第一章总则第一条为保证药品临床试验的过程规范可信，结果科学可靠，保护受试者的权益并保障其安全，根据《中华人民共和国药品管理法》，参照国际公认原则，特制定本规范。第二条药品临床试验管理规范是有关临床试验的全过程包括方案设计、组织、实施、监视、审核、记录... Chapter I General Provisions Article 1 In order to ensure that the process of drug clinical trials is credible, the results are scientific and reliable, the rights and interests of the subjects are protected and their safety guaranteed, according to the “Law of the People’s Republic of China on Drug Administration” and with reference to internationally accepted principles, This specification. The second drug clinical trial management code is the entire process of clinical trials including program design, organization, implementation, monitoring, auditing, recording ...