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.

Certain clinical trial concerns are not addressed in this document, including participant compensation, confidentiality of participants 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.