Effective supervision of the clinical research management department can guarantee and improve the quality of the investigator initiated trials(IIT). The authors analyzed relevant clinical research regulations and literature and summarized the current situation of risk-based IIT project process quality management. On such basis, they determined the risk-based IIT project process quality management method in combination with the previous research of the research group.From 2021 to 2022, this method was used to implement process quality management for 353 IIT projects in Shanghai′s tertiary hospitals. More than 3 000 risk points were identified through centralized supervision, and then on-site supervision was carried out to correct the problems found. As proven by the results, the method could find existing problems in time and define the risk level of the project, and also formulate an individualized risk supervision plan accordingly, so as to effectively ensure the data reliability and scientific results. It is suggested that the clinical research management department implement risk based management for the whole process of IIT projects, increase funding and staffing, and implement hierarchical management for the projects by research types, so as to promote the sustainable development of IITs.

Objective:To assess possible risk factors and their respective levels in the whole process of investigator initiated trial(IIT)projects proposed in the proposal stage, for reference in formulation of risk management plans.Methods:Through literature analysis and research group discussions, the risk factors of IIT projects and risk level assessment criteria were preliminarily identified, and a consultation questionnaire was developed as a result. Delphi method was used to further optimize the risk factors and determine their risk levels. Data obtained from the consulfation were analysied by descriptive.Results:The recovery rates of two rounds of expert consultation were both 100%, and the degree of expert authority was 0.942. The survey finalized 38 risk factors, including extremely high risk, high risk, medium risk, low risk and very low risk factors of 17(44.7%), 15(39.5%), 3(7.9%), 2(5.3%) and 1(2.6%) respectively.Conclusions:This study determined a risk evaluation system of IIT projects in the proposal stage. This system can identify risks of IIT projects at an early stage, facilitating early intervention of problems existing in such projects, and minimize risks to the rights and safety of patients.

Objective:To constructe an evaluation index system for clinical research innovation in medical institutions, for references for enhancing the research and innovation capabilities of medical institutions and formulating policies related to clinical research innovation.Methods:From March 2022 to May 2023, relevant literature and policies on the evaluation system of scientific and technological innovation at home and abroad were analyzed to establish the preliminary screening clinical research innovation indicators. Two rounds of Delphi method were used to construct a clinical research innovation index evaluation system, analytic hierarchy process was used to calculate the weights of each indicator.Results:The effective response rates of the two rounds of consultation questionnaires were both 100.00%, with expert authority coefficients of 0.95 and Kendall coordination coefficients of 0.85 and 0.87, respectively. The clinical research innovation index evaluation system ultimately established 4 primary indicators, 13 secondary indicators, and 42 tertiary indicators. The first level indicators included infrastructure construction, innovation support environment, clinical research activity, and innovation effectiveness, with weight coefficients of 18.00%, 21.00%, 30.00%, and 31.00%, respectively.Conclusions:The clinical research innovation evaluation index system constructed in this study covered the investment, environment, and output aspects of research innovation, and could comprehensively and objectively reflect the clinical research innovation ability of medical institutions.