Analyzing Clinical Research Performance with Root Cause Analyses

Dawn Burke
October 20th, 2014

Though not specific to clinical research, Root Cause Analysis (RCA) is a method of problem solving that aims to identify the origin of the problem – what happened, why it happened, and how to fix it so it doesn’t happen again. Often performed as a reactive exercise (meaning problems are analyzed after they’ve occurred), it can also sometimes be used to forecast probable events before they ever come to fruition.

When analyzing a problem with RCA, it’s important to understand that events are all related to one another. The actions of one event trigger the actions of another, and so on. By backtracking through these actions, it is possible to uncover the root cause of the problem at hand. These actions can be physical (tangible, material items that malfunction), human, or organizational (a flaw in a process or workflow), and are often interconnected.

The five basic steps of the RCA process are highlighted below:

  1. Define the problem
  2. Collect data (How long has this problem existed? What’s its impact?)
  3. Identify possible contributing factors (What conditions permit the problem to occur?)
  4. Identify the root cause (What’s the real reason the problem exists?)
  5. Implement solutions (How can you prevent it from happening again? Who will be responsible for seeing it through?)

In Step 3, a common technique to identify the contributing factors is to use the “5 Whys” method. Essentially, ask why the problem is occurring, and list all possible reasons. From those reasons, ask “why” again, and from those reasons, ask again, and so on. This should be done at least five times or until the underlying source of the problem is revealed. It is important to note that there may be more than one root cause, so in that sense, RCA can be a valuable tool as a more holistic approach to solving a problem.

When facing challenges in clinical research, sites can often use RCA to trace back through the activities that led to the current problem. At the Clinical Research Operations Forum in September, Beth Harper of Clinical Performance Partners led a thought-provoking workshop on metrics. Part of the workshop required attendees to recognize key metrics and the performance issues associated with them. Then, as a group, RCA was performed. By learning the root cause of what may be causing performance issues, sites can better address them and improve their operations as a whole.

Over the next several months, we’ll be presenting a series of articles to share the results from that workshop, focusing on one root cause analysis per month. Metric analyses will range from documenting true work effort to improving study start up times to improving enrollment performance, and more. Below are the current analyses available:


1 Comment

One thought on “Analyzing Clinical Research Performance with Root Cause Analyses

  1. I enjoyed seeing RCA addressed as part of clinical research. My caution on 5-Whys is that one must know what ‘Whys’ to ask, and that it tends to be extremely linear. I have found in my practice that the TapRooT method yields repeatable results and functions well in both medical and industrial areas. Thanks for letting me comment.

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