薬理と治療

Abstract

Background　We started to utilize cloud system for management of safety information in investigator‒initiated clinical trials. Investigators were able to select from“hand‒written signature”“, typed signature; fill in investigator’s name on the response form”“, digital signature” methods for replying to their opinions. We expected that utilization of“digital signature”leads to operational efficiency. Objectives　The aim of this study was to investigate operational efficiency of digital signature. Methods　The median number of days to investigator’s reply, the difference between approval date and reply date, the rate of reminder, and problem cases were investigated by archival records of e‒mail and cloud system. Results　The median of days（75th percentile, 25th percentile）to investigator’s reply was 1 （0, 4）for hand‒written signature method, 1（0, 2）for typed signature method, and 0（0, 1） for digital signature method. The rate of reminder was 6.1％ for hand‒written signature method, 4.2％ for typed signature method, and 3.8％ for digital signature method. Conclusions　This result suggests that digital signature methods contribute to prompt sharing and reporting, and operational efficiency. （Jpn Pharmacol Ther 2023；51 suppl 1：s32‒37）