合格的研究者是保证临床试验质量的关键。
Qualified investigators play a key role in guaranteeing the quality of clinical trials.
药物临床研究必须经国家药品监督管理局批准后实施，必须执行《药物临床试验质量管理规范》。
Clinical study of drugs must be approved by the SDA before it is carried out, and must follow the Criterions for the Quality Control of Clinical Trial of drugs.
方法：结合笔者多年的临床研究工作管理经验，对药物临床试验质量的关键环节和控制措施进行探讨并提出建议。
METHODS:According to the experience of author on clinical research management in many years, key step and control measure of drug clinical trials were explored to put forward recommendations.
临床试验数据的采集、报告与处理的每一步骤都可能伴随错误，临床试验数据质量的评估是临床试验质量控制的重要措施。
Each step about data which are collected, reported and manipulated has an error rate associated with it. Therefore, measuring data quality is a key element of quality control for clinical trial data.
在医学/科学事务，临床研究运营，药物警戒和数据管理等多项职能工作中，主动提供医学专业领导力和科学指导，提高临床试验质量。
Proactively provide the medical leadership and scientific input to improve the project quality in the function of medical science, phamacovigilance, clinical operation and data management etc.
为了满足对儿童药物的研究需要，加强儿科临床试验研究的质量和数量至关重要。
In order to address the research needs for children's medicines, strengthening the quality and quantity of paediatric clinical trials research is essential.
正在进行的和计划中的临床试验将会继续寻求预防治疗相关的副反应和改善前列腺癌患者生活质量的对策。
Ongoing and planned clinical trials will continue to address strategies to prevent treatment-related side effects and improve quality of life for men with prostate cancer.
研究人员有选择的分析了随机对照临床试验(临床研究的金标准)，以确保只采用最高质量的数据。
The researchers limited their analysis to randomized controlled trials, which are the gold standard of clinical research, to ensure that only the highest quality data were used.
这个网站相当于一个进入全球大量高质量临床试验记录的入口。
The site works as an entry point or portal into multiple, high quality clinical trial registers with a global search function.
所评价文献的低质量说明手法治疗肩周炎的临床试验存在一些应引起注意的方法学问题。
The low quality of evaluated articles suggests that there exist some methodology problems in the clinic test on treating periarthritis of shoulder with manipulation.
此外，该临床试验也将评估与甲状腺彻底清除相关的生活质量参数。
In addition, the clinical trial also will evaluate the quality-of-life parameters associated with complete removal of the thyroid gland.
目的：保证药物临床试验的质量和保障受试者的权益。
OBJECTIVE: to guarantee the quality of the clinical drug trial and to ensure the interests of the subjects.
目的评价中医药治疗癌痛临床试验文献的质量。
Object Appraising the quality of clinical trials literature about the Chinese medicine treating the cancer pain.
结论中医药治疗癌痛临床试验文献质量还不够高，需要进一步改进和提高。
Conclusion the quality of clinical trials literatures about the Chinese medicine treating the cancer pain is still not high enough, and needing further enhancement and improvement.
目的：依据循证医学观点，分析药物临床试验的质量。
Aim: to analyse the quality of clinical pharmaceutical trials according to the viewpoint of evidence-based medicine.
目的总结多中心临床试验“血脂康调整血脂对冠心病的二级预防研究”中血清总胆固醇（TC）和甘油三酯（TG）测定室间质量控制结果。
Objective To summarize the external quality control results on the measurement of TC and TG for a multi-center clinical trial.
标准化的统计分析不仅是正确评价药物安全性和有效性的基础和依据，更是规范化高质量临床试验的重要标志。
Standardized statistical analysis is not only the foundation for evaluation of security and validity of drug, but also the important sign of standardized high-quality clinical trial.
方法按照循证医学（EBM）的标准，对《中华烧伤杂志》2000-2004年刊登的临床试验论文进行回顾性检索及综合分析，以评价其质量。
Methods All the papers of clinical study published in Chinese Journal of Burns (CJB) from 2000 to 2004 were evaluated according to EBM standard.
目的：研究临床试验知情同意书中要素的完整性，评价撰写质量。
Objective:To assess the integrity and quality of informed consents from clinical trials and researches.
方法结合管理实践，应用医疗设备质量管理体系方法，分析体外诊断试剂临床试验管理的重点，并提出解决办法。
Methods Applied medical instruments 'quality management system, analyzed the emphasis of in vitro diagnostic reagents management, and gave the solution to it.
高质量的随机对照临床试验均未检测以患者为中心的结局指标，如健康相关生命质量、糖尿病并发症及死亡率等。
Many patient-oriented outcomes like health-related quality of life or diabetes complications and mortality were never investigated in high-quality randomised clinical trials.
来自爱沙尼亚的一项绝经期妇女激素治疗临床试验显示：激素治疗并不能提高妇女的生活质量。
A postmenopausal hormone therapy trial conducted in Estonia indicates that hormone therapy does not improve women's quality of life.
目的：加强多中心临床试验管理，提高试验效率，缩短试验周期，减少药物浪费，保障试验质量。
AIM: To enhance management and efficiency of clinical trials, reduce the clinical trial cycle, waste drug, and insure the quality of trials.
因纳入文献和样本量有限，建议进行大样本、长期随访的高质量临床试验，提供更佳循证证据。
Because of few studies and small samples, more high quality trials with large samples and longer following-up are proposed.
中国循证医学的研究领域包括循证医学教育、系统评价、随机对照临床试验文献质量评价等。
The study fields of EBM in China include EBM education, systematic review, and critical evaluation of randomized controlled trial (RCT), etc.
中国循证医学的研究领域包括循证医学教育、系统评价、随机对照临床试验文献质量评价等。
The study fields of EBM in China include EBM education, systematic review, and critical evaluation of randomized controlled trial (RCT), etc.
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