ISO 11249:2018
(Main)Copper-bearing intrauterine contraceptive devices — Guidance on the design, execution, analysis and interpretation of clinical studies
Copper-bearing intrauterine contraceptive devices — Guidance on the design, execution, analysis and interpretation of clinical studies
ISO 11249:2018 provides guidance on the design and conduct of clinical studies to determine the performance characteristics of new intrauterine devices. It also provides advice on the analysis of data when the study is completed, as well as interpretation of these results by manufacturers, researchers and regulatory bodies. ISO 11249:2018 is intended to ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results, and to assist sponsors, monitors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices. Certain clinical trial concerns are not addressed in this document, including subject compensation, confidentiality of subjects and their records, use of local ethics committees, etc. These and many other clinical trial design issues are covered in great detail in ISO 14155.
Dispositif intra-utérin au cuivre à but contraceptif — Recommandations relatives à la méthodologie, la réalisation, l'analyse et l'interprétation des résultats des études cliniques
General Information
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 11249
First edition
2018-02
Copper-bearing intrauterine
contraceptive devices — Guidance on
the design, execution, analysis and
interpretation of clinical studies
Dispositif intra-utérin au cuivre à but contraceptif —
Recommandations relatives à la méthodologie, la réalisation,
l'analyse et l'interprétation des résultats des études cliniques
Reference number
©
ISO 2018
© ISO 2018
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ii © ISO 2018 – All rights reserved
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Planning an IUD trial — Good clinical practice . 6
5 Ethics . 6
5.1 General . 6
5.2 Ethics of IUD trials . 6
5.3 Informed consent . 6
5.3.1 General. 6
5.3.2 Process of obtaining informed consent . 7
5.3.3 Information to be provided to the subject . 7
6 Identification and description of the investigational device . 7
7 Preliminary investigations and justification for the design of the clinical investigation .7
7.1 Literature review . 7
7.2 Preclinical testing . 8
7.3 Previous clinical experience . 8
7.4 Investigational device and clinical investigation risks and benefits . 8
8 Objectives and hypotheses of the clinical investigation . 8
9 Design of the clinical investigation . 9
9.1 General . 9
9.2 Investigational device(s) and comparator(s) .13
9.3 Subjects .14
9.4 Procedures .15
9.5 Statistical considerations .16
10 Adverse events, adverse device effects and non-medical complaints .18
11 Early termination or suspension of the clinical investigation .18
12 Publication policy .18
Annex A (informative) Exclusion and inclusion criteria for IUD trials .19
Annex B (informative) Timing of insertion of IUD: When can an IUD be inserted? .21
Bibliography .22
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO’s adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www .iso .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 157, Non-systemic contraceptives and STI
barrier prophylactics.
iv © ISO 2018 – All rights reserved
Introduction
This clinical study guidance is intended to help in the design, execution, analysis, and interpretation of
clinical studies conducted in accordance with the requirements of ISO 7439.
Intrauterine devices (IUD) are highly effective at preventing pregnancy. A new device aims at maintaining
or improving the efficacy of intrauterine contraception and/or reducing the side effects associated with
IUDs, such as excessive menstrual bleeding. Trials evaluating new or modified IUDs should be conducted
to the highest standards and this guidance will help those preparing for an IUD trial.
This guidance is based on the structure and content of a clinical investigation plan (CIP) as described in
ISO 14155 to assist in the writing of a CIP and includes sections of the CIP that are of special relevance
to IUD trials.
This guidance also draws on the experience gained in preparing the Cochrane systematic review of
trials of copper-containing IUDs, which has been used to inform the updating of the WHO/UNFPA
Specification for TCu380A IUD.
It is important that persons designing, running, and analysing clinical studies of new IUDs are familiar
with all relevant standards for research designed to protect the rights, safety and well-being of human
subjects.
This guidance should be read in conjunction with ISO 14155.
Clinical studies are also subject to local regulations and, in most countries, require prior approval from
the local regulatory body.
INTERNATIONAL STANDARD ISO 11249:2018(E)
Copper-bearing intrauterine contraceptive devices —
Guidance on the design, execution, analysis and
interpretation of clinical studies
1 Scope
This document provides guidance on the design and conduct of clinical studies to determine the
performance characteristics of new intrauterine devices. It also provides advice on the analysis of data
when the study is completed, as well as interpretation of these results by manufacturers, researchers
and regulatory bodies.
It is intended to ensure the scientific conduct of the clinical investigation and the credibility of the
clinical investigation results, and to assist sponsors, monitors, investigators, ethics committees,
regulatory authorities and other bodies involved in the conformity assessment of medical devices.
Certain clinical trial concerns are not addressed in this document, including subject compensation,
confidentiality of subjects and their records, use of local ethics committees, etc. These and many other
clinical trial design issues are covered in great detail in ISO 14155.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at https:// www .iso .org/ obp
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 subject
...
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