Abstract

An unique clinical research supervision and management system has been established for the Peking University Clinical Research Program after 5 years practice of clinical research management, to face the challenge in this new research field in China. We have taken a series approaches including the pre-study, during-study, and post-study to fulfill the requirements of innovative, scientific, feasible, clinical significance and ethical standard of the study. This article is hereby introduced in order to communicate and discuss with fellow researchers. Key words: Peking University Clinical Research Program; Investigator-initiated study; Supervision & management; Quality assurance

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