We ran a workshop on QTLs in 2022 and were inundated with questions. So we thought we needed to return to the subject! We will explore the latest thinking on QTLs, discuss why organizations find them so challenging to implement, suggest practical approaches, and have plenty of opportunity for lots more of your questions.
Describe and discuss the practical challenges with risk assessment. How many risks should you have? Should risks that are for multiple studies be included? Should you only include risks that are study specific? Should the impact score be based on the impact of the whole study or individual patients?
mindsON RBQM | Episode 14: RBQM implementation - Which existing roles need change, and what new ones are required?
Since Risk-Based Monitoring was introduced in 2013 by FDA and EMA, organizations have taken many different approaches to implementation. What activities typically need to be performed for RBQM to work well? Which roles usually perform these activities? What new roles are typical, and what has happened to existing roles?
How much of RBQM can be standardized, and how much flexibility is still necessary? Some companies seem to always start from scratch, while others try to standardize as much as possible. What is right and what is wrong with the two approaches? And how can you get the balance right?