ISO INTERNATIONAL STANDARD 29943-1 First edition 2017-07 Condoms Guidance on clinical studies - Part 1: Male condoms, clinical function studies based on self-reports Préservatifs - Directives relatives aux études cliniques - Partie 1: Preservatifs masculins -Etudes fonctionnelles cliniques basées sur des auto-déclarations Reference number ISO 29943-1:2017(E) so International Organization for Standardization @ IS0 2017 IS029943-1:2017(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 written permission. Permission can be requested from either ISO at the address below or ISO's member body in the country of the requester. IsOcopyrightoffice Ch. de Blandonnet 8 . CP 401 CH-1214 Vernier, Geneva, Switzerland Tel.+41 22 749 0111 Fax +41 22 749 09 47 [email protected] www.iso.org Internatinair PrganizationforStandardization @ IS0 2017 - All rights reserved networking permitted without license from IHS IS0 29943-1:2017(E) Contents Page Foreword ..V Introduction. ...vi 1 Scope 2 Normative references 3 Terms and definitions 4 Pilot clinical studies ..2 5 Clinical validation investigation .3 5.1 Objectives of clinical validation investigation 3 5.2 Outcome measures. .3 5.3 Study subjects .3 5.3.1 General .3 5.3.2 Enrolment of study subjects .3 5.4 Informedconsent. .5 5.5 Test and control condoms 5 5.5.1 General. .5 5.5.2 Test condom .5 5.5.3 Control condom made from natural rubber latex .6 5.5.4 Expiration date of control condom .6 5.5.5 Storage conditions. .6 5.5.6 Trial duration exceeds 1 year. 5.5.7 Sampling of control condoms for bench testing .6 5.6 Randomization. 5.7 Allocation concealment and study masking 7 5.8 Use of additional lubricant... 1 5.9 Instructions and interactions with study couples .7 5.10 Interviews and data collection. .8 5.10.1 Schedule for interviews and condom distribution. 5.10.2 Enrolment interview .8 5.10.3 Individual condom use CRF ..8 5.10.4 Mid-study CRE, crossover trial 9 5.10.5 Compiling data from CRFs. 5.11 Data integrity .10 5.11.1 General 10 5.11.2 Interactive voice response systems (IVRS) ..10 5.11.3 Mail-in and web-based data reporting ..10 5.11.4 Web-based data collection systems and additional suggestions ..11 5.12 Control of distribution chain. .11 5.13 Analysis of returned condoms. .12 5.14 Other methodological details. .12 5.15 Statistical analysis plan. ..12 5.15.1 General. ..12 5.15.2 Primary study hypothesis ..13 5.15.3 Secondary study hypotheses ..13 5.15.4 Study design. .13 5.15.5 Statistical analysis. ..14 5.15.6 Additional statistical comments and concerns ..14 5.16 Clinical study results: Review and interpretation .15 5.16.1 General. .15 5.16.2 Total clinical failure rates for control condom ..15 5.16.3 Non-inferiority .15 5.16.4 Superiority ..15 5.16.5 Safety (adverse events) .15 iii ed without license from IHS