국가임상시험지원재단

● Overview of TransCelerate RBM Methodology

Masato Kobayashi(Astellas, TransCelerate representative)

Since ICH E6(R2) has been released, sponsors have to follow this new concept of risk based approach in clinical trial. In parallel, TransCelerate Biopharma inc, has discussed how we realize this risk based approach in clinical trial. And TransCelerate Biopharma inc, released concept paper of RBM Methodology. Since Astellas Pharma Inc is one of Member Company, we implemented this concept and developed our Risk based monitoring process including Risk assessment & management and Centralized monitoring. Then, I overview this TransCelerate RBM Methodology to understand this concept. I believe it’s good first step to implement RBM methodology in your organization or reconsider it again if you already implement RBM methodology.

●  Key Role of Centralized Monitoring - Going forward in RBM -

Yumi Sugiura(BMS)

With 5 years experiences of adopting Risk-Based Monitoring (RBM) methodology to site monitoring at BMS, there are some lessons we have learned. International Conference of Harmonisation (ICH) E6 (R2) was updated because of the increased use of technology in clinical trials, making real-time site performance and quality assessment more feasible. One of the most notable changes to ICH E6 (R2) guideline is the quality management recommendations outlined in the Section 5.0, focusing on subject protection and the reliability of the trial results. RBM is part of Quality Management approaches, which can minimize or control risk through proactive risk assessments by using current medical and statistical knowledge, historical data from similar trials and the known or anticipated risks of investigational product.
This session will address key components to successful implementation of Centralized Monitoring, which drives quality oversight commensurate with the important risks and helps prioritize the monitoring strategy.
This session will address key components to successful implementation of Centralized Monitoring, which drives quality oversight commensurate with the important risks and helps prioritize the monitoring strategy.

● What Other CRA Capability Should be Required in a New RBM Process?

Barbara Grassi(GSK)

The evolution of site monitoring mainly driven by Risk Based Monitoring (RBM) and Central Monitoring has entailed Sponsors and CROs to redefine CRA capabilities (technical and behavioural), expectations and ways of working. Different companies might be at different stages of this journey and might implement differently depending on their operating model for clinical trial conduct, but in the end, all seem to envisage CRAs to truly embrace the principles of risk management, flexible approach to site monitoring (on site visits, off site visits, remote monitoring) new technologies and, as a foundation, to be proficient in analytical skills. Implications are gap analysis and training programs to develop those capabilities for people currently in the job, but also incorporating those capabilities and expectations in the job descriptions posted for new hires. The presenter will also provide her perspective on what’s next beyond RBM that could constitute an inflection point for further evolution/transformation of the CRA job. 

1. Masato Kobayashi(Astellas, TransCelerate representative)

2. Yumi Sugiura(BMS)

3. Barbara Grassi(GSK)

상기 과정은 보수과정으로 직능별, 단계별 인정가능시간이 상이함으로 관련규정 '[별표1] 임상시험등 종사자별 교육과정 및 이수시간'을 꼭 확인하시기 바랍니다.

[별표 1]

임상시험등 종사자별 교육과정 및 이수시간

(제5조 관련)