Human Factors Call for an Improvement in the Trial Master File Process

Human Factors Call for an Improvement in the Trial Master File Process

How Using Process Thinking can Clean Up Your TMF

Viewing the world through a process-oriented perspective derived from human factors is the concept known as process thinking. Legendary management guru W. Edwards Deming once said, “A bad system will beat a good person every time.”

Nothing could be truer – especially with Trial Master Files, or TMFs.

Processes are essential in systems that enable execution of purpose. Any set of steps followed to achieve a goal can be considered a process – an objective-driven task. Deming’s quote is relevant to any industry that depends on managing complex systems, including TMFs – both traditional and electronic. Designing a quality control system to achieve a TMF that is inspection-ready must be analyzed and optimized using a process thinking perspective.

The Process Thinking Perspective

Does embracing process thinking mean that we deem humans as an unimportant part of systems? Of course not. However, this process does help recognize a key fact that is crucial to improving the trial master file process: It’s more productive to design a TMF system around humans and the way they work instead of forcing people to conform to a system that doesn’t suit their skills, talents, and needs.

This is the main takeaway of process thinking.

This type of thinking rejects the idea that the best way to solve problems is reductionism; that is, breaking down a problem into tiny parts. Why would this be a bad thing? Because reductionism produces blame. Blame is such a damaging risk to effective problem-solving. As human factors guru Keith Doricott points out, “Blame is corrosive. Most people don’t want to open up in an environment where people are looking for a scapegoat, so your chance of getting to root cause is much less.”

Blame robs us of the opportunity to learn from our mistakes.

The TMF Process and Blame

An important part of process thinking is the 85/15 rule, developed by early quality improvement pioneer Dr. Juran. The rule proposes that for every problem in a system, 85% of the problem lies within the configuration process, and 15% of the issue is controlled by employees.

While the rule is not a statistically backed rule, it does encourage people to recognize that most employees do not have the know-how and/or the authority to wrestle with a process that is flawed. We must change our thinking from focusing on human culpability and instead turn our attention to process improvement if an inspection-ready TMF is going to be achieved.

The Difference between Blame and Process Thinking

One common TMF issue is duplicate documents. On a fairly regular basis, massive amounts of duplicates are created when people file multiple copies of the same document. It happens either in the exact same artifact folder or in multiple ones.

Let’s look at an example of how blame and process thinking would each see the issue:

  •         Blame would point the finger at clinical trial assistants (as an example), blaming them for sending the same documents over and over. They don’t check to see if it’s in the file already because they are lazy. Blame places people as the root of the problem with the TMF.
  •         Process thinking would instead take the situation and conclude that yes, they don’t realize it’s already in the TMF, but why? Because they can’t remember every single document and didn’t check what was already there. Perhaps they didn’t check because they are too busy, and it takes a long time to check.

Process thinking then would bring us to the conclusion that the root of the problem is not the people! We would see that the real cause is that it takes a long time to check what is already filed. It would reveal that the eTMF system makes it difficult to visually compare documents.

We see that process thinking presents a problem with the system, not the people; we can then move forward to find and execute a solid plan to revise the system, which is much more effective than “revising” people to work with a system that isn’t tailored to their skills and needs.

When Modern Tools meet Outdated Processes

So, now you have a new way of thinking about your TMF, and perhaps you’ve also gone ahead and upgraded to electronic trial master file systems; good for you. Take a look at your eTMF processes, though – have they changed as well over the past years? If not, you may be unintentionally placing process improvement on lockdown.

Much of the stagnation involving processes can be attributed to the need to meet regulatory requirements – requirements that were designed for paper TMFs decades ago. For this reason, it’s critical that eTMF leaders be given the green light to pursue process improvement while risking regulatory infraction.

Current processes can be improved by:

  •         Focusing on basic processes
  •         Focus on what should be, not what is
  •         Confirming that TMF tools work well with other everyday tools
  •         Creating user interfaces that increase transparency
  •         Making it easy to discover and correct mistakes
  •         Using process thinking to discover problems and resolve them

While antiquated regulations can be held accountable for part of the cause of difficult TMF systems, people are also partly to blame. Changing the way we approach our TMF systems and problems is the first step to improving the process; moving from playing the blame game to using process thinking will open the door to a whole new level of TMF improvement. Ultimately, if people are unhappy with the TMF process that is being used, it’s time to change it.

Learn more about improving TMF processes at one of our upcoming TMF summit. Space is limited, so don’t delay.


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By |2019-06-20T20:53:33-04:00June 7th, 2019|

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