The quality control of medical devices clinical trials finished by drug clinical research institute office / 中国医学装备

ABSTRACT

Objective:To ensure the authenticity, scientific and reliability of medical devices clinical trials results.Methods: The drug clinical research institute office set up full-time secondary quality control team, clarified the responsibility, made application form, problem check and track list, subjects’ identity registration form. Using computer network to make 19 medical equipment quality control of clinical trials.Results: Assure the rights and safety of subjects, the validity, accuracy and completeness of clinical trial data and clinical trial results.Conclusion: The drug clinical research institute office, full-time secondary quality control team made strict clinical trial project for the whole process of quality control and ensure the true, scientific and reliable results.