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.
Clinical study design
There are several types of clinical studies, however, the two main types are; Inverventional study; this study
compares the new medical approach to the normal/standard approach. Observational study; the participants may receive
an intervention or procedure, but are not chosen to receive a specific intervention.
A clinical trial is a research project which assigns human participants to one or more intervention(s) in order to
evaluate what effect the intervention has on health outcome.
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.
Concomitant Treatment or medication
Treatment or condition that a patient is taking, which is not investigated in the research project,
which the patient is participating in.
A control group is either; receiving standard treatment, placebo or no treatment.
Clinical Research Associate
A clinical research associate is responsible for collecting and organizing data which is obtained during
the clinical study. Furthermore they ensure that the clinical study stays on track in relation to the
clinical objective of the study and also makes sure that the clinical study complies with the respective
regulations and analyze data. The CRA is appointed by either the Sponsor or by the CRO.
Clinical Research Coordinator
The clinical research coordinator assist the investigator with clinical study related activities,
and is based at the hospital or site where the clinical study is being performed.
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.
Dosage is a defined (prescribed) administration of a specific amount,
number and frequency of doses over a pre-specified period of time.
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.
The ability of the drug or medical intervention to produce the desired outcome
under what would be ideal and controlled circumstances.
Eligibility criteria/inclusion criteria
Eligibility/inculsion criteria must be met by all patients who are enrolled in a
clinical trial. These criteria can e.g. be: age, gender and medical history.
When patients meet all eligibility/inclusion criteria the patient can
participate in the study, and thereby is enrolled in the study.
Exclusion criteria must not be met by any patients who are enrolled in
a clinical trial. These criteria can e.g. be medical history.
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.
Health Insurance Portability and Accountability Act
A law in the United State designed to provide privacy standards to protect patients'
medical records and other health information which is provided to health plans,
doctors, hospitals and other health care providers.
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 process where a health care provider gives information (educates) about the risk,
benefits and alternatives of a given procedure or intervention to a potential patient wishing
to participate in a study. The informed consent must be signed before being enrolled in
the study. However, the decision is totally voluntary.
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.
Open label study
A type of study, where no information is withheld from participants.
This means that both the participant and the researchers knows which
treatment that the patient is receiving.
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.
Over The Counter drugs
Drugs that you can buy without having a prescription e.g. painkillers etc.
A branch of medicine involving medical care of infants, children and adolescents. Pediatrics means
"healer of children".
A patient matching the study who volunteers and is enrolled in the study.
Phases of a trial
Clinical studies are divided into four phases. Each phase has its unique purpose to help researchers
answer various questions and make the procedure as safe as possible for the participant.
Phase 1: The study drug is tested for the first time in small groups with only healthy participants
(20-80 participants) to evaluate safety, determine a safe dose of therapy and identify
possible side effects.
Phase 2: The study drug is given to a larger group of participants with a specific
disease (100-300 participants) to see if the study drug has an effect and to
evaluate the investigational medication’s safety.
Phase 3: The study drug is given to a large group of people (1000-3000) to confirm
the investigational medication’s effect, to monitor side effects, to compare the study
drug with older, existing medications, and to collect information so the study drug is used safely.
Phase 4: This stage is also called post-marketing studies that examined how safe medications
are after the products have entered the market. These examinations will take place after the
study drug has been approved. This stage provides additional information about the drug’s risks,
benefits and very rare side effects.
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.
Placebo is an inert study drug that does not have any medical effect. In clinical studies, the
investigational medication is often compared to placebo to be able to see if the study drug shows
any effect on patients. In some clinical studies, one group of participants receive placebo instead
of the study drug. The groups of participants will not know if they receive placebo or the
investigational medication until the project is completed.
An example of placebo being used would be the following scenario: Two groups diagnosed with the same
disease receive a study drug, since they are participating in a clinical study. One of the two groups
will receive a pill containing the medication, while the other group will receive a pill only containing
sugar. Since the pill containing sugar does not contain medicine, this pill has no medical effect.
When using placebo, the scientists looks for indifferences between the groups to see if the new
study drug worked or not.
Patient reported outcome
Any health-related outcome that is reported by the patient who experienced this outcome.
When participating in a clinical trial a patient reported outcome can e.g be reported
as patient diaries or questionnaires.
The protocol is a detailed written description of how to perform the clinical study.
The protocol contains the aim, design and methods used in relation to the study. Furthermore,
the protocol contains background information for the trial, highlight of scientific research
and questions to address as well as noting how long the trial is expected to last. The aim of
the protocol is to ensure safety of the patients in the trial and secure the integrity of
the data collected.
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.
Patients are allocated to different types of treatment by the use of randomization. Patients are
assigned to different treatment groups by chance. Since the allocation is done by chance, there is
an equal chance of receiving treatment or being allocated to the control group.
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
Patients participating in a clinical study will experience potential risk, which e.g.
could be potentially experiencing uncomfortable or serious side effects.
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.
Before participating in a clinical trial, a potential patient will be screened in order to
determine whether he or she qualifies for the study. Only when the screening period is over,
the patient can be randomized and enrolled in the study.
When a patient match the study, the patient will visit the clinic in order to have a
screening visit performed. Depending on the study, the visit can last 30 minutes to several
hours, where the patient meet the trial coordinater and the principal investigator.
Furthermore, the patient receives a copy of the informed consent form to review.
Side effects are often defined as unwanted actions or impacts related to the experimental treatment.
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.
Standard of care
Standard of care is also described sometimes as standard treatment. It refers to the most
widely used and accepted in relation to a specific medical condition. In some studies the
patient will receive the existing standard-of-care treatment in addition to the treatment
which is being investigated.
When participating patients are at any time allowed to withdraw themselves fom a clinical
trial without giving any reason and without receiving any form of penalty.
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.
Treatment group or experimental group
An experimental group is a group of participants who participate in the clinical study and are
exposed to an experiment/intervention. The opposite of the experimental group is the control group,
which is not exposed to an experiment.
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.
A pre-defined time period in a clinical trial where the patient does not receive active
medication so that all traces of drugs are not within the patients system.