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International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) adopts Consolidated Guideline on Good Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for Human Use.

出版信息

Int Dig Health Legis. 1997;48(2):231-4.

PMID:11656783
Abstract
摘要

相似文献

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International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) adopts Consolidated Guideline on Good Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for Human Use.人用药品注册技术要求国际协调会议（ICH）采用了《人用药品临床试验实施的药物临床试验质量管理规范合并指南》。
Int Dig Health Legis. 1997;48(2):231-4.
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Proposal for a good clinical practice directive.关于良好临床实践指南的提案。
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The changing clinical trials scene: the role of the IRB.不断变化的临床试验场景：机构审查委员会的作用。
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Toward a more comprehensive approach to protecting human subjects: the interface of data safety monitoring boards and institutional review boards in randomized clinical trials.迈向更全面的人类受试者保护方法：随机临床试验中数据安全监测委员会与机构审查委员会的界面
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Clinical trials committees: how long is the protocol review and approval process in Spain? A prospective study.临床试验委员会：西班牙的方案审查与批准流程需要多长时间？一项前瞻性研究。
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Regulatory orphans: juvenile prisoners as transvulnerable research subjects.监管孤儿：作为跨脆弱研究对象的青少年囚犯
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National commission proposes numerous new regulations of institutional review boards.国家委员会提议对机构审查委员会制定众多新规定。
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Health Sciences Council of Japan adopts guidelines for gene therapy clinical research.日本健康科学委员会通过了基因治疗临床研究指南。
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