電子的遠隔SDV (RSDV) についての成果と課題

Abstract

Electronic remote source data verification (RSDV) allows on-site SDV to be performed in a remote place. To use the telecommunication system for such purpose, it is necessary to solve various problems such as personal information protection, data security, operating labor, and cost. In the present study, clinical trial sponsors cooperated in a pilot study of RSDV, which clarified the benefits and identified new problems. We also conducted a questionnaire to investigate the sponsor's satisfaction with the labor involved and the performance for full-scale implementation of RSDV. RSDV was performed using PDF and special code software (FinalCode®) to investigate the performance and problems. The SDV implementation time per SDV in the medical institution (on-site SDV; OSDV) decreased definitely. However, RSDV had little impact on decreasing the number of times of OSDV, a benefit that was greatly anticipated. From the viewpoint of work density, the quantity of verification data for one OSDV was doubled by the introduction of RSDV. The questionnaire survey showed that, in general, introduction of RSDV increased the convenience of SDV per se. Because all monitors perceived convenience, especially in full support, the survey indicated that convenience outweighs the labor and cost of RSDV. Although this pilot study showed a tendency of decrease in number of SDV, a substantial reduction was not observed. However, the on-site function of re-verifying data that had been confirmed beforehand was well developed, showing a behavioral pattern toward improving the quality of SDV over the time-saving factor. More efforts to improve the efficacy of RSDV would become a driving force to activate clinical trials. (Jpn J Clin Pharmacol Ther 2013; 44(2): 71-76)