Quality evaluation of Investigator-Initiated Trials at the early approval stage

Objective With the fast development of Investigator-Initiated Trials (IIT), more and more resources from the national and local governments, universities and hospitals were invested. It is important to clarify the content and methodologies of quality evaluation of the IITs at the early approval stage to assure more complete and systematic quality assessment, improve resource allocation, enhance the research ability, as well as the protection of human subject. Methods This article summarized the content and related safeguarding measures of quality assessment during the early stage of project setup. Discussed relative practice and experiences of our center. Results The contents of quality evaluation include research topic, study protocol, research team and qualifications, quality assurance plan and risk management. The organizing work and attention of the research administrative department, qualified departments and experts, as well as information platform are the required safeguarding measures for effective assessment. Conclusions Quality evaluation of IITs at the early approval stage is critical segment of study quality assurance. More attention should be paid to make every effort counts. Key words: Investigator-Initiated Trials; Quality evaluation; Risk management