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. Good clinical practice 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. Fda regulations relating to good clinical practice and clinical trials here are links to fda regulations governing human subject protection and the conduct of clinical trials electronic records. Good clinical practice gcp is an international quality standard for conducting clinical trials that in some countries is provided by ich an international body that defines a set of standards which governments can then transpose into regulations for clinical trials involving human subjects. Since the state food and drug administration sfda in china regulated the clinical trial industry with an amendment of the chinese good clinical practice gcp guidance both the quality and integrity of clinical research have improved significantly resulting in the recognition of more and more chinese trial results by the international pharmaceutical community this paper outlines the major regulatory practices related to conducting clinical trials in china
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