OP ACRP CP UPDATED 2025-2026
T
EXAM WITH QUESTIONS & ELABORATE
ANSWERS 100% CORRECT
dverse Drug Reaction (ADR) - CORRECT ANSWER-All noxious and unintended
A
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
dverse Event (AE) - CORRECT ANSWER-Any untoward medical occurrence in a
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)
udit - CORRECT ANSWER-A systematic and independent examination of trial related
A
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).
udit Trail - CORRECT ANSWER-Documentation that allows reconstruction of the
A
course of events.
linding/Masking - CORRECT ANSWER-A procedure in which one or more parties to
B
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)
ase Report Form (CRF) - CORRECT ANSWER-A printed, optical, or electronic
C
document designed to record all of the protocol required information to be reported to
the sponsor on each trial subject.
, linical Trial/Study - CORRECT ANSWER-Any investigation in human subjects
C
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.
linical Trial/Study Report - CORRECT ANSWER-A written description of a trial/study
C
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)
omparator (Product) - CORRECT ANSWER-An investigational or marketed product
C
(i.e., active control), or placebo, used as a reference in a clinical trial.
ompliance (in relation to trials) - CORRECT ANSWER-Adherence to all the
C
trial-related requirements, Good Clinical Practice (GCP) requirements, and the
applicable regulatory requirements.
irect Access - CORRECT ANSWER-Permission to examine, analyze, verify, and
D
reproduce any records and reports that are important to evaluation of a clinical trial.
ocumentation - CORRECT ANSWER-All records, in any form (including, but not
D
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.
ssential Documents - CORRECT ANSWER-Documents which individually and
E
collectively permit evaluation of the conduct of a study and the quality of the data
produced.
ood Clinical Practice (GCP) - CORRECT ANSWER-A standard for the design,
G
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 - CORRECT 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
T
EXAM WITH QUESTIONS & ELABORATE
ANSWERS 100% CORRECT
dverse Drug Reaction (ADR) - CORRECT ANSWER-All noxious and unintended
A
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
dverse Event (AE) - CORRECT ANSWER-Any untoward medical occurrence in a
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)
udit - CORRECT ANSWER-A systematic and independent examination of trial related
A
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).
udit Trail - CORRECT ANSWER-Documentation that allows reconstruction of the
A
course of events.
linding/Masking - CORRECT ANSWER-A procedure in which one or more parties to
B
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)
ase Report Form (CRF) - CORRECT ANSWER-A printed, optical, or electronic
C
document designed to record all of the protocol required information to be reported to
the sponsor on each trial subject.
, linical Trial/Study - CORRECT ANSWER-Any investigation in human subjects
C
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.
linical Trial/Study Report - CORRECT ANSWER-A written description of a trial/study
C
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)
omparator (Product) - CORRECT ANSWER-An investigational or marketed product
C
(i.e., active control), or placebo, used as a reference in a clinical trial.
ompliance (in relation to trials) - CORRECT ANSWER-Adherence to all the
C
trial-related requirements, Good Clinical Practice (GCP) requirements, and the
applicable regulatory requirements.
irect Access - CORRECT ANSWER-Permission to examine, analyze, verify, and
D
reproduce any records and reports that are important to evaluation of a clinical trial.
ocumentation - CORRECT ANSWER-All records, in any form (including, but not
D
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.
ssential Documents - CORRECT ANSWER-Documents which individually and
E
collectively permit evaluation of the conduct of a study and the quality of the data
produced.
ood Clinical Practice (GCP) - CORRECT ANSWER-A standard for the design,
G
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 - CORRECT 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
