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 observe the effect of different fixation methods on cervical curvature and axial symptoms in posterior cervical single?door surgery??Methods From September 2014 to February 2016, 112 patients with multi?segment cervical spondylotic myelopathy underwent surgical treatment in Handan Central Hospital of Hebei Province??According to the lamina fixation methods,they were divided into groups A,B and C??There were 35 cases in group A,using suture suspension method to fix lamina; 34 cases in group B,using anchor suspension to fix lamina;and 43 cases in group C,using mini?titanium plate to fix lamina The operation time,intraoperative blood loss,laminae open angle,spinal drift distance,postoperative neurological recovery,cervical curvature index ( CCI ) and occurrence of axonal symptoms were compared in each group??Results All patients underwent surgery successfully??There were no significant differences in operation time,intraoperative blood loss,laminae open angle and spinal drift distance between the 3 groups (all P＞0??05)??The JOA score of group A was (7??9± 2??2) preoperatively,(9??3± 2??8) at 3 months after surgery,and (13??9±3??4) at the final follow?up??In Group B was (7??7±2??0) preoperatively,(9??1±2??7) at 3 months after surgery,and (13??6±3??7) at the final follow?up??In Group C was (7??8±2??1),( 9??0±2??6) and (13??8 ± 3??5 ), respectively, there were significant differences before and after operation ( Fintra?grouP＝7??271, Pintra?grouP ＜ 0??001; Finter?grouP ＝ 11??372, Pinter?grouP ＜ 0??001; Finteraction ＝ 9??831, Pinteraction＜0??001)??The CCI of group A was ( 22??7± 5??6)% preoperatively,(20??5± 4??4)% at 3 months after surgery,and (16??6± 3??0)% at the final follow?up??The CCI of group B was ( 21??4 ± 5??2)%,( 19??7 ±4??1)% and (17??8±2??9)% respectively??The CCI of group C was ( 21??1 ± 5??0)%,( 20??8 ± 4??6)% and (19??8 ± 4??0)% respectively??There were significant differences between group A and group B in the last follow?up and the three months before and after operation??( all P＜0??05),there was no significant difference between groups C at different time points ( P＞0??05)??According to the visual analogue scoring system,the distribution of axial symptoms in group C was significantly better than that in group A and group B ( Z＝6??678;P＝0??035)??Conclusion Posterior single?door mini?titanium plate fixation can not only improve nerve function,but also prevent cervical curvature loss and reduce the occurrence of axonal symptoms??

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.