To get a RBM project started, Newbigging outlined these steps:
- 1) Identify attributes of a clnical protocol
- 2) Identify key risk areas
- 3) Categorize risks into an Integrated Quality Risk Management Plan
After these things are set into play, a trial can then be monitored by both operational data and and trial data. KRIs can then allow the monitors to identify the risks of each trial and change them from afar. By using RBMs and the three criteria above, fewer sight visits will have to be made and will reduce the over all cost of site monitoring. It will also improve the quality and security of the projects in the long run.
Read the full article here. Do you feel that the high cost of implementation for risk based monitoring will be outweighed by the benefits that central monitoring brings to a clinical trial?
This April at Partnerships in Clinical Trials, we will have the full day working group dedicated to Risk-Based Study Management. For more information and a preview of this study, download the agenda. As a reader of this blog, when you register to join us and mention code XP2000BLOG, you can save $100 off the current rate.