Risk Management and Root Cause Analysis.
Root cause analysis (RCA) is an important process that involves scientific principles that must be taught and practiced. 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 is a process that is part of performance management and not an inherent skills set. RCA instead, must be taught and practiced. In order to determine the cause of performance gaps, a person must use the primary environmental and individual performance factors that must be in place to support any performance for any project where you are depending on others to perform for you, like a clinical study.
Interventions 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 encourages addressing the environment or systems level factors.
RCA analysis within clinical trials is primary 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 RCA at all levels of performance management in clinical trials is essential.
There are many opportunities where Root Cause Analysis (RCA) can be used in running clinical trials, but not just for noncompliance 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 what could go wrong within a study and link interventions directly to the root cause(s) to prevent the deficiencies from occurring, especially those linked to risks to human subject protection, quality data and project milestones, (e.g., RCA used during 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 both develop 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) today.