Table of Contents

Foreword<br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 Pilot clinical studies<br>5 Clinical validation investigation<br>Annex A (informative) - Formula for power calculation<br>Annex B (informative) - Pilot clinical investigation<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(sample outline)<br>Annex C (informative) - Time and events schedule for<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;individual study subject (sample)<br>Annex D (informative) - CRF - Study entry (sample)<br>Annex E (informative) - CRF - Mid-study (sample)<br>Annex F (informative) - CRF - Individual condom use<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(sample)<br>Annex G (informative) - CRF - Adverse event (sample)<br>Annex H (informative) - Protocol for evaluation of returned<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;used condoms<br>Bibliography

Abstract

Defines the design, execution, analysis and interpretation of clinical function studies conducted in accordance with the requirements of ISO 23409 for male synthetic condoms.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	British Standards Institution
Pages
ISBN
Committee	CH/157
Supersedes	14/30296392 DC : 0