摘要目的 国家重点研发计划医学类项目管理难度大,本文拟分析项目启动常见问题和汇总项目启动前的准备工作.方法 综合运用文献分析、调查研究等方法,指出医学类项目启动常见的问题,并从研究者视角重点介绍医学类项目尤其是临床研究保障项目启动顺利实施的具体措施.结果 提出了提高项目启动质量的常见措施,具体包括:理清组织管理框架、发挥启动会应有作用、重视财务培训、研究方案及相关文件准备、申报伦理及方案注册、规范文档管理、制定项目管理计划、及时物资筹备.结论 国家重点研发计划医学类项目启动前需做好计划,结合研究特点,从人、财、物、进度、质量、数据等方面充分筹备.

abstractsObjective 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.