mindsON RBQM | Episode 1 – Critical Data & Critical Processes

Kickstart your RBQM journey with expert guidance on core concepts, practical applications, and proven strategies for success in clinical trials!

Consider unlocking the Essentials of RBQM: Invest in the mindsON RBQM Episodes 1-7 Bundle, find more information here…


Learn to manage critical data and processes in clinical trials. Kickstart your Risk-Based Quality Management journey with Episode 1 of our mindsON RBQM series: Critical Data & Critical Processes.

This episode dives into the crucial first steps outlined in Section 5.0 of ICH E6(R2) for implementing RBQM in clinical trials. Our expert instructors, Keith Dorricott, MBB, and Johann Proeve, Ph.D., guide you through the best practices for identifying critical data and processes in clinical trials, empowering you with the essential knowledge every risk-oriented clinical expert must possess.

The mindsON RBQM Episode 1 has six individual on-demand lectures that analyze critical data and processes within clinical trials. These lectures delve into several crucial topics, including identifying the optimal starting point between critical processes and critical data, leveraging critical endpoints to distinguish critical data, and determining the underlying procedures for capturing and guaranteeing the precision of critical data. Collectively, the lectures offer a detailed breakdown of subtopics under critical data and processes in clinical trials.

About mindsON RBQM

mindsON RBQM is a comprehensive workshop series that focuses on the practical elements of RBQM implementation and everyday execution. It offers an extensive array of resources to give you the tools you need to be successful in this industry. You can easily fit e-learning into your busy calendar thanks to each episode’s numerous brief lectures, none of which last longer than 12 minutes. The format of this series is based on the popular live mindsOn workshop series. The series includes interactive elements, such as polls, thinking, and quiz-type exercises. These elements challenge learners to comprehend the RBQM concept fully. Furthermore, the training courses offer insightful viewpoints and stimulating discussions. By including an engaging problem-solving activities, this series helps learners overcome the challenges and complexities of RBQM in clinical trials.

If you want to learn more about practical implementation of risk based quality management strategies? Be sure to check our other courses here.


  • Identifying relevant Critical Processes for RBQM
  • Determining the stakeholders that should be involved
  • Understanding how Critical Processes can differ from study to study and be formalized
  • Defining Critical Data even before the eCRF is established
  • Exploring the influence of Critical Data on KRIs

Who should attend?

  • Clinical Project Managers
  • Clinical Research Associates
  • Data Managers
  • Quality Assurance Professionals
  • Regulatory Affairs Specialists, Medical Monitors
  • Site Managers
  • … and all other Clinical Research Professionals

Why should you attend?

Unlocking the Foundations of RBQM | Don’t miss this opportunity to solidify your understanding of Critical Data & Critical Processes in RBQM. Join Episode 1 of the mindsON RBQM series and take the first step towards mastering Risk-Based Quality Management!


For You


*Courses are limited to 1 item per person. For purchasing for a team, please get in touch.

For Teams

Get in touch

Related Products

Do you want to make the most of your RBQM journey?

Sign up to get notified of any new courses, workshops or webinars!