整理ICHGCP中英文对照.pptxVIP

ICH 三方协调指导原则;that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e. the relationship cannot be ruled out. 在一个新的药品或药品的新用途在批准之前的临床实践，尤其是治疗剂量尚未确定前，ADR 是指与 药物任何剂量有关的所有有害的和非意求的反应都应被考虑为药物不良反应。该术语用于药品是指在药 品与不良反应之间的因果关系至少有一个合理的可能性，即不能排除这种关系。 Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting). 对已上市药品，ADR 指人对用于预防、诊断或治疗疾病或改善生理功能的药物在常用剂量出现的有害和 非意求反应（参见 ICH 临床安全性数据管理指导原则：快速报告的定义和标准）。 Adverse Event (AE) 不良事件（AE） Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting). 在用药病人或临床研究对象中发生的任何不幸医疗事件，他不一定要与治疗有因果关系。因此，一 个不良事件（AE）可以是与使用（研究）药物在时间上相关的任何不利的和非意求的征兆（包括异常的 实验室发现）、症状或疾病，而不管其是否与药物有关（参见 ICH 临床安全性数据管理指导原则：快速 报告的定义和标准）。 Amendment (to the protocol) 修改（试验方案） See Protocol Amendment. 见试验方案修改 Applicable Regulatory Requirement(s) 适用的管理要求 Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products. 有关实施试验用药品临床试验的任何法律和法规。 Approval (in relation to Institutional Review Boards) 批准（机构审评委员会） The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution,