In response to the rising complexity and cost of clinical trials, the industry is shifting towards the adoption of Risk-Based Monitoring (RBM) approaches. RBM promises to improve both clinical trial efficiency and data quality.
Q1) Are the indicators percentages? E.g., % AEs for the site v study or just number (which could indicate that there are many AEs as there are many subjects)
The units for each KRI may be different. In the example of AE Rate, we suggest computing a rate of AE’s per patient visit.
1: What is the biggest challenge that your organisation faces in successfully rolling out Risk-Based Monitoring?
Internal change management
Lack of senior leadership support/ buy in
Defining new roles and responsibilities
Getting all of the RBM processes defined and agreed
Acquiring a budget to implement RBM