Development of new computer system validation method for ICH-GCP clinical trial

2017 Fiscal Year Final Research Report

• Project/Area Number: 26560270
• Research Category: Grant-in-Aid for Challenging Exploratory Research
• Allocation Type: Multi-year Fund
• Research Field: Medical engineering assessment
• Research Institution: Osaka City University (2016-2017); Osaka University (2014-2015)
• Principal Investigator: YAMAMOTO Keiichi 大阪市立大学, 大学院医学研究科, 特任准教授 (70416387)
• Project Period (FY): 2014-04-01 – 2018-03-31
• Keywords: 医療技術評価 / 治験 / 規制適合

Outline of Final Research Achievements

For the investigator-initiated clinical trial, we finished the system validation project with a new validation method. We also built a group to conduct validation in the academia. In addition, he advocated a new validation method in academia, gave academic presentations and writings, raised awareness of its importance until the symposium was held at related academic conferences. Therefore we believe that we achieved our initial goal of this research. Utilization of IT technology is indispensable for increasing efficiency of clinical research. We hope that the establishment of a CSV methods based on the current situation of ARO in our country which will be addressed in this research leads to improvement of reliability of clinical research in Japan.

Free Research Field

医療情報学