The International Conference on Harmonization Good Clinical Practice guideline.
The International Conference on Harmonization Good Clinical Practice guideline.
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DOI：
10.1080/105294199277860
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发表时间：
1999-02
期刊：
影响因子：
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通讯作者：
James R. Dixon
中科院分区：
文献类型：
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作者：
James R. Dixon
国际协调会议（ICH）良好临床规范（GCP）指南的目的是保护参与临床试验的人类受试者的权利，并确保在人类临床研究中收集的数据的科学有效性和可信度。该指南的指导原则是，受试者的权利、安全和福祉是最重要的考虑因素，应优先于科学和社会的利益。该指南将对三个参与地区（美国、欧洲和日本）以及世界上许多其他地区的临床试验产生重要和有益的影响。在未来的几年里，它应该实现其预期目标，即更经济地利用人力、动物和物质资源，消除全球新药开发和供应方面的不必要延误，同时保持质量、安全和疗效保障以及保护公众健康的监管义务。
The purposes of the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guideline are to protect the rights of human subjects participating in clinical trials and to ensure the scientific validity and credibility of the data collected in human clinical studies. The guiding principle in the guideline is that the rights, safety, and well-being of the trial subject are the most important considerations and should prevail over the interests of science and society. The guideline will have an important and beneficial impact on the clinical trials conducted in the three participating regions (the United States, Europe, and Japan) as well as many other regions throughout the world. In the years to come, it should fulfill its intended purpose of providing for a more economical use of human, animal, and material resources and the elimination of unnecessary delays in the global development and availability of new medicines, and at the same time maintaining safeguards on quality, safety, and efficacy and regulatory obligations to protect public health.