ISO 11249:2018

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

• Status: Published
• Publication Date: 31-Jan-2018
• ICS: 11.200 - Birth control. Mechanical contraceptives
• Technical Committee: ISO/TC 157 - Non-systemic contraceptives and STI barrier prophylactics
• Drafting Committee: ISO/TC 157/WG 20 - Clinical trials
• Current Stage: 9093 - International Standard confirmed
• Completion Date: 07-Dec-2023

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 11249:2018(E)
©
ISO 2018

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ISO 11249:2018(E)

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ii © ISO 2018 – All rights reserved

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ISO 11249:2018(E)

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 investigat
...