Project approval review is the key link to improve the quality of medical device clinical trials.Through a comprehensive analysis of typical problems found in the project initialization stage in the form of cases,it is suggested that the state drug regulatory authorities should further improve the regulations,that the applicants should assume the responsibility of clinical trial quality management,that the clinical trial institutions should establish a sound mechanism for project approval review,and that the researchers should enhance their normative awareness,so as to ensure the qual-ity of the trial and the interests of the subjects.
Medical DevicesClinical TrialsProject Approval ReviewLink Quality
NETL
NSTL
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