ISO 14155:2020 人間を対象とした医療機器の臨床調査—優れた臨床実践 | ページ 5

3.1

adverse device effect

ADE

adverse event (3.2) related to the use of an investigational medical device (3.34)

Note 1 to entry: This definition includes adverse events resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction (3.33) of the investigational medical device.

Note 2 to entry: This definition includes any event resulting from use error (3.53) or from intentional misuse of the investigational medical device.

Note 3 to entry: This includes ‘comparator’ (3.12) if the comparator is a medical device.

3.2

adverse event

ae

untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects (3.50) , users or other persons, whether or not related to the investigational medical device (3.29) and whether anticipated or unanticipated

Note 1 to entry: This definition includes events related to the investigational medical device or the comparator (3.12) .

Note 2 to entry: This definition includes events related to the procedures involved.

Note 3 to entry: For users or other persons, this definition is restricted to events related to the use of investigational medical devices or comparators.

3.3

audit

systematic examination of activities and documents related to a clinical investigation (3.8) performed by (an) independent (3.26) 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

3.4

audit trail

documentation that allows reconstruction of the course of events

3.5

blinding

masking

procedure in which one or more parties to the clinical investigation (3.8) are kept unaware of the treatment assignment(s)

Note 1 to entry: Single blinding usually refers to the subject(s) (3.50) being unaware of the treatment assignment(s). Double blinding usually refers to the subject(s), investigator(s) (3.30) , monitor and, in some cases, centralized assessors being unaware of the treatment assignment(s).

Note 2 to entry: A clinical investigation is termed ‘observer blind’, if at least the primary endpoint(s) (3.22) is/are assessed without knowledge of whether an investigational medical device (3.29) or comparator (3.12) has been used to treat a subject.

3.6

case report form

CRF

set of printed, optical or electronic documents for each subject (3.50) on which information to be reported to the sponsor (3.49) is recorded, as required by the CIP

3.7

certified copy

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

3.8

clinical investigation

systematic investigation in one or more human subjects (3.50) , undertaken to assess the clinical performance (3.11) , effectiveness (3.20) or safety of a medical device (3.34)

Note 1 to entry: For the purpose of this document, “clinical trial” or “clinical study” are synonymous with “clinical investigation”.

3.9

clinical investigation plan

CIP

document that states the rationale, objectives (3.37) , design and pre-specified analysis, methodology, organization, monitoring (3.35) , conduct and record-keeping of the clinical investigation (3.8)

Note 1 to entry: For the purpose of this document “protocol” is synonymous with “CIP”. However, protocol has many different meanings, some not related to clinical investigation, and these can differ from country to country. Therefore, the term CIP is used in this document.

3.10

clinical investigation report

document describing the design, execution, statistical analysis and results of a clinical investigation (3.8)

3.11

clinical performance

behaviour of a medical device (3.34) and response of the subject(s) (3.50) to that medical device in relation to its intended use, when correctly applied to appropriate subject(s)

Note 1 to entry: Clinical performance can be defined under national regulations.

3.12

comparator

medical device (3.34) , therapy (e.g. active treatment, normal clinical practice), placebo or no treatment, used in the control group (3.15) in a clinical investigation (3.8)

3.13

computer system

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 (3.8)

3.14

contract research organization

CRO

person or organization contracted by the sponsor (3.49) to perform one or more of the sponsor's clinical investigation-related duties and functions

3.15

control group

group of subjects (3.50) that receives the comparator (3.12)

Note 1 to entry: A control group may be concurrent or historical, or subjects may serve as their own control.

3.16

coordinating investigator

investigator (3.30) who is appointed by the sponsor (3.49) to assist in coordinating the work in a multicentre clinical investigation (3.8)

Note 1 to entry: For the purpose of this document, “national investigator” or “global investigator” are synonymous with “coordinating investigator”.

3.17

data monitoring committee

DMC

independent (3.26) committee that can be established by the sponsor (3.49) to assess, at intervals, the progress of the clinical investigation (3.8) , the safety data or the critical clinical performance (3.11) or effectiveness (3.20) endpoints (3.22) and to recommend to the sponsor whether to continue, suspend, modify, or stop the clinical investigation

Note 1 to entry: For the purpose of this document, “data and safety monitoring board (DSMB)”, “data and safety monitoring committee (DSMC)" or"independent data monitoring committee (IDMC)” are synonymous with DMC.

3.18

deviation

instance of failure to follow, intentionally or unintentionally, the requirements of the CIP (3.9)

3.19

device deficiency

inadequacy of a medical device (3.34) with respect to its identity, quality, durability, reliability, usability, safety or performance

Note 1 to entry: Device deficiencies include malfunctions (3.33) , use errors (3.53) , and inadequacy in the information supplied by the manufacturer including labelling.

Note 2 to entry: This definition includes device deficiencies related to the investigational medical device (3.29) or the comparator (3.12) .

3.20

effectiveness

achievement of a clinically significant intended result in a defined portion of the target population when the investigational medical device (3.29) is used within its intended uses and according to its instructions for use, the investigator’s brochure (3.31) and the CIP (3.9) , as determined by documented scientific evidence

3.21

electronic record

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 (3.13)

3.22

endpoint

<primary> principal indicator(s) used for providing the evidence for clinical performance (3.11) , effectiveness (3.20) or safety in a clinical investigation (3.8)

3.23

endpoint

<secondary> indicator(s) used for assessing the secondary objectives (3.37) of a clinical investigation (3.8)

3.24

ethics committee

EC

independent (3.26) body whose responsibility it is to review clinical investigations (3.8) in order to protect the rights, safety, and well-being of human subjects (3.50) participating in a clinical investigation

Note 1 to entry: For the purposes of this document, “ethics committee” is synonymous with “research ethics committee”, “independent ethics committee” or “institutional review board”. The regulatory requirements pertaining to ethics committees or similar institutions vary by country or region.

3.25

hypothesis

testable statement, derived from the objective (3.37) of the clinical investigation (3.8) to draw a conclusion about this objective, based on a pre-specified statistical test

Note 1 to entry: The primary hypothesis is formulated based on the pre-defined primary endpoint (3.22) and is usually used to calculate the sample size.

3.26

independent

not involved in the development of the investigational device or the conduct of a clinical investigation (3.8) , except for their specifically assigned responsibilities, in order to avoid bias or a conflict of interest

3.27

informed consent

process by which an individual voluntarily confirms willingness to participate in a particular clinical investigation (3.8) , after having been informed of all aspects of the investigation that are relevant to the decision to participate

3.28

investigation site

institution or site where the clinical investigation (3.8) is carried out

Note 1 to entry: For the purpose of this document, “investigation site” is synonymous with “investigation centre”.

3.29

investigational medical device

medical device (3.34) being assessed for clinical performance (3.11) , effectiveness (3.20) , or safety in a clinical investigation (3.8)

Note 1 to entry: This includes medical devices already on the market that are being evaluated for new intended uses, new populations, new materials or design changes.

Note 2 to entry: This includes medical devices already on the market that are being evaluated within their intended use in a post-market clinical investigation (interventional or non-interventional).

Note 3 to entry: For the purpose of this document, the terms “investigational medical device” and “investigational device” are used interchangeably.

3.30

investigator

individual member of the investigation site (3.28) team designated and supervised by the principal investigator (3.39) at an investigation site to perform clinical investigation-related procedures or to make important clinical investigation-related and medical treatment decisions

Note 1 to entry: An individual member of the investigation site team can also be called “sub-investigator” or “co-investigator”.

3.31

investigator's brochure

IB

compilation of the current clinical and non-clinical information on the investigational medical device(s) (3.29) , relevant to the clinical investigation (3.8)

3.32

legally designated representative

individual, judicial, or other body authorized under applicable law to consent, on behalf of a prospective subject (3.50) , to the subject's participation in the clinical investigation (3.8)

Note 1 to entry: “legally authorized representative” or “legally acceptable representative” are other terminologies used under national regulations for “legally designated representative”.

3.33

malfunction

failure of an investigational medical device (3.29) to perform in accordance with its intended purpose when used in accordance with the instructions for use or CIP, or IB

3.34

medical device

[SOURCE:ISO 13485:2016, 3.11]

3.35

monitoring

act of overseeing the progress of a clinical investigation (3.8) to ensure that it is conducted, recorded, and reported in accordance with the CIP, written procedures, this document, and the applicable regulatory requirements

Note 1 to entry: Centralized monitoring is 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.

3.36

multicentre investigation

clinical investigation (3.8) that is conducted according to a single CIP and takes place at two or more investigation sites (3.28)

3.37

objective

main purpose for conducting the clinical investigation (3.8)

3.38

point of enrolment

time at which, following recruitment (3.43) and before any clinical investigation-related procedures are undertaken, a subject (3.50) signs and dates the informed consent (3.27) form

3.39

principal investigator

qualified person responsible for conducting the clinical investigation (3.8) at an investigation site (3.28)

Note 1 to entry: If a clinical investigation is conducted by a team of individuals at an investigation site, the principal investigator is responsible for leading the team.

Note 2 to entry: Whether this is the responsibility of an individual or an institution can depend on national regulations.

3.40

quality assurance

planned and systematic actions that are established to ensure that the clinical investigation (3.8) is performed, and the data are generated, documented (recorded), and reported in compliance with this document and the applicable regulatory requirement(s)

3.41

quality control

operational techniques and activities undertaken within the quality assurance (3.40) system to verify that the requirements for quality of the clinical investigation-related activities have been fulfilled

3.42

randomization

process of assigning subjects (3.50) to the investigational medical device (3.29) or control groups (3.15) using an established recognized statistical method using an element of chance to determine the unforeseeable assignment in order to reduce bias

3.43

recruitment

active efforts to identify subjects (3.50) who can be suitable for enrolment into the clinical investigation (3.8)

3.44

serious adverse device effect

SADE

adverse device effect (3.1) that has resulted in any of the consequences characteristic of a serious adverse event (3.45)

3.45

serious adverse event

SAE