06/09/2014

Check out the Risk-based Monitoring Round Table Discussion:

The Journal for Clinical Studies Volume 6. http://jforcs.com/ find Volume 6, page 19.

"There are many opportunities where root cause analysis (RCA) can be used in running clinical trials, but not just for non-compliance root cause assessment. Another important opportunity to use root cause analysis is in an anticipatory environment. Here, RCA can support the conciliatory effort of sponsor and/or investigational site cross-functional teams to identify why something could go wrong within a study, and link interventions directly to the root cause(s) to better mitigate risks, especially those linked to risks to human subject protection, quality data and project milestones (e.g. RCA used during early project planning, study start-up risk assessment and action planning to develop study plans). The use of RCA is also crucial in determining the essence of change, and what it will take to support it (e.g. integrating clinical quality risk management in GCP). Additionally, RCA can help to develop both the workforce and the strategy involved in future state goals (e.g. risk management skills within a GCP environment, reorganization of a clinical research department function, in support of a product development plan). Go to the journal to read more or contact Clinical Pathways for more information."