ISO 14155:2020 Terms and Definitions

Question 1

Adverse Device Effect (ADE)

Answer 1

Adverse event related to the use of an investigational medical device
(Note: This includes adverse events resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the investigational medical device. This also includes any event resulting from use error or from intentional misuse of the investigational medical device.)

Question 2

Adverse Event (AE)

Answer 2

Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated

Question 3

Audit

Answer 3

Systematic examination of activities and documents related to a clinical investigation performed by (an) independent person(s), to determine whether these activities were conducted, and the data recorded, analysed and accurately reported, according to the CIP, standard operating procedures, this document and applicable regulatory requirements

Question 4

Audit Trail

Answer 4

Documentation that allows reconstruction of the course of events

Question 5

Blinding / Masking

Answer 5

Procedure in which one or more parties to the clinical investigation are kept unaware of the treatment assignment(s)
(Note: Single blinding usually refers to the subject(s) being unaware of the treatment assignment(s). Double blinding usually refers to the subject(s), investigator(s), monitor and, in some cases, centralized assessors being unaware of the treatment assignment(s))

Question 6

Case Report Form (CRF)

Answer 6

Set of printed, optical or electronic documents for each subject on which information to be reported to the sponsor is recorded, as required by the CIP

Question 7

Certified Copy

Answer 7

Copy (irrespective of the type of media used) of the original record that has been verified (i.e. by a dated signature or by generation through a validated process) to have the same information including data that describe the context, content, and structure, as the original

Question 8

Clinical Investigation

Answer 8

Systematic investigation in one or more human subjects, undertaken to assess the clinical performance, effectiveness or safety of a medical device
(aka “clinical trial” or “clinical study”)

Question 9

Clinical Investigation Plan (CIP)

Answer 9

Document that states the rationale, objectives, design and pre-specified analysis, methodology, organization, monitoring, conduct and record-keeping of the clinical investigation
(aka “protocol”)

Question 10

Clinical Investigation Report

Answer 10

Document describing the design, execution, statistical analysis and results of a clinical investigation

Question 11

Clinical Performance

Answer 11

Behaviour of a medical device and response of the subject(s) to that medical device in relation to its intended use, when correctly applied to appropriate subject(s)

Question 12

Comparator

Answer 12

Medical device, therapy (e.g. active treatment, normal clinical practice), placebo or no treatment, used in the control group in a clinical investigation

Question 13

Computer System

Answer 13

Hardware and software (including associated documents, e.g. user manual) that creates, modifies, maintains, archives, retrieves, or transmits in digital form information related to the conduct of a clinical investigation

Question 14

Contract Research Organization (CRO)

Answer 14

Person or organization contracted by the sponsor to perform one or more of the sponsor’s clinical investigation-related duties and functions

Question 15

Control Group

Answer 15

Group of subjects that receives the comparator

Note: A control group may be concurrent or historical, or subjects may serve as their own control.

Question 16

Coordinating Investigator

Answer 16

Investigator who is appointed by the sponsor to assist in coordinating the work in a multicenter clinical investigation

Question 17

Data Monitoring Committee (DMC)

Answer 17

Independent committee that can be established by the sponsor to assess, at intervals, the progress of the clinical investigation, the safety data or the critical clinical performance or effectiveness endpoints and to recommend to the sponsor whether to continue, suspend, modify, or stop the clinical investigation

Question 18

Deviation

Answer 18

Instance of failure to follow, intentionally or unintentionally, the requirements of the CIP

Question 19

Device Deficiency

Answer 19

Inadequacy of a medical device with respect to its identity, quality, durability, reliability, usability, safety or performance
(Note: Device deficiencies include malfunctions, use errors, and inadequacy in the information supplied by the manufacturer including labelling.)

Question 20

Effectiveness

Answer 20

Achievement of a clinically significant intended result in a defined portion of the target population when the investigational medical device is used within its intended uses and according to its instructions for use, the investigator’s brochure and the CIP, as determined by documented scientific evidence

Question 21

Electronic Record

Answer 21

Combination of text, graphics, data, audio, imaging, or other information in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system

Question 22

Primary Endpoint

Answer 22

Principal indicator(s) used for providing the evidence for clinical performance, effectiveness or safety in a clinical investigation

Question 23

Secondary Endpoint

Answer 23

Indicator(s) used for assessing the secondary objectives of a clinical investigation

Question 24

Ethics Committee (EC)

Answer 24

Independent body whose responsibility it is to review clinical investigations in order to protect the rights, safety, and well-being of human subjects participating in a clinical investigation
(aka “research ethics committee”, “independent ethics committee” or “institutional review board”)

Question 25

Hypothesis

Answer 25

Testable statement, derived from the objective of the clinical investigation to draw a conclusion about this objective, based on a pre-specified statistical test

Question 26

Independent

Answer 26

Not involved in the development of the investigational device or the conduct of a clinical investigation, except for their specifically assigned responsibilities, in order to avoid bias or a conflict of interest

Question 27

Informed Consent

Answer 27

Process by which an individual voluntarily confirms willingness to participate in a particular clinical investigation, after having been informed of all aspects of the investigation that are relevant to the decision to participate

Question 28

Investigation Site

Answer 28

Institution or site where the clinical investigation is carried out
(aka “investigation center”)

Question 29

Investigational Medical Device

Answer 29

medical device being assessed for clinical performance, effectiveness, or safety in a clinical investigation

Question 30

Investigator

Answer 30

Individual member of the investigation site team designated and supervised by the principal investigator at an investigation site to perform clinical investigation-related procedures or to make important clinical investigation-related and medical treatment decisions

Question 31

Investigator’s Brochure (IB)

Answer 31

Compilation of the current clinical and non-clinical information on the investigational medical device(s), relevant to the clinical investigation

Question 32

Legally Designated Representative

Answer 32

Individual, judicial, or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject’s participation in the clinical investigation
(aka “legally authorized representative” or “legally acceptable representative”)

Question 33

Malfunction

Answer 33

Failure of an investigational medical device to perform in accordance with its intended purpose when used in accordance with the instructions for use or CIP, or IB

Question 34

Medical Device

Answer 34

Instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific purpose(s) of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease;
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
— investigation, replacement, modification, or support of the anatomy or of a physiological process;
— supporting or sustaining life;
— control of conception;
— disinfection of medical devices;
— providing information by means of in vitro examination of specimens derived from the human body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means

Question 35

Monitoring

Answer 35

Act of overseeing the progress of a clinical investigation to ensure that it is conducted, recorded, and reported in accordance with the CIP, written procedures, this document, and the applicable regulatory requirements

Question 36

Centralized Monitoring

Answer 36

A remote evaluation of accumulated data and compliance to provide additional monitoring capabilities that can complement or reduce the extent and frequency of on-site monitoring

Question 37

Multicenter Investigation

Answer 37

Clinical investigation that is conducted according to a single CIP and takes place at two or more investigation sites

Question 38

Objective

Answer 38

Main purpose for conducting the clinical investigation

Question 39

Point of Enrollment

Answer 39

Time at which, following recruitment and before any clinical investigation-related procedures are undertaken, a subject signs and dates the informed consent form

Question 40

Principal Investigator

Answer 40

Qualified person responsible for conducting the clinical investigation at an investigation site

Question 41

Quality Assurance

Answer 41

Planned and systematic actions that are established to ensure that the clinical investigation is performed, and the data are generated, documented (recorded), and reported in compliance with this document and the applicable regulatory requirement(s)

Question 42

Quality Control

Answer 42

Operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the clinical investigation-related activities have been fulfilled

Question 43

Randomization

Answer 43

Process of assigning subjects to the investigational medical device or control groups using an established recognized statistical method using an element of chance to determine the unforeseeable assignment in order to reduce bias

Question 44

Recruitment

Answer 44

Active efforts to identify subjects who can be suitable for enrolment into the clinical investigation

Question 45

Serious Adverse Device Effect (SADE)

Answer 45

Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event

Question 46

Serious Adverse Event (SAE)

Answer 46

Adverse event that led to any of the following

a) death,
b) serious deterioration in the health of the subject), users, or other persons as defined by one or more of the following:
1) a life-threatening illness or injury, or
2) a permanent impairment of a body structure or a body function including chronic diseases, or
3) in-patient or prolonged hospitalization, or
4) medical or surgical intervention to prevent life-threatening illness or injury, or permanent impairment to a body structure or a body function,
c) fetal distress, fetal death, a congenital abnormality, or birth defect including physical or mental impairment

Question 47

Serious Health Threat

Answer 47

Signal from any adverse event or device deficiency that indicates an imminent risk of death or a serious deterioration in the health in subjects, users or other persons, and that requires prompt remedial action for other subjects, users or other persons

Question 48

Source Data

Answer 48

All information in original records, certified copies of original records of clinical findings, observations, or other activities in a clinical investigation, necessary for the reconstruction and evaluation of the clinical investigation

Question 49

Source Document

Answer 49

Original or certified copy of printed, optical or electronic document containing source data
(EXAMPLE: Hospital records, laboratory notes, device accountability records, photographic negatives, radiographs, records kept at the investigation site, at the laboratories and at the medico-technical departments involved in the clinical investigation)

Question 50

Sponsor

Answer 50

Individual, company, institution or organization taking responsibility and liability for the initiation and management of a clinical investigation, and arranging the financial setup

Question 51

Subject

Answer 51

Individual who is or becomes a participant in a clinical investigation, either as a recipient of the investigational device or a comparator

Question 52

Unanticipated Serious Adverse Device Effect (USADE)

Answer 52

Serious adverse device effect which by its nature, incidence, severity or outcome has not been identified in the current risk assessment

Question 53

Use Error

Answer 53

User action or lack of user action while using the medical device that leads to a different result than that intended by the manufacturer or expected by the user

Question 54

Validation

Answer 54

Confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled

Question 55

Verification

Answer 55

Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled

Question 56

Vulnerable Subject

Answer 56

Individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response