Root Cause Analysis Opportunities for GCP


Root cause analysis (RCA) is an important process that is not inherent and involves scientific principles. Tools used to perform RCA (e.g. 5 Whys, fishbone diagrams, cause mapping, force field analysis, etc.) do not teach an individual how to perform RCA. RCA, instead, must be taught and practised. RCA is a process that is part of performance management.

In order to determine the cause of performance gaps, a person should assess the primary environmental and individual performance factors (also known as system and project level) that must be in place to support any performance for any project where you are depending on others to perform critical functions for you, such as a clinical study. Interventions assigned to address deficiencies must be based on the root cause(s) (i.e. at least one root cause for each intervention or set of interventions), in order to be effective and prevent issues from occurring or recurring.
It is imperative to include evaluation design in the interventions so that performance can be measured, and assess whether RCA was performed well. RCA also focuses on addressing the systems level factors - again to promote improvement.

RCA analysis within clinical trials is primarily formally used when implementing CAPAs internally or externally linked to other stakeholders (i.e. sponsor to investigator, sponsor to CRO). But with the industry focus on building better clinical quality systems that include risk management, the use of proactive RCA at all levels of performance management in clinical trials is essential (e.g. during risk assessment).

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).

Instead of being primarily reactive and trying again and again to fix similar problems, it is critical to put the RCA at the front end with risk assessment and action planning. It is important to recognize the role of RCA in good clinical practice (GCP) and RBM today.