PMCF模板
目录
1. Background.
2. Research issues
3. Objective
4. Post-market follow-up plan
4.1.Study population
4.2.Inclusion/exclusion criteria
4.2.1. Inclusion criteria
4.2.2. Exclusion criteria
4.3. Study design.
4.4. Site and investigator selection.
4.5.Study objective,related study endpoints and statistical considerations4
4.5.1.Studyobjective
4.5.2 Related study endpoin
4.5.3. Indicators of evaluation criteria for related study endpoint
4.5.4. Statistical analysis
4.6. Case number
4.7.Duration of patient follow
4.8. Data collection
4.9. Interim report
4.10. Early study termination procedures or standard
4.11. Ethical considerations
4.12. Data quality control methods
4.12.1 Data transfer
4.12.2. Data entry and verification
4.12.3. Data processing
5.Appendi
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