薬理と治療

Abstract

Background and Objectives In order to achieve a data quality monitoring in investigator‒initiatedclinical trials with limited resources, the development of an efficient, low‒budget, andhigh‒quality monitoring method is required. We reported a new monitoring method which weapplied to the quality monitoring of an international and investigator‒initiated multi‒centerclinical trial.Methods We retrospectively reviewed the monitoring reports of Antihypertensive Treatmentof Acute Cerebral Hemorrhage（ATACH‒Ⅱ）trial in Japanese sites and examined the efficacyof the new monitoring method by combining on‒site and remote monitoring using a web‒conferencesystem. Additionally, we compared the data quality of the sites with clinical researchcoordinators（CRC）to those without CRC.Results We monitored 209 cases in 13 Japanese sites from May 2013 to February 2016. Support from CRC was available in 6 sites. Remote monitoring was useful to verify the source documents, however, on‒site monitoring was needed to check the adverse events. The voluntary reporting rate of adverse events was higher in the sites with CRC than those without CRC （60.7％ vs 25.8％）. Conclusions Remote monitoring in combination with on‒site monitoring was useful to save human resource and budget. Proper understanding of the concept of adverse events may extend the possibility of remote monitoring.