Evaluation of Data Errors and Monitoring Activities in a Trial in Japan Using a Risk-Based Approach Including Central Monitoring and Site Risk Assessment

• Published in: Therapeutic innovation & regulatory science Vol. 55; no. 4; pp. 841 - 849
• Main Authors: Kondo, Hidenobu, Kamiyoshihara, Tomoaki, Fujisawa, Kenji, Nojima, Toshiaki, Tanigawa, Ryohei, Fujiwara, Hisataka, Suganami, Hideki, Hayashi, Yukikazu, Yamaguchi, Takuhiro
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.07.2021; Springer Nature B.V
• Subjects: Clinical trials; Drug Safety and Pharmacovigilance; Evaluation; Fear; Medicine; Monitoring; Onsite; Original Research; Pharmacotherapy; Pharmacy; Risk assessment; Strategy; Switching; Technology; Japan; Risk-based monitoring; Central monitoring; RBM; Site risk assessment
• ISSN: 2168-4790; 2168-4804; 2168-4804
• DOI: 10.1007/s43441-021-00286-9

Background Risk-based monitoring (RBM) is a slow uptake in some trial sponsors. There are three main reasons for this. First, there is the fear of making large investments into advanced RBM technology solutions. Second, it is considered that RBM is most suitable for large, complex trials. Third, there is the fear of errors in both critical and non-critical data, appearing as reduced on-site monitoring is being conducted. Methods Our RBM team identified, evaluated, and mitigated trial risks, as well as devised a monitoring strategy. The clinical research associate (CRA) assessed the site risks, and the RBM team conducted central monitoring. We compared all data errors and on-site monitoring time between the partial switching sites [sites that had switched to partial source data verification (SDV) and source data review (SDR)] and the 100% SDV and SDR sites (sites that had implemented 100% SDV and SDR). Results Partial switching sites did not require any critical data correction and had a smaller number of data corrections through on-site monitoring than the 100% SDV and SDR sites. The RBM strategy reduced the on-site monitoring time by 30%. Conclusions The results suggest that RBM can be successfully implemented through the use of site risk assessment and central monitoring with practically no additional investment in technology and still produced similar results in terms of subject safety and data quality, as well as the cost savings that have been reported in global complex studies.