11/6/2013

I am presenting a workshop on Facilitation Skills for site management the next two days. So, I just spent many hours updating my course on Facilitation Training for Site Management to include some of the concepts of quality risk management, but I realized skilled facilitators that apply the core concepts and process tools of facilitation are in a good place for this transition of more remote management and may have not noticed as much change in their approach to site performance management. For example, I have taught site managers (e.g., monitors) to source document review for years. We termed it SDV: we lumped it under source documentation verification. The training was NEVER to promote simply verifying data was the same from source to CRF (what a mindless activity), but to rather map the performance of site GCP responsibilities, e.g., protocol compliance, adverse event reporting, effective process and preventive action implementation. SO, I admit it, when I saw the separation of SDV from SDR I got a little defensive.

I used to occasionally follow a monitor that did merely "SDV" and not facilitate corrective action when that SDV revealed deviations, human subject protection issues and more. Critical Thinking...those golden opportunities to work with a site to assess the impact of deficiencies, root cause and effective interventions that if the issue was systemic would prevent it from occurring on this and another study. Yes: being a skilled facilitator is critical, and you should have more time to apply the process interventions with an effective risk-based approach. SO, facilitation: a critical soft skills set that focuses on process improvement and not merely checking the box.