B C D E
G I L M
N O P Q
R S T U
Adverse Drug Reaction (ADR)
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.
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).
Adverse Event (AE)
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).
Amendment (to the protocol)
Applicable Regulatory Requirement(s)
law(s) and regulation(s) addressing the conduct of clinical trials
of investigational products.
Approval (in relation to Institutional Review Boards)
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.
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
declaration of confirmation by the auditor that an audit has taken
written evaluation by the sponsor's auditor of the results of the
that allows reconstruction of the course of events.
procedure in which one or more parties to the trial are kept unaware
of the treatment assignment(s). 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).
Case Report Form (CRF)
printed, optical, or electronic document designed to record all of
the protocol required information to be reported to the sponsor on
each trial subject.
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.
Clinical Trial/Study Report
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 for Structure
and Content of Clinical Study Reports).
investigational or marketed product (i.e., active control), or placebo,
used as a reference in a clinical trial.
Compliance (in relation to trials)
to all the trial-related requirements, Good Clinical Practice (GCP)
requirements, and the applicable regulatory requirements.
of disclosure, to other than authorized individuals, of a sponsor's
proprietary information or of a subject's identity.
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 a contract.
committee that a sponsor may organize to coordinate the conduct of
a multicentre trial.
investigator assigned the responsibility for the coordination of investigators
at different centres participating in a multicentre trial.
Contract Research Organization (CRO)
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.
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, sponsor's 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 sponsor's
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 a trial, and the actions taken.
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).
Good Clinical Practice (GCP)
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
Independent Data-Monitoring Committee (IDMC) (Data and Safety Monitoring
Board, Monitoring Committee, Data Monitoring Committee)
independent data-monitoring committee that may be established by the
sponsor to assess at intervals the progress of a clinical trial, the
safety data, and the critical efficacy endpoints, and to recommend
to the sponsor whether to continue, modify, or stop a trial.
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 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)
independent body (a review board or a committee, institutional, regional,
national, or supranational), constituted of medical/scientific professionals
and non-medical/nonscientific 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 of the
investigator(s), facilities, and the methods and material to be used
in obtaining and documenting informed consent of the trial subjects.
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.
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 subject's decision
to participate. Informed consent is documented by means of a written,
signed and dated informed consent form.
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 sponsor's and/or
contract research organization's (CRO's) facilities, or at other establishments
deemed appropriate by the regulatory authority(ies).
public or private entity or agency or medical or dental facility where
clinical trials are conducted.
Institutional Review Board (IRB)
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
Interim Clinical Trial/Study Report
report of intermediate results and their evaluation based on analyses
performed during the course of a trial.
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
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.
Investigator / Institution
expression meaning "the investigator and/or institution, where
required by the applicable regulatory requirements".
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. Investigator's Brochure)
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.
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).
written report from the monitor to the sponsor after each site visit
and/or other trial-related communication according to the sponsor's
clinical trial conducted according to a single protocol but at more
than one site, and therefore, carried out by more than one investigator.
studies not performed on human subjects.
Opinion (in relation to Independent Ethics Committee)
judgement and/or the advice provided by an Independent Ethics Committee
Original Medical Record
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
written description of a change(s) to or formal clarification of a
Quality Assurance (QA)
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)
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.
process of assigning trial subjects to treatment or control groups
using an element of chance to determine the assignments in order to
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.
Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious
untoward medical occurrence that at any dose:
requires inpatient hospitalization or prolongation of existing hospitalization,
results in persistent or significant disability/incapacity,
a congenital anomaly/birth defect
(see the ICH Guideline for Clinical Safety Data Management: Definitions
and Standards for Expedited Reporting).
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
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).
individual, company, institution, or organization which takes responsibility
for the initiation, management, and/or financing of a clinical trial.
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
Standard Operating Procedures (SOPs)
written instructions to achieve uniformity of the performance of a
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.
An individual who participates in a clinical trial, either as a recipient
of the investigational product(s) or as a control.
Subject Identification Code
unique identifier assigned by the investigator to each trial subject
to protect the subject's identity and used in lieu of the subject's
name when the investigator reports adverse events and/or other trial
location(s) where trial-related activities are actually conducted.
Unexpected Adverse Drug Reaction
adverse reaction, the nature or severity of which is not consistent
with the applicable product information (e.g., Investigator's 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
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.
Well-being (of the trial subjects)
physical and mental integrity of the subjects participating in a clinical