Summary of TransCelerate’s Update to its Risk-based Monitoring Position Paper

The 7-page document provides an update on TransCelerate’s Risk-based Monitoring (RBM) initiative.  It includes a list of lessons learned, shares FDA feedback on RBM pilot studies, and provides links to RBM training developed by TransCelerate (TCB) member companies.  It also outlines 2014 publishing plans.

Some of the main lessons learned are associated with the risk assessment conducted on the program and protocol.  TCB emphasizes how important it is that a cross-functional team perform the risk assessment, so that multiple aspects of the drug development process can be represented.  Also, experience showed that the earlier in the process the risk assessment is conducted, the better.

In addition to these lessons learned from experience, FDA provided some important feedback about RBM pilot studies, such as:

• Risk assessments should focus on a few additional areas (e.g., compliance with dosing regimen)
• Threshold values for triggering further action (and what that action is) should be specified
• Risk Indicators and thresholds should be measurable
• Monitoring plans should specify required activities that must be done on-site, off-site, and centrally
• RBM’s impact to other programs, such as SOPs on vendor oversight and drug supply chain, should be considered
• Site training about the application of RBM should be considered

I was particularly pleased to see that TCB has developed training modules for the many RBM stakeholders, including train-the-trainer manuals, a participant workbook, and recommended pre-course/post-course work.  The 5 training modules cover:

• Intro to RBM
• RBM Methodology and Team Member Responsibilities
• Methods for Risk Assessment (including use of RACT tool)
• RIs and Threshold in Decision Making
• Change management for transitioning from traditional to RBM model

There are many more TCB RBM publications planned throughout 2014.