The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the …

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 …

The E6(R3) Guideline builds on key concepts outlined in ICH E8(R1) General Considerations for Clinical Studies. This includes fostering a quality culture and proactively designing quality into …

ICH E6 (R3) introduces innovative provisions designed to apply across various types and settings of clinical trials, ensuring continued relevance in the face of ongoing technological and …

2021年4月19日 · Acknowledging the wide and substantial impact of ICH E6, the ICH Management Committee is making available a draft, work-in-progress version of the updated principles that …

ICH GCP指导原则的目的是为欧盟、日本和美国提供统一的标准,以促进这些管理当局在其权限内相互接受临床数据。 本指导原则的发展考虑了欧盟、日本、美国,以及澳大利亚、加拿大、北欧 …

INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE ICH E6(R2) INTRODUCTION Good Clinical Practice (GCP) is an international ethical and scientific …

2024年12月11日 · ICH E8 (R1): General Considerations for Clinical Studies This guidance describes internationally accepted principles and practices in the design and conduct of clinical …

2023年11月9日 · The objective of this ICH GCP guidance is to provide a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical …

2025年2月20日 · Integrated addendum to ICH E6 (R1): guideline for good clinical practice E6 (R2) [PDF, 693.2 KB] Overseas effective date: 9 November 2016. Replaces: Note for guidance on …