Clinical Database Management

临床数据管理

在临床试验过程中，确保数据的真实性、完整性和保密性是至关重要的。我们严格遵循《医疗器械临床试验质量管理规范》（国家食品药品监督管理总局、中华人民共和国国家卫生和计划生育委员会令第25号）来管理数据，以确保临床试验数据的可追溯性和可靠性。

During clinical trials, ensuring data authenticity, integrity, and confidentiality is crucial. We strictly adhere to the "Quality Management Practices for Medical Device Clinical Trials" (Order No. 25 of the China Food and Drug Administration and the National Health and Family Planning Commission of the People's Republic of China) to manage data, ensuring the traceability and reliability of clinical trial data.

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Key Considerations

关注重点

统计分析过程中应关注以下要点：安全性和有效性指标选择的科学性，应有流行病学或临床依据；统计实施的合理性，应结合临床试验流程制定合适的数据收集计划；样本量计算的科学性，计算应有充分的科学依据；数据分析的全面性，需考虑安全性和有效性验证的指标内容，进行合理有效的统计分析。数据集的分配应符合临床试验实际情况，以确保试验的可信度。

Scientific selection of safety and efficacy indicators: These should be based on epidemiological or clinical evidence.
Rational statistical implementation: Develop an appropriate data collection plan that aligns with the clinical trial process.
Scientifically grounded sample size calculation: Ensure the calculation has a solid scientific basis.
Comprehensive data analysis: Consider both safety and efficacy verification indicators. Conduct reasonable and effective statistical analysis. Align dataset allocation with the clinical trial's actual circumstances to ensure credibility.

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