Risk-based Monitoring

Gain hands-on practical experience on the Risk-based Monitoring tool and upgrade your skill set today.

Overview


Why Risk-based Monitoring

Traditional methods of clinical trial monitoring are seeing rising costs and complexities involved due to ineffective and resource-intensive methodologies. Risk-based monitoring is taking over as it promises greater accuracy, lower costs, in-depth analysis and timely results.

In This Course

Learn the different aspects of RBM including Risk Identification, Evaluation, Control, Review and Reporting, vendor selection, QbD and The Site Perspective of RBM. It will touch upon FMEA, KRIs, the RACT, existing models of monitoring, and why regulators are supporting an RBM approach.


The Sollers Advantage

The Short-term Program in Risk-based Monitoring by Sollers is taught by faculty experienced in the industry. The program is a great way to quickly develop an in-demand skill and gain valuable hands-on experience working on the Risk-based Monitoring tool.

Syllabus

  • Explain the rationale for Risk-Based Monitoring (RBM)
  • Describe TransCelerate’s founding principles and key assumptions
  • Describe the Risk-Based Monitoring (RBM) methodology as compared to traditional monitoring methods
  • Discuss methods for identifying risk for planning purposes
  • Identify Critical Data/Processes for Risk-Based Monitoring (RBM) application
  • Define and utilize Risk Indicators and Thresholds in decision-making
  • Discuss implementation of risk mitigation plans
  • Identify site-level risks
  • Describe how to conduct monitoring activities in the RBM model – including central, offsite and on-site monitoring
  • Describe appropriate responses to potential issues and risks throughout the study
  • Discuss considerations with implementation within an organization and at sites
  • Describe metrics used to measure the impact of the proposed methodology
  • Inform investigative sites about the Risk-Based Monitoring (RBM) model
  • Describe metrics used to measure the impact of the proposed methodology
  • Apply effective transition techniques for studies and sites
  • Discuss challenges with implementation within different culture and systems

Instructors

Our instructors are not just highly experienced in the industry, they give you the personal attention you need and guide you every step of the way.

Kamal Akhtar

Faculty of Clinical Research


Dr. Nimita Limaye

Faculty of RBM


Course Duration

Starting soon

Reserve your spot

Engagement

45 hours

For information regarding fee and/or reserving your spot, contact our Admissions Team.

OUR STUDENTS WORK AT

Sollers partners with industry-leading corporations and provides them with ready-on-day-one employees. We record an 82% placement rate within three months of graduation.

Financial Options

Sollers has devised viable financial options for you to ensure tuition does not get in the way of your education. Now, you can focus your attention where it needs to be – in the classroom!

Career Guidance

After the completion of program, we assist our students with interview coaching, resume building sessions, conduct mock interviews, job readiness training and make them competent to venture into the corporate world.

Student Testimonials

  • Emmanet T.
    The Clinical Trial Management course is extensive, and the professors are thorough in delivering the course materials using real life experience and insight. Career Services helped me throughout the interview process, and I landed my dream job with the very first interview after graduating from Sollers.
    Emmanet T.
  • Rudolf M.
    Thanks to the academic team at Sollers, I was able to gain quick admission with financial options to pay tuition. Career Services was very helpful with resume and interview prep. They sent me job postings with major hospitals and pharma companies which helped me land my current job as Data Manager in cancer clinical trials.
    Rudolf M.

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