ISO INTERNATIONAL STANDARD 29943-2 First edition 2017-07 Condoms Guidance on clinical studies - Part 2: Female condoms, clinical function studies based on self-reports Preservatifs - Lignes directrices relatives aux études cliniques - Partie 2: Preservatifs feminins, analyse fonctionnelle des défaillances graves sur la base d'auto-déclarations Reference number ISO 29943-2:2017(E) so International Organization for Standardization @ IS0 2017 ed without license from IHS IS0 29943-2:2017(E) COPYRIGHTPROTECTEDDOCUMENT IS0 2017, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISO's member body in the country of the requester. ISO copyrightoffice Ch. de Blandonnet 8 . CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 [email protected] www.iso.org PrganizationforStandardization @ IS0 2017 - All rights reserved etworking permitted without license from IHS IS0 29943-2:2017(E) Contents Page Foreword ..V Introduction. ...vi 1 Scope 2 Normative references 3 Terms and definitions 4 Risk assessment. ..3 5 Pilot clinical studies ..3 6 Clinical validation investigation 6.1 Objectives of clinical validation investigation ..4 6.2 Outcome measures. ..4 6.3 Study subjects. .4 6.3.1 General. 6.3.2 Enrolment of study subjects .5 6.4 Informed consent. 6.5 Test and control condoms 6 6.5.1 General. ..6 6.5.2 Test condom .7 6.5.3 Control condom .7 6.5.4 Trial duration exceeds one year 1 6.5.5 Sampling of control condoms for bench testing .8 6.6 Randomization .8 6.7 Allocation concealment and study masking ..8 6.8 Use of additional lubricant. 6.9 Instructions and interactions with study couples. ..8 6.10 Interviews and data collection. 6.10.1 Schedule for interviews and condom distribution .9 6.10.2 Enrolment interview.. .9 6.10.3 Individual condom use CRF ..10 6.10.4 Mid-study CRE, crossover trial .10 6.10.5 Compiling data from CRFs .11 6.11 Data integrity .11 6.11.1 General. ..11 6.11.2 Interactive voice response systems (IVRS) .11 6.11.3 Mail-in and web-based data reporting ..1 6.11.4 Web-based data collection systems, additional suggestions ..12 6.12 Controlofdistributionchain .13 6.13 Analysisofreturnedcondoms .13 6.14 Other methodological details. ..13 6.15 Statistical analysis plan. .14 6.15.1 General. .14 6.15.2 Primary study hypothesis .14 6.15.3 Secondary study hypotheses .15 6.15.4 Studydesign ..15 6.15.5 Statistical analysis. ..15 6.15.6 Additionalstatisticalcommentsandconcerns .16 6.16 Clinical study results: Review and interpretation. ..16 6.16.1 General. .16 6.16.2 Total clinical failure rates for control condom ..16 6.16.3 Non-inferiority ..16 6.16.4 Superiority ..17 6.16.5 Safety (adverse events) ..17 6.16.6 What happens if one is unable to conclude non-inferiority?. iii ted without license from IHS