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BS ISO 11249:2018 Copper-bearing intrauterine contraceptive devices. Guidance on the design, execution, analysis and interpretation of clinical studies >
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BS ISO 11249:2018 Copper-bearing intrauterine contraceptive devices. Guidance on the design, execution, analysis and interpretation of clinical studies, 2018
- National foreword
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Planning an IUD trial — Good clinical practice
- 5 Ethics [Go to Page]
- 6 Identification and description of the investigational device
- 7 Preliminary investigations and justification for the design of the clinical investigation [Go to Page]
- 8 Objectives and hypotheses of the clinical investigation
- 9 Design of the clinical investigation [Go to Page]
- 10 Adverse events, adverse device effects and non-medical complaints
- 11 Early termination or suspension of the clinical investigation
- 12 Publication policy
- Annex A (informative) Exclusion and inclusion criteria for IUD trials
- Annex B (informative) Timing of insertion of IUD: When can an IUD be inserted?
- Bibliography [Go to Page]
