Clinical trial glossary for words and terms that are often used.
Any unexpected and unfavorable and unintended sign (including abnormal
laboratory finding), symptom or disease temporally associated with the use of a medicinal
product, whether or not related to the medicinal (investigational) product.
A process, where one or more parties within the clinical trial are not aware of the treatment the
patients are assigned. Blinding is performed to avoid bias. E.g. if a patient know that he/she is
getting the active treatment, this could skew the results, so that it might seem better to get the
active drug, than it actually is.
Adherence to all the trial-related requirements. Both considering that the clinic follows the GCP
requirements, and the applicable regulatory requirements. Furthermore, compliance can be used in
relation to patients adhering to the study schedule.
Case Report Form
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.
Clinic Research Organization
A person or an organization (commercial, academic, or other) contracted by the sponsor to perform
one or more of a
sponsor's trial-related duties and functions.
Two parties are blinded in the clinical trial. Often this is the the patient and the persons
performing the trial
(monitors) and sometimes even the persons analysing the data from the trial.
Food and Drug Administration
Only relevant in USA. They decide if new medical products can enter the market.
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.
Good Documentation Practice
International ethical and scientific quality standard for designing, conducting, monitoring,
analyzing and reporting studies.
GCP ensures that the data from clinical trials are credible and accurate, making sure that the
subjects rights and
confidentiality is protected.
In general terms also known as "copy drugs", meaning that the drug contains the same active
ingredient as the original
drug, but the excipients can vary from the original drug. This is the reason for why some patients
cannot use generic
Good Laboratory Practice
A quality system of management controls for research laboratories and organizations to ensure the
consistency, reliability, reproducibility, quality and integrity of chemical (including
pharmaceuticals) non clinical
safety tests; from physio-chemical properties through acute chronic toxicity tests.
Good Manufacturing Practice
The GMP guidelines provide the minimum requirements which a manufacturer must meet to assure that
their products are
consistently high in quality, from batch to batch for their intended user. The requirements for the
GMP might vary in
relation to the different industry (e.g. food, cosmetics, pharmaceutical products and medical
devices). The main purpose
of GMP is to avoid that harm is done to the end user.
A compilation of the clinical and nonclinical data on the investigational product(s) which is
relevant to the study of
the investigational product(s) in human subjects.
International Conference on Harmonisation
A regulatory/industry project to improve the efficiency of the process for developing and
registering new products in
Europe, Japan and USA.
Independent Ethics Committee
An independent body (a review board or a committee institutional, regional, national, or
supranational), constituted of
medical professionals and non-medical 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 favourable opinion on, the trial protocol, the suitability
investigator(s), facilities, and the methods and material to be used in obtaining and
documenting informed consent of the trial subjects. The legal status, composition, function,
operations and regulatory
requirements pertaining to Independent Ethics Committees may differ among countries, but should
allow the Independent
Ethics Committee to act in agreement with GCP as described in this guideline.
Test made on cultures and in an artificial enviroment - not tested in humans, more like tested in
petri dishes at the
Test made in living animals and/or human systems.
A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted
by a team of
individuals at a trial site, the investigator is the responsible leader of the team and may be
called the principal
A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a
including a product with a marketing authorization when used or assembled
(formulated or packaged) in a way different from the approved form, or when used for an unapproved
indication, or when
used to gain further information about an approved use.
Institutional Review Board
An independent body constituted of medical, scientific, and non-scientific members, whose
responsibility 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
amendments and of the
methods and material to be used in obtaining and documenting informed consent of the trial subject.
A clinical trial conducted according to a single protocol but at more than one site, and therefore,
carried out by more
than one investigator.
Over The Counter drugs
Drugs that you can buy without having a prescription e.g. painkillers etc.
The person(s) in charge of a clinical trial or a scientific research grant. The principal
investigator prepares and
carries out the clinical trial protocol (plan for the study) or research paid for by the grant. The
investigator also analyzes the data and reports the results of the trial or grant research.
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 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.
The process of assigning trial subjects to treatment or control groups using an element of chance to
assignments in order to reduce bias.
Serious Adverse Event
A SAE in human drug trials is defined as any untoward medial occurence that any dose; results in
life-threatening, requres inpatient hospitalization or causes prolongation of existing
hospitalization , results in
persistent or significant disability/incapacity, is a congenital anomality/birth defact, or requires
prevent permanent impairment or damage.
A procedure in which one or more parties to the trial are kept unaware of the treatment
Single-blinding usually refers to the subject(s), investigator(s), monitor, and, in some cases, data
unaware of the treatment assignment(s). Often, at a single blinded trial, it is the patient who does
not know which
medication they recieve.
Site / Clinic
The site is were the patient participate in the clinical trial. This is were all data is collected
e.g. Blood samples,
CT scan, X-ray etc.
Site Management Organisation
Organisation thats finds and manage performing of clinical sites.
Standard Operating Procedure
Detailed, written intructions to achieve uniformity of the performance of a specific function.
An individual, company, institution, or organization which takes responsibility for the initiation,
financing of a clinical trial.
An individual who both initiates and conducts, alone or with others, a clinical trial, and under
direction the investigational product is administered to, dispensed to, or used by a subject. The
term does not include
any person other than an individual (e.g. it does
not include a coroperation or an agency). The obligations of a sponsor-investigator include both
those of a sponsor and
those of an investigator.
Any individual member of the clinical trial team designated and
supervised by the investigator at a trial site to perform critical trial-related procedures and/or
trial-related decisions (e.g. associates, residents, research fellows).
A knowledge field that focuses on research and development of treatments for diseases and pathologic
findings, as well
as prevention of conditions that negatively impact the health of an individual. The different TA's
Patiro has are e.g.
cardiovascular disease, endocrine/hormonal diseases etc.
Unexpected Adverse Drug Reaction
An adverse reaction, the nature or severity of which is not consistent with the applicable product
Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the
justified or not, of benefits associated with participation, or a retaliatory response from senior
members of a hierachy
in case of refusal to participate.
Examples are members of a group with a hierarchial structure, such as medical, pharmacy, dental and
subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of
the armed forces and
persons kept in
detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing
homes, unemployed or
impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons,
minors and those incapable of giving consent.
An orphan disease is a disease which has not been "adopted" by the pharmaceutical industry. Meaning
that no treatment
has been developed, often due to the fact that it provides little financial incentive for the privat
sector to make and
market new medications to prevent it.
A rare disease affects a small percentage of the population. However, there is not single widely
accepted definition for
rare diseases, so a specific cutoff has not been established. Often, the rare disease is genetic and
many rare diseases
appear early in life, and about 30 % of children with rare diseases will die before reaching 5 years
A branch of medicine involving medical care of infants, children and adolescents. Pediatrics means
"healer of children".