Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 80

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, safety and well‐being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. (ICH E6(R2) Introduction).