ISO 11249:2018 銅含有子宮内避妊具—臨床研究の設計、実行、分析、および解釈に関するガイダンス | ページ 6

3.1

adverse device effect

ADE

adverse event (3.2) related to the use of a medical device (3.27)

Note 1 to entry: This includes any adverse event resulting from insufficiencies or inadequacies in the instructions for use, the deployment, the implantation, the installation, the operation, or any malfunction (3.26) of the medical device.

Note 2 to entry: This includes any event that is a result of a use error or intentional misuse.

3.2

adverse event

ae

any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects (3.35) , users or other persons whether or not related to the investigational device (3.25)

Note 1 to entry: This includes events related to the investigational device or the comparator (3.10) .

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

Note 3 to entry: For users or other persons, this is restricted to events related to the investigational device.

3.3

audit

systematic examination of clinical investigation (3.6) related activities and documents performed by an independent entity not involved in the conduct of the clinical investigation

Note 1 to entry: The examination will determine whether the clinical investigation related activities were conducted, and the data were recorded, analysed and accurately reported, according to the clinical investigation plan (3.7) , standard operating procedures, this document and applicable regulatory requirements.

3.4

blinding/masking

procedure in which one or more parties to the clinical investigation (3.6) are kept unaware of the treatment assignment(s)

Note 1 to entry: Single-blinding usually refers to the subject(s) (3.35) being unaware of the treatment assignment(s). Double-blinding usually refers to the subject(s), clinical investigator(s), monitor, and, in some cases, centralized assessors being unaware of the treatment assignment(s).

3.5

case report form

CRF

set of printed, optical or electronic documents for each subject (3.35) on which information to be reported to the sponsor (3.34) is recorded as required by the CIP

Note 1 to entry: There may be more than one case report form per subject.

3.6

clinical investigation

systematic investigation in or on one or more human subjects (3.35) , undertaken to assess the safety and/or efficacy of a medical device (3.27)

Note 1 to entry: “Clinical trial” or “clinical study” are synonymous with “clinical investigation”.

3.7

clinical investigation plan

CIP

document that states the rationale, objectives (3.28) , design and proposed analysis, methodology, monitoring, conduct and record-keeping of the clinical investigation (3.6)

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

3.8

clinical investigation report

written document summarizing the design, execution, statistical analysis and results of a clinical investigation (3.6)

3.9

clinical performance

behaviour of a medical device (3.27) and/or the response of the subject (3.35) to that medical device in relation to its intended use when correctly applied to appropriate subjects

3.10

comparator

medical device (3.27) , therapy (e.g. active control), placebo or no treatment, used in the reference group in a clinical investigation (3.6)

3.11

deviation

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

3.12

ectopic pregnancy

pregnancy located outside the uterine cavity

3.13

primary end point

indicator to assess the primary hypothesis (3.17) of a clinical investigation (3.6)

Note 1 to entry: There might be more than one primary end point.

3.14

secondary end point

indicator to assess the secondary hypotheses (3.17) of a clinical investigation (3.6)

Note 1 to entry: There might be more than one secondary end point.

3.15

ethics committee

EC

independent body whose responsibility is to review clinical investigations (3.6) , protocols and procedures in order to protect the rights, safety and well-being of human subjects (3.35) 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 can differ by country or region.

3.16

expulsion

inadvertent movement of the IUD into or from the vagina, including partial expulsion, requiring removal of the IUD from the cervix

3.17

hypothesis

testable biostatistical statement, derived from the study objective (3.28) , for evaluating the investigational device (3.25) safety and/or performance

Note 1 to entry: The hypothesis is used to design the clinical investigation (3.6) and stipulates the statistic(s) used to accept or reject the results of the clinical investigation.

Note 2 to entry: The primary hypothesis is the determinant of the investigational device safety and/or performance parameters and is usually used to calculate the sample size. Secondary hypotheses concerning other points of interest can also be evaluated.

3.18

independent party

party not involved in the conduct of a clinical investigation (3.6) , except for their specifically assigned responsibilities in order to avoid bias or a conflict of interest

3.19

informed consent process

process by which an individual is asked to voluntarily participate in a clinical investigation (3.6) having been provided with information about the clinical investigation

Note 1 to entry: Informed consent is documented by means of a written, signed and dated informed consent form.

3.20

intrauterine pregnancy

normally sited pregnancy within the uterine cavity

3.21

insertion instrument

instrument designed to place an IUD in the uterine cavity

3.22

intrauterine contraceptive device

IUD

device placed in the uterine cavity for the purpose of preventing pregnancy

Note 1 to entry: The abbreviation IUCD may be used in some publications.

3.23

investigator

any individual member of the investigation site (3.24) team designated and supervised by the principal investigator at an investigation site to perform critical clinical investigation-related procedures and/or to make important clinical investigation-related decisions

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

3.24

investigation site

institution or site where the clinical investigation (3.6) is carried out

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

3.25

investigational device

medical device (3.27) being assessed for safety and performance in a clinical investigation (3.6)

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

3.26

malfunction

failure of a device to perform in accordance with its intended purpose when used in accordance with the instructions for use or CIP

3.27

medical device

3.28

objective

major purpose(s) for conducting the clinical investigation (3.6)

3.29

perforation

puncture of the uterus, as may be caused by a uterine sound or insertion tube or by an intrauterine contraceptive device (3.22)

3.30

point of enrolment

date at which, following recruitment (3.31) and signing and dating the informed consent form, a subject (3.35) is enrolled in a study

3.31

recruitment

active efforts to identify subjects (3.35) who might be suitable for enrolment into the clinical investigation (3.6)

3.32

serious adverse device effect

SADE

adverse device effect (3.1) that has resulted in any of the consequences characteristic of a serious adverse event (3.33)

3.33

serious adverse event

SAE