Drug Clinical Test Quality Management Specification

2018-12-24

Chapter 1 General Principles 1 to ensure the clinical trial process specification，Science and reliable results，Protect the rights and interests of the subject and protect its safety，According to the "Pharmaceutical Management Law of the People's Republic of China"、"Implementation Regulations of the People's Republic of China Drug Administration Law"，Refer to the internationally recognized principles，Develop this specification。The quality management specifications of clinical trials of drugs are the standards of the entire process of clinical trials，Including solution design、stake betting appOrganization My stake betting appImplementation、Monitoring、Inspection、Record、Analysis summary and report。Article 3 All the clinical trials of each phase、Human biological utilization or biological equivalent test，All must be implemented in accordance with this specification。Article 4 All people are right ...