ISO 20916:2019 体外診断用医療機器—被験者からの検体を使用した臨床パフォーマンス研究—優れた研究実践 | ページ 6

3.1

adverse device effect

adverse event (3.2) related to the use of an IVD medical device under investigation

Note 1 to entry: This definition includes any adverse event resulting from insufficient or inadequate instructions for use, installation, operation, or any malfunction of the IVD medical device under investigation.

Note 2 to entry: This definition includes any event resulting from use error or from intentional misuse of the IVD medical device under investigation.

[SOURCE:ISO 14155:— ¹ , 3.1, modified — Adapted for IVD medical devices.]

3.2

adverse event

ae

any untoward medical occurrence, inappropriate patient management decision, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, with any connection to study related activities, whether or not related to the IVD medical device under investigation

Note 1 to entry: Adverse events can be caused by, for instance, insufficient or inadequate instructions for use, deployment, installation, operation, or any malfunction of the IVD medical device under investigation.

Note 2 to entry: This definition includes the malfunction or deterioration of a device which has not yet caused death or serious injury, but which could lead to death or serious injury.

Note 3 to entry: This definition is not intended to be used in determining whether an event is reportable to a regulatory authority.

Note 4 to entry: For users or other persons, this definition is restricted to events related to investigational (IVD) medical devices.

Note 5 to entry: False negative or false positive results are not considered an adverse event unless in an interventional study, inappropriate patient management decisions are made based on those false results.

3.3

analytical performance

ability of an IVD medical device to detect or measure a particular analyte

[SOURCE:GHTF/SG5/N6:2012]

Note 1 to entry: Analytical performance can include analytical sensitivity (e.g. limit of detection), analytical specificity (e.g. interference, cross-reactivity), accuracy (derived from trueness and precision), linearity, etc.

3.4

analytical performance study

study undertaken to establish or confirm the ability of an IVD medical device to detect or measure a particular analyte

3.5

anticipated serious adverse device effect

effect which by its nature, incidence, severity or outcome has been identified in the risk analysis report

Note 1 to entry: Anticipated serious adverse device effects can also be described in the study protocol, investigator brochure, and subject informed consent, when applicable.

3.6

archived specimen

archived sample

specimen or sample (3.42) that was collected in the past and is obtained from repositories (e.g. tissue banks, commercial vendor collections)

[SOURCE:GHTF/SG5/N8:2012]

3.7

audit

systematic independent examination of activities and documents related to a clinical performance study to determine whether these activities were conducted, and the data recorded, analyzed and accurately reported according to the clinical study performance protocol, standard operating procedures, specified requirements

[SOURCE:ISO 14155:—¹⁾, 3.3, modified — Adapted for IVD medical devices.]

Note 1 to entry: Specified requirements are those described in this document and may include any other applicable requirements such as regulatory provisions.

3.8

blinding

masking

procedure in which one or more parties to the clinical performance study are kept unaware of any information related to the condition or physiological state, treatment, prior test results, demographics, etc., of the individual from whom the specimen for testing was obtained in order to reduce bias

3.9

case report forms

CRFs

set of printed or electronic documents for each subject on which information to be reported to a sponsor is recorded, as required by the clinical performance study protocol

[SOURCE:ISO 14155:—¹⁾, 3.6, modified — Adapted for IVD medical devices.]

3.10

clinical performance of an IVD medical device

ability of an IVD medical device to yield results that are correlated with a particular clinical condition or physiological/pathological process/state in accordance with the intended use (clinical test purpose, target population and intended user)

Note 1 to entry: In accordance with intended use, clinical performance can include expected values, diagnostic sensitivity and diagnostic specificity based on the known clinical condition or physiological/pathological process/state of the individual, and negative and positive predictive values based on the prevalence of the disease.

[SOURCE:GHTF/SG5/N6:2012]

3.11

clinical performance study

study undertaken to establish or confirm the clinical performance of an IVD medical device (3.10)

Note 1 to entry: Testing performed pre-market that is not designed to address clinical performance of an IVD medical device is not considered a clinical performance study (e.g. customer feedback studies, external analytical performance studies, research studies).

[SOURCE:GHTF/SG5/N6:2012]

3.12

clinical performance study protocol

CPSP

document that states the rationale, objectives, design, risk, proposed analysis, methodology, monitoring, conduct and record-keeping of the clinical performance study (3.11)

Note 1 to entry: The CPSP need not be a single document but a series of documents related and referenced to each other for the purpose of creating the CPSP.

[SOURCE:GHTF/SG5/N8:2012]

3.13

clinical performance study report

CPSR

document describing the objectives design, execution, statistical analysis, results and conclusion(s) of a clinical performance study

Note 1 to entry: Some elements of the clinical performance study report can be covered by stand-alone documents that are references in the clinical performance study report.

Note 2 to entry: The CPSR need not be a single document but a series of documents related and referenced to each other for the purpose of creating the CPSR.

[SOURCE:GHTF/SG5/N8:2012]

3.14

contract research organization

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

3.15

device accountability records

records documenting the physical location of all IVD medical devices under investigation, from shipment of the devices to the study site until return or disposal, as well as records documenting the receipt, use, return and disposal of the IVD medical devices under investigation

3.16

device deficiency

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

Note 1 to entry: Device deficiencies include malfunctions, use errors, 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 or the comparator.

[SOURCE:ISO 14155:—¹⁾, 3.19]

3.17

endpoint

principal (primary) or secondary indicator used in a clinical performance study to assess the performance of the IVD medical device (3.24)

Note 1 to entry: For example, endpoints can be statistical measures for performance or clinical events/outcomes.

3.18

ethics committee

EC

independent body whose responsibility it is to review clinical investigations in order to protect the rights, safety (3.41) and well-being of human subjects participating in a clinical investigation

[SOURCE:ISO 14155:—¹⁾, 3.24, modified — Note 1 to entry has been removed.]

3.19

informed consent

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

[SOURCE:ISO 14155:—¹⁾, 3.27]

Note 1 to entry: For the purposes of this document, the permission is typically for providing specimens or participating in a clinical performance study.

Note 2 to entry: The informed consent document lists the risk(s) and benefit(s) to the subject, when applicable.

Note 3 to entry: The information provided can be broad in nature, allowing the specimen to be used for future undetermined studies, or the information can be specific to a particular study.

3.20

intended use

intended purpose

objective intent of the manufacturer regarding the use of a product, process or service as reflected in the specifications, instructions and information provided by the IVD manufacturer

Note 1 to entry: Intended use statements for IVD labelling can include two components: a description of the functionality of the IVD medical device (e.g. an immunochemical measurement procedure for the detection of analyte “x” in serum or plasma), and a statement of the intended medical use of the examination results.

[SOURCE:ISO 18113-1:2009, 3.31, modified]

3.21

interventional clinical performance study

study in which test results obtained during the study can influence patient management decisions and might be used to guide treatments

[SOURCE:GHTF/SG5/N8:2012]

3.22

investigator brochure

compilation of analytical and clinical performance data relevant to the clinical performance study

Note 1 to entry: The investigator brochure includes risk/benefit information of the IVD device under investigation and sampling procedures.

3.23

investigator

sub-investigator

co-investigator

individual member of the investigation study site team designated and supervised by the principal investigator at the study site to perform critical study-related procedures or to make important study-related decisions

3.24

IVD medical device

medical device (3.28) , whether used alone or in combination, intended by the manufacturer for the in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring, or compatibility purposes

Note 1 to entry: IVD medical devices include reagents, calibrators, control materials, specimen receptacles, software and related instruments or apparatus or other articles and are used, for example, for the following test purposes: diagnosis, aid to diagnosis, screening, monitoring, predisposition, prognosis, prediction, determination of physiological status.

[SOURCE:ISO 18113-1:2009, 3.27, modified — Note 1 to entry has been removed, GHTF/SG1/N071:2012.]

3.25

leftover specimen

leftover sample

unadulterated remnants of human derived specimens collected as part of routine clinical practice and after all standard analysis has been performed

Note 1 to entry: Such specimens/samples would be otherwise discarded as there is no remaining clinical need for them.

Note 2 to entry: This can include specimens collected for research or other purposes not connected to the clinical performance study in question.

3.26

legally authorized representative

legally designated representative

individual or 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

[SOURCE:ISO 14155:—¹⁾, 3.32, modified — Note 1 to entry has been deleted, first preferred term has been added and"legally designated representative" has become an admitted term.]

3.27

malfunction

failure of an IVD medical device under investigation to perform in accordance with its intended use (3.20) when used in accordance with the instructions for use or CPSP (3.12)

[SOURCE:ISO 14155:—¹⁾, 3.33, modified — Adapted for IVD medical devices.]

3.28

medical device

[SOURCE:ISO 18113-1:2009, 3.47, modified — Terminology has been slightly changed; GHTF SG1/N071:2012]

3.29

monitor

person, qualified by education, training or experience, responsible for performing the monitoring (3.30) of the clinical performance study

3.30

monitoring

act of reviewing the progress of a clinical performance study and ensuring that it is conducted, recorded and reported in accordance with the CPSP, written procedures, procedures, specified requirements

Note 1 to entry: Specified requirements are those described in this document and may include any other applicable requirements such as regulatory provisions.

3.31

point of enrolment

time at which, following recruitment (3.34) , a subject signs and dates the informed consent form, when required by the ethics committee (3.18) , or otherwise begins participation in the study

[SOURCE:ISO 14155:—¹⁾, 3.38, modified — The definition has been lengthened.]

3.32

principal investigator

qualified person responsible for conducting the clinical performance study at a study site (3.50)

Note 1 to entry: When a clinical performance study is conducted by a team of individuals at a study 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.

3.33

protocol deviation

instance of failure to follow, intentionally or unintentionally, the requirements of the clinical performance study protocol (3.12)

3.34

recruitment

active efforts to identify subjects (3.51) who might be suitable for enrolment in a clinical performance study

3.35

reference measurement procedure

measurement procedure accepted as providing measurement results fit for their use in assessing measurement trueness of measured quantity values obtained from other measurement procedures for quantities of the same kind, in calibration, or in characterizing reference materials

[SOURCE:ISO 15193:2009, 3.7, modified — Notes to entry have been removed.]

3.36

regulatory authority

government agency or other entity that exercises a legal right to control the use or sale of medical devices within its jurisdiction, and can take legal action to ensure that medical devices marketed within its jurisdiction comply with legal requirements

[SOURCE:GHTF/SG1/N68:2012]

3.37

risk

combination of the probability of occurrence of harm and the severity of that harm

[SOURCE:ISO/IEC Guide 51:2014, 3.9]

3.38

risk analysis

systematic use of available information to identify hazards and to estimate the risk (3.37) to study subjects and users of the IVD medical device under investigation

Note 1 to entry: Risk analysis includes examination of different sequences of events that can produce hazardous situations and harm.

Note 2 to entry: For IVDs, the risk analysis should take into consideration risks associated with reporting of inaccurate test results in an interventional study.

[SOURCE:ISO/IEC Guide 51:2014, 3.10, modified — The definition has been adapted for IVDs, Note 1 to entry has been modified and Note 2 to entry has been added.]

3.39

risk assessment

overall process comprising a risk analysis (3.38) and a risk evaluation (3.40)

[SOURCE:ISO/IEC Guide 51:2014, 3.11]

3.40

risk evaluation

process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk

[SOURCE:ISO 14971: — ² , 3.23]

3.41

safety

freedom from unacceptable risk

[SOURCE:ISO/IEC Guide 51:2014, 3.14]

3.42

sample

one or more representative parts taken from a specimen (3.47) , which are intended to provide information

[SOURCE:ISO 18113-1:2009, 3.64, modified — The wording in the definition changed.]

3.43

serious adverse device effect

adverse device effect (3.1) that has resulted in any of the consequences characteristic of a serious adverse event (3.44)

[SOURCE:MEDDEV 2.7.1, rev 4, 2016]

3.44

serious adverse event

SAE