or marketed product
(i.e., active control), or placebo, used as a reference in a clinical trial.
Compliance (in relation to trials) - CORRECT ANSWERS Adherence to all the trial-
related requirements, Good Clinical Practice (GCP) requirements, and the applicable regulatory
requirements.
Direct Access - CORRECT ANSWERS Permission to examine, analyze, verify, and
reproduce any records and reports that are important to evaluation of a clinical trial.
Documentation - CORRECT ANSWERS 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 - CORRECT ANSWERS Documents which individually and
collectively permit evaluation of the conduct of a study and the quality of the data produced.
Good Clinical Practice (GCP) - CORRECT ANSWERS 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.
ACTUAL Questions and CORRECT
Answers
Adverse Drug Reaction (ADR) - CORRECT ANSWERS 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) - CORRECT ANSWERS 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 - CORRECT ANSWERS 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 - CORRECT ANSWERS Documentation that allows reconstruction of the
course of events.
Blinding/Masking - CORRECT ANSWERS 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) - CORRECT ANSWERS 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 - CORRECT ANSWERS 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 - CORRECT ANSWERS 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) - CORRECT ANSWERS An investigational or marketed product
(i.e., active control), or placebo, used as a reference in a clinical trial.
Compliance (in relation to trials) - CORRECT ANSWERS Adherence to all the trial-
related requirements, Good Clinical Practice (GCP) requirements, and the applicable regulatory
requirements.
Direct Access - CORRECT ANSWERS Permission to examine, analyze, verify, and
reproduce any records and reports that are important to evaluation of a clinical trial.
Documentation - CORRECT ANSWERS 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 - CORRECT ANSWERS Documents which individually and
collectively permit evaluation of the conduct of a study and the quality of the data produced.
Good Clinical Practice (GCP) - CORRECT ANSWERS 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.
