Aims: To improve the countermeasures of clinical trial institutions against major public health events such as COVID-19. Methods: A questionnaire was created to investigate the effects of the global static management policy against COVID-19 on clinical trials in Shanghai in 2022. And the convenience sampling combined with snowball sampling were adopted to interview clinical research coordinators (CRC) and clinical research associates(CRA) on the platform of SOJUMP as well as WeChat. Results: 156 valid questionnaires were collected, with an effective recovery rate of 93.98%. 98.07% of the respondents believed that the effects was severe. The extent of effects on different links of clinical trials was different (rank sum test P<0.01), being great on medication/follow-up (76.28% of significant effects), monitoring/audit (74.36%) and screening/admission (71.79%).The protocol deviations associated with out of visit window (experienced by 94.23% of respondents, during the static management policy), inspection (78.85%), medication (67.95%) and withdrawal (62.82%). And the interviewees reported 49.66% of the exclusion should blame the epidemic situation. The development of online-office or remote-ethics meetings alleviated the impact of lockdown policy on approval/ethics/contract and data cleaning/site closing. 90.98% of oral drugs could be sent by express delivery, but only 1.28% had the experience of online informed consent and remote inspection. Conclusions: We shall speed up the application of the intelligent clinical trial system and remote monitoring system, realize the transformation to a new model of patient-centered clinical trial, and improve the ability to cope with major public health events such as COVID-19.

Background Aiming at the poor quality of small lectures due to the lack of lecturing skills of the clinical teachers in residency standardized training, the Teaching and Training Department of Shanghai East Hospital set up a continuous improvement project of lecturing skills for the clinical teachers to search for effective ways to improve lecture quality, then the effect was evaluated. Methods Based on the ADDIE model of training design, the department conducted the project in accordance with a process of analysis, design, development, implementation and evaluation. A special course “Clinical Teacher Presentation Training” (CTPT) was developed to convey and train the 5 key behaviors in presentation to improving lecture quality of the clinical teachers. Ninety-nine clinical teachers who give lectures to the residents were recruited as subjects for the project. Adopted the model of “intensive training + practice transference” to strengthen lecturing skills, and applied the Kirkpatrick Four Levels to evaluate the effect of the project from multi-role and multi-stage. Results The training satisfaction of the CTPT course from the subjects reaches 100%. The subjects have a high degree of knowledge acquisition through CTPT and the knowledge of the 5 key behaviors has been actually used in their lectures at the stage of practice transference. Comparing the data before training and after transference, it is found that the average increasing of the subjects’ 5 key behavior scores made by teaching secretaries is 14.12 points (14.12%) and that of the subjects’ self-efficacy scores is 9.31 points (9.31%); the performance values were modeling based on the scores from different types of evaluators and increased by an average of 12.61 points (12.61%); and the star ratings of the overall performance increased by an average of 1.17 points (23.4%). The results showed statistically difference (P < 0.001). Conclusions The project effectively promoted the improvement of the clinical teachers’ lecturing skills and the quality of small lectures.