Good clinical practice gcp is an international ethical and scientific quality standard for designing recording and reporting trials that involve the participation of human subjects compliance with this standard provides public assurance that the rights safety and wellbeing of trial subjects are protected and that clinical trial data are credible. Good clinical practice fda regulates scientific studies that are designed to develop evidence to support the safety and effectiveness of investigational drugs human and animal biological . The documents posted below include the various publications that contributed to the development of final rules related to fdas regulations on good clinical practice and clinical trials part 50 . Good practice of clinical drug trials spriet alain dupin spriet therese coluzzi robert md on amazoncom free shipping on qualifying offers good practice of clinical drug trials
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