Abstract: Objective To explore the important and difficult points in management of ward and subject in phase I clinical trials while adhering to regular epidemic prevention and control. Methods While adhering to regular epidemic prevention and control in our hospital, we implemented the management for the wards and subjects in phase I clinical trials to ensure the safety of subjects and medical staff. Epidemic prevention strategies included continuous learning about the prevention and therapy of COVID-19; grid management of the wards; establishment of a three-person epidemic prevention team; real-time adjustment of the source of subjects; “two-step” implementation of epidemiological screening; detection of COVID-19 antibody and nucleic acid before admission and strengthening the management of subjects during hospitalization et al. Results A total of 14 clinical trial projects screening 1,638 patients and enrolling 585 patients were conducted from March to December 2020. All the trials were completed and no COVID-19 infection occurred. Conclusion During the COVID-19 epidemic, measures including improving the prevention and control management system, strict implementation of the screening and admission and strengthening the management of subjects are conducive to the safety of subjects and medical staff and the smooth progress of the Phase I clinical trial.

Key words: COVID-19, prevention and control, phase I clinical trial, subject management