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Flashcards in Common Clinical Trial Terms Deck (24):

Adverse Event

side effect


Adverse Drug Reaction

noxious and unintended response associated
with the use of a drug in humans.



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(


blinded study/masked study

study which subject not know if receiving either the drug or placebo


certified copy

A copy of original information
that has been verified as indicated by a dated
signature, as an exact copy having all of the
same attributes and information as the original.


case report form

A printed, optical,
or electronic document designed to record
all of the protocol-required information to be
reported to the sponsor for each trial subject.


curriculum vitae

. Document that
outlines a person’s educational and professional


Declaration of Helsinki

i. A set of
recommendations or basic principles that
guide medical doctors in the conduct of
biomedical research involving human subjects.
it was originally adopted by the 18th World
Medical assembly


double-blind study

a study in which neither
the subject nor the investigator nor the research
team interacting with the subject or data during
the trial knows what treatment a subject is


electronic medical record

electronic record for healthcare providers within
one healthcare organization to create, store,
and use clinical information for patient care


exclusion criteria

List of characteristics in
a protocol, any one of which may exclude a
potential subject from participation in a study


good clinical practice

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


institutional review board

independent body constituted of medical,
scientific, and non-scientific members, whose
responsibility it 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 of the
methods and material to be used in obtaining
and documenting informed consent of the trial


electronic data capture

The process
of collecting clinical trial data into a permanent
electronic form


inclusion criteria

The criteria in a protocol
that prospective subjects must meet to be
eligible for participation in a study


independent ethics committee

An independent body (a review board or a
committee, institutional, regional, national,
or supranational) constituted of medical/
scientific professionals and non-scientific
members, whose responsibility it is to ensure the
protection of the rights, safety, and well-being
of human subjects involved in a trial and to
provide public assurance of that protection by,
among other things, reviewing and approving/
providing favorable opinion on the trial
protocol, the suitability of the investigator(s),
facilities, and the methods and material
to be used in obtaining and documenting
informed consent of the trial subjects



An individual who actually
conducts a clinical investigation (i.e., under
whose immediate direction the test article is
administered or dispensed to, or used involving
a subject, or, in the event of an investigation
conducted by a team of individuals, is the
responsible leader of that team


investigator’s brochure

A compilation
of the clinical and non-clinical data on the
investigational product(s) that is relevant to the
study of the investigational product(s) in human


investigational product

A pharmaceutical
form of an active ingredient or placebo being
tested or used as a reference in a clinical


legally acceptable representative

individual or juridical or other body authorized
under applicable law to consent, on behalf
of a prospective subject, to the subject’s
participation in the clinical trial



. Study of the processes of
bodily absorption, distribution, metabolism, and
excretion (ADME) of medicinal products.


quality assurance

All those planned
and systematic actions that are established to
ensure that the trial is performed and the data are
generated, documented (recorded), and reported
in compliance with good clinical practice (GCP)
and the applicable regulatory requirement


quality control

The operational
techniques and activities undertaken within
the quality assurance system to verify that the
requirements for quality of the trial related
activities have been fulfilled


serious adverse event (SAE) or serious
adverse drug reaction (serious ADR).

Any untoward medical occurrence that at
any dose: results in death, is life threatening,
requires inpatient hospitalization or
prolongation of existing hospitalization, results
in persistent or significant disability/ incapacity,
or is a congenital anomaly/ birth defect