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ICH E6(R3) Guideline 1 1 I. INTRODUCTION 2 Good Clinical Practice (GCP) is an international, ethical, scientific and quality standard for the 3 conduct of trials that involve human participants. Clinical trials conducted in accordance with 4 this standard will help to assure that the rights, safety and well-being of trial participants are
The Draft Principles of ICH E6 Good Clinical Practice (GCP) now available. The ICH E6 Good Clinical Practice (GCP) Guideline is widely used by clinical trial researchers beyond the membership and regional representation of ICH itself and has a significant impact on trial participants and patients.
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 data by the...
This guideline should be read in conjunction with other ICH guidelines relevant to the conduct of clinical trials (e.g., E2A (clinical safety data management), E3 (clinical study reporting), E7 (geriatric populations), E8 (general considerations for clinical trials), E9 (statistical principles), and E11 (pediatric populations)).
This document addresses the good clinical practice, an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.
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 data by the...
ICH E6 Good Clinical Practice (GCP) Guideline is widely used by clinical trial researchers beyond the membership and regional representation of ICH itself and has a significant impact on trial participants and patients.