How to well prepare before the start of medical projects of The National Key Research and Development Program of China

Objective The management of medical projects of the National Key Research and Development Program of China is difficult. Thus this article aims to analyze the common problems and summarize the preparatory work before the project initiation. Methods Comprehensively adopted the methodologies of literature analysis, survey investigation to analyze the common problems before the project initiation, and then particularly summarize the preparatory works for biomedical research, especially for clinical research, from the perspective of investigators. Results Proposed several aspects that should take into consideration before the initiation of the projects: clarify the organizational management framework, play the role of kick-off meeting, organize tailored training on financial management, prepare research protocol and related documents, seek Institutional Review Board approval and conduct clinical research registration, normalize document managment, formulate project management plan, and prepare research facilities timely. Conclusions Investigators should develop a detailed project management plan before initiation of the project, preparation work should focus on personnel, financial resources, facilities, research progress, quality, data, etc. Key words: The National Key Research and Development Program of China; Clinical research; Initiation; Project management plan