GCP guidelines list the essential documents (ICH GCP E6 Section 8) that, at a minimum, must be maintained for every clinical study. These documents are to be maintained by the site and the sponsor, and are classified according to the stage of a study at which they are normally created. T...
The sponsor should describe the quality management approach implemented in the trial and summarize important deviations from the predefined quality tolerance limits and remedial actions taken in the clinical study report (ICH E3, Section 9.6 Data Quality Assurance). 申办者应该在临床试验报告中描述试验中...
Documents that individually and collectively permit evaluation of the conduct of a study and the quality of the data produced (see section 8. "Essential Documents for the Conduct of a Clinical Trial"). 1.24 临床试验管理规范(GCP)【Good Clinical Practice (GCP)】 术语表—ICH E6 中英对照版 -无名...
《ICH-GCP》临床试验管理规范E6(R2)中英双语版语料 2023 05/30 CODEX科译 企业 + 分享 CODEX科译 A- A+ 临床试验必需文件应当可以基于试验特定文件的重要性和关联性进行适当增补或缩减(在试验启动前进行调整)。 INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE ICH E6(R2) 临床...
GCP指南列出了每个临床研究至少必须保留的基本文件(ICH GCP E6第8节)。这些文件将由站点和赞助商维护,并根据通常创建这些文件的研究阶段进行分类。这些文档可以在多个位置维护,这取决于它们是与法规文件一起存储,还是作为参与者文档存储。申办人和研究人员/机构应保存各自重要文件(包括源文件)存放位置的记录。其他文件可...
E6 ICH GCP指导原则 INTRODUCTION 前言 Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights,...
E6: Good Clinical Practice: Consolidated Guideline GCP:良好的临床规范:统一的指南 E7: Studies in Support of Special Populations: Geriatrics 对特定族群的支持的研究:老人病学 E8: General Considerations for Clinical Trials 对临床试验的总的考虑 E9: Statistical Principles for Clinical Trials 临床试验的统计...
20、所需量-效关系的资料E5(R1) Ethnic Factors in the Acceptability of Foreign Clinical Data 对国外临床研究资料的种族因素的可接受性E6(R1) Good Clinical Practice: Consolidated Guideline 药品临床研究规范(GCP) 一致性指导原则E7 Studies in Support of Special Populations: Geriatrics 老年人群的临床研究E8 ...
8 Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice 2. THE PRINCIPLES OF ICH GCP 2.1 Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable ...
Documents that individually and collectively permit evaluation of the conduct of a study and the quality of the data produced (see section 8. "Essential Documents for the Conduct of a Clinical Trial"). 1.24 临床试验管理规范(GCP)【Good Clinical Practice (GCP)】 术语表—ICH E6 中英对照版 -无名...