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[V1-S3] Current Situation and Future Perspectives of Risk Based Monitoring
Session Chair(s)
Norio Shimazaki
Director, Regional Clinical Operations Japan, Korea and Taiwan, Bristol-Myers Squibb K.K., Japan
Several years have passed since many sponsors began implementing Risk Based Monitoring (RBM), however confusion continues at the site where clinical trials are still ongoing. Especially from the perspective of medical institutions, the following comments have been made: “The introduction of RBM has increased the requirements from sponsors and the number of procedures has increased”; “Some companies want to unify the method of performing RBM”. It is likely that the confusion has been caused by paying attention to only to procedures and not to what matters most: the core meaning of RBM. In this session, we will discuss the current situation and future perspectives based on Roles & Responsibilities of CRAs and CRCs and others in addition to the knowledge gained from GCP inspection in RBM implementation trials. We hope this session will help you deepen your understanding of the essence of securing Data Integrity.
Speaker(s)
Nagako Umino
Project Management Department, Technical Solution Section, I’rom Group Co., Ltd., Japan
Response to RBM - Efforts to Visualize the Clinical Trial Process
Hideaki Ueda
Associate Client Relationship Director, PAREXEL International, Japan
Risk Based Monitoring Transformed the Clinical Research Experience
Misato Kuwagaki, MS
Associate Director, Japan Data Sciences, Medical Sciences, Eli Lilly Japan K.K., Japan
Continuous Improvement of RBM Including PMDA Inspection Lesson Learnt
Yumi Sugiura, MRCP
Global Clinical Operations, Global Data Management and Centralized Monitoring, Bristol-Myers Squibb K.K., Japan
We Can’t Look Back, Only Ahead to RBM.