Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 82

The ICH E6(R2) presents a set of international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects (ICH E6(R2) Introduction). The Guideline includes principles that lay the foundation for the responsibilities and operational standards of GCP. It is important to understand the application of principles to guide the behavior and chain of reasoning for all who are involved in the conception, planning, and execution of a clinical trial in order to protect human subjects and ensure the integrity of trial data.