Abstract
Background The digitization of clinical trial documents has been promoted in Japan. The Clinical Trial Document Support System (CtDoS2) was widely used for electronic document management but has been discontinued in March 2023. This study aimed to assess the changes in the usage rate of electronic systems, their strengths, and weaknesses before (February 2023) and after (February 2024) the discontinuation of CtDoS2.
Method We conducted a questionnaire survey to examine the status of the introduction of electronic systems and the status of their contracts with CtDoS2.The survey was conducted among clinical trial office staff at PMDA IRB-registered institutions as of November 30, 2023.
Results A questionnaire survey was performed among 1244 clinical trial offices, and the response rate was 30.1%. The usage rate of electronic systems increased from 15.2% in February 2023 to 25.3% in February 2024. The usage rate was higher in facilities that had contracts with CtDoS2 compared to those without. Facilities that introduced electronic systems reported advantages such as reduced paper usage and decreased work hours, and their satisfaction levels were high. Both the dissatisfaction among facilities that introduced electronic systems and the reasons for non-introduction among facilities that have not introduced electronic systems included cost issues and the burden of creating regulations and manuals.
