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FDA MHRA JSQA CRO List Clinical Trials Clinical Research

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1. GLOSSARY
1.1

Adverse

Drug

Reaction

(ADR)

In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the
therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to
any dose should be considered adverse drug reactions. The phrase responses to a medicinal product means that a
causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e. the
relationship

cannot

be

ruled

out.

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 (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited
Reporting).
1.2

Adverse

Event (AE)

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. An adverse event (AE) can
therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease
temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal
(investigational) product (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards
for Expedited Reporting).
1.3

Amendment

See Protocol Amendment.

to

the

protocol

1.4

Applicable

Regulatory

Requirement(s)

Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products.
1.5

Approval

(in

relation

to

Institutional

Review

Boards)

The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution
site within the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and the applicable
regulatory requirements.
1.6

Audit

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, sponsors standard operating procedures (SOPs), Good Clinical Practice (GCP), and the
applicable regulatory requirement(s).
1.7

Audit

Certificate

A declaration of confirmation by the auditor that an audit has taken place.

Audit

Report

A written evaluation by the sponsors auditor of the results of the audit.

Audit

Trail

Documentation that allows reconstruction of the course of events.

Blinding/Masking

A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Singleblinding 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).
1.11

Case

Report

Form

(CRF)

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.
1.12

Clinical

Trial/Study

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. The terms clinical trial and clinical study are
synonymous.
1.13

Clinical

Trial/Study

Report

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 analyses are fully integrated into a single

report

(see

the

ICH

Guideline

1.14

for

Structure

and

Content

of

Clinical

Comparator

Study

Reports).
(Product)

An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial.
1.15

Compliance

(in

relation

to

trials)

Adherence to all the trial-related requirements, Good Clinical Practice (GCP) requirements, and the applicable
regulatory requirements.
1.16

Confidentiality

Prevention of disclosure, to other than authorized individuals, of a sponsors proprietary information or of a

Contract

A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on
delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve
as

the

basis

of

contract.
1.18

Coordinating

Committee

A committee that a sponsor may organize to coordinate the conduct of a multicentre trial.
1.19

Coordinating

Investigator

An investigator assigned the responsibility for the coordination of investigators at different centres participating in a
multicentre trial.
1.20

Contract

Research

Organization

(CRO)

A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a
sponsors trial-related duties and functions.
1.21

Direct

Access

Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a
clinical trial. Any party (e.g., domestic and foreign regulatory authorities, sponsors monitors and auditors) with
direct

access

should

take all reasonable precautions within the constraints of the applicable regulatory requirement(s) to maintain the
confidentiality of subjects identities and sponsors proprietary information.
1.22

Documentation

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
actions taken.

trial,

and

the

1.23

Essential

Documents

Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the
data produced (see 8. Essential Documents for the Conduct of a Clinical Trial).
1.24

Good

Clinical

Practice

(GCP)

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.

Monitoring Board, Monitoring Committee, Data Monitoring Committee) An independent data-monitoring

Impartial

Witness

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 subjects legally acceptable representative cannot read, and
who

reads

the

informed

consent form and any other written information supplied to the subject.
1.27

Independent

Ethics

Committee

(IEC)

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 favourableopinion 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.
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.
1.28

Informed

Consent

A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after
having been informed of all aspects of the trial that are relevant to the subjects decision to participate. Informed
consent

is

documented

by

means of a written, signed and dated informed consent form.

Inspection

The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any
other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the

site of the trial, at the sponsors and/or contract research organizations (CROs) facilities, or at other establishments
deemed appropriate by the regulatory authority(ies).
1.30
Any

Institution
public

or

private

entity

or

agency

or

(medical)
medical

or

dental

facility

where

clinical

trials are conducted.

Institutional

Review

Board

(IRB)

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 subjects.
1.32

Interim

Clinical

Trial/Study

Report

A report of intermediate results and their evaluation based on analyses performed during the course of a trial.
1.33

Investigational

Product

A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial,
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.
1.34

Investigator

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 investigator. See
also Subinvestigator.
1.35

Investigator

Institution

An expression meaning the investigator and/or institution, where required by the applicable regulatory
requirements.
1.36

Investigators

Brochure

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 (see 7. Investigators Brochure).
1.37

Legally

Acceptable

Representative

An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective
subject, to the subjects participation in the clinical trial.
1.38

Monitoring

The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in

accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the
applicable regulatory requirement(s).
1.39

Monitoring

Report

A written report from the monitor to the sponsor after each site visit and/or other trial-related communication
according to the sponsors SOPs.
1.40

Multicentre

Trial

A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more
than one investigator.
1.41

Nonclinical

Study

Biomedical studies not performed on human subjects.

Opinion

(in

relation

to

Independent

Ethics

Committee)

The judgement and/or the advice provided by an Independent Ethics Committee (IEC).
1.43

Original

Medical

Record

See Source Documents.

Protocol

A document that describes the objective(s), design, methodology, statistical considerations, and organization of a
trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other
protocol referenced documents. Throughout the ICH GCP Guideline the term protocol refers to protocol and
protocol amendments.
1.45

Protocol

Amendment

A written description of a change(s) to or formal clarification of a protocol.

Quality

Assurance

(QA)

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(s).
1.47

Quality

Control

(QC)

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.
1.48

Randomization

The process of assigning trial subjects to treatment or control groups using an element of chance to determine the
assignments in order to reduce bias.

1.49

Regulatory

Authorities

Bodies having the power to regulate. In the ICH GCP guideline the expression Regulatory Authorities includes the
authorities that review submitted clinical data and those that conduct inspections (see 1.29). These bodies are
sometimes referred to as competent authorities.
1.50

Serious

Adverse

Event

(SAE)

or

Serious

Adverse

Drug

(Serious

ADR)

Any

untoward

medical

occurrence

that

results

at

any

in

Reaction

death,

is
requires

inpatient

results

hospitalization
in

dose:

life-threatening,
or

prolongation

persistent

or

of

existing

significant

hospitalization,
disability/incapacity,

or
-

is

congenital

anomaly/birth

defect

(see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).
1.51

Source

Data

All information in original records and certified copies of original records of clinical findings, observations, or other
activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in
source documents (original records or certified copies).
1.52

Source

Documents

Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes,
memoranda, subjects diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated
instruments,

copies

or

transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or
magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical
departments involved in the clinical trial).
1.53

Sponsor

An individual, company, institution, or organization which takes responsibility for the initiation, management,
and/or financing of a clinical trial.
1.54

Sponsor-Investigator

An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate
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 corporation or an agency). The obligations of a sponsor-investigator include
both those of a sponsor and those of an investigator.

1.55

Standard

Operating

Procedures

(SOPs)

Detailed, written instructions to achieve uniformity of the performance of a specific function.

Subinvestigator

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 to make important trial-related decisions (e.g., associates, residents,
research

fellows).

See

also

Investigator.
1.57

Subject/Trial

Subject

An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control.
1.58

Subject

Identification

Code

A unique identifier assigned by the investigator to each trial subject to protect the subjects identity and used in lieu
of the subjects name when the investigator reports adverse events and/or other trial related data.
1.59

Trial

Site

The location(s) where trial-related activities are actually conducted.

Unexpected

Adverse

Drug

Reaction

An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g.,
Investigators Brochure for an unapproved investigational product or package insert/summary of product
characteristics for an approved product) (see the ICH Guideline for Clinical Safety Data Management: Definitions
and Standards for Expedited Reporting).
1.61

Vulnerable

Subjects

Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether
justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a
hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as
medical, pharmacy, dental, and nursing students, 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, nomads, refugees, minors, and those incapable of
giving consent.
1.62

Well-being

(of

the

The physical and mental integrity of the subjects participating in a clinical trial.

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trial

subjects)