Автор:Hardik Prajapati,Rajesh K.Patel and Bhuvan P.Raval Год: 2012 Издание:
LAP Lambert Academic Publishing Страниц: 92 ISBN: 9783846589212 Good Clinical Practice (GCP) is an international quality standard that is provided by International Conference on Harmonization (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects. “Good Clinical Practice (GCP) is defined as a’ standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are protected.” “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, safety and well-being of trial subjects are protected; consistent with the principles that have their origin...