临床研究

良好的临床实践

良好的临床实践

描述: 
The tripartite harmonised ICH Guideline was finalised under 步 4 在五月 1996. 该临床试验规范文档描述了在临床试验中的行为的责任和所有参与者的期望, 包括调查, 显示器, 赞助商和机构审查委员会. 监测控制点覆盖方面, reporting and archiving of clinical trials and incorporating addenda on the Essential Documents and on the Investigator's Brochure which had been agreed earlier through the ICH process.
履行: 
步 5
美国:
通过采用CPMP, 七月 1996, 已作为CPMP / ICH / 135/95 /步骤5, 注释和评论上述, 印发CPMP /97分之768
日本厚生劳动省:
采用三月 1997, PAB通知无. 430, 日本厚生劳动省条例没有. 28
FDA:
发表在联邦纪事, 9 可能 1997, 卷. 62, 没有. 90, p. 25691-25709
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审计GCP

审计, GCP

审计, GCP Responsibilities The GCP Auditor is responsible for quality assurance auditing of all activities subject to the, “ICH良好的临床实践: 统一的指导原则,” (地面控制点), 配套的质量保证方案 (QA) to ensure that 阅读更多…

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审计GCP

高级临床研究员

Responsibilities Assisting in the design and execution of high quality clinical studies in compliance with FDA and ICH requirements. 功能作为主要联络人,以临床研究者/现场工作人员. 鉴定, 修饰, 发起, monitor and close out 阅读更多…

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临床研究

干细胞 – 2018

干细胞 – 2018 十月 21-22, 2018 medical conference Title: Stem cell-2018 Location: 基辅,Ukraine Venue:   音箱: Dr Eugene Zadorin Dr Andrew Gilbert ( 加拿大) 主题: 细胞疗法 & Regenerative Medicine Cancer stem cells as 阅读更多…

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临床研究

CRA认证

A Clinical Research Associate (CRA) is a profession defined by Good clinical practice guidelines (ICH GCP). The main function of a clinical research associate is to monitor clinical trials. He or she may work directly with the sponsor 阅读更多…

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干细胞治疗