Copper-bearing intrauterine contraceptive devices - Guidance on the design, execution, analysis and interpretation of clinical studies
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 ISOÂ 14155.
| SDO | ISO: International Organization for Standardization |
| Document Number | ISO 11249 |
| Publication Date | May 1, 2026 |
| Language | en - English |
| Page Count | 30 |
| Revision Level | |
| Supercedes | |
| Committee | ISO/TC 157 |
Failed to load document history.
| Publish Date | Document Id | Type | View |
|---|