“Retraining can only solve a problem that training created.”
When the numbers tell a different story
One sentence kept appearing in study records and reports during a recent for-cause audit: “Retrained site staff on ...” I saw it after protocol deviations, monitoring findings, documentation errors, and quality problems. Sometimes the wording changed to “site staff counseled,” but the message was always the same: Retraining was the corrective action. At first glance, that approach sounds reasonable to many.
When the sponsor requested the audit, the study had generated more than 66,000 data queries, over 530 protocol deviations, and multiple unblinding events within the first year. Yet each event was treated as unique, with little effort to identify systemic patterns. One investigation stood out:
Issue: 47% of monitoring visits out of window
Root Cause: Too many holidays
CAPA: None
While holidays may certainly contribute to scheduling challenges, they are not a root cause for noncompliant monitoring oversight. Root cause analysis should ask why holidays produced this outcome. Were workloads realistic? Were staffing models appropriate? Did monitoring plans account for regional holidays? Was oversight effective? Were triggers ignored? Without taking the time for this analysis, we might conclude that speaking to the monitors about the importance of adhering to the monitoring visit schedule will suffice as a corrective action. In such case, I imagine the sponsor will need to accept that half of the monitoring visits will be out of window for the duration of the study.
If retraining is the answer, why do the same problems keep happening?
If your CAPA begins and ends with retraining, you may not have solved the problem at all
Training is an essential component of every quality management system. Staff need to understand procedures, regulatory expectations, their responsibilities, and the impact that deviations, mistakes and errors can have on data quality and integrity, patient safety, and the conclusions of a clinical trial. Training is essential when a true knowledge gap exists.
Organizations often default to retraining because it is easy to document, inexpensive to implement, and avoids more difficult conversations about leadership, process design, accountability, resource planning, individual performance, and organizational capability. Training allows the ticking of the proverbial box that says, “We did something.”
Here’s the pitfall in this approach: What if knowledge or competency gaps are not the problem? What if the true cause of the issue is yet to be discovered? When organizations take the fast, easy way out and adjudicate problems to training issues, they are bound to miss the opportunity of addressing the real problems and will inevitably find themselves working to fix the same issues again and again.
Retraining is an intervention. Whether it is the right intervention depends entirely on whether training was the problem to begin with. By asking “What assumptions led us to conclude that retraining was the solution?” we open the doors to thoughtful root-cause analysis and the possibility of discovering the path to issue elimination and consistent compliance. Organizations don't repeat mistakes because they lack training. They repeat mistakes because they fail to eliminate the conditions that made those mistakes possible.
Organizations cannot solve problems they don’t understand
The company I audited believed they had a mature risk management framework because they monitored various operational metrics and reacted when they drifted outside expected limits. But the reality is that monitoring metrics is not a risk management activity.
It’s damage control.
Effective risk management begins before problems occur. It asks what could go wrong, evaluates probability and impact, designs preventive controls, implements those controls, and confirms they can (at least in theory) reduce both the likelihood and consequences of failure before risks manifest.
Many of the investigation reports I reviewed during the audit classified the probability of issue occurrence as Low or Medium. I asked, “How can the probability of occurrence be low or medium if the event has already happened? If the event has already occurred, the probability of occurrence was 100%” The room was shocked, but the question exposed a deeper misunderstanding. Once an event has occurred, the relevant question becomes: “How likely is it to happen again if we change nothing?” The answer to this question will lead us to identify the actions that will ultimately reduce that probability of occurrence to Low or Medium.
This is why root-cause analysis is critical. Unless we deeply understand the underlying causes of problems, we will be unable to design solutions that eliminate those causes and prevent issues from recurring.
True, responsible root-cause analysis is an exercise in courage and vulnerability. Leaders who want different outcomes should begin by asking different questions.
- Are we comfortable with the status quo?
- Do we allow others to challenge our assumptions?
- Do we provide clear instructions?
- Are our processes repeatable?
- Are our standards attainable?
- What is the data telling us?
- How do we oversee activities?
- Are we holding people accountable?
- How deep do our investigations go? Do we stop at symptoms?
Retraining should never become the default CAPA
Sustained quality performance is often viewed as the main (sometimes only) indicator of capability. In an industry that is saturated with companies that “specialize” on managing clinical trials, it is imperative that our attitude towards permanent problem solving and elimination is second to none. We are not in the business of implementing corrective actions because they are easy to implement. We are in the business of facilitating the conduct of clinical research to ultimately improve the quality of life of the patients who need these novel therapies. Every unresolved root-cause delays someone's hope. Responsible root-cause analysis and CAPA implementation tell others that we take our jobs seriously.
Tying it all together
In previous Quality Unboxed articles, we've explored why organizations solve the wrong problems, why risk management is fundamentally about disciplined thinking, and how reactive cultures become normalized.
Defaulting to retraining is where those ideas converge.
Organizations do not become healthier by documenting more CAPAs. They become healthier by thinking better.
Organizations often ask, “What’s the easiest way to get rid of this problem?” Perhaps, the better questions are “How do we become the kind of organization that no longer accepts recurring problems as acceptable?” and “What would have to change so this problem never happens again?”
That is the difference between documentation and improvement. It’s the difference between compliance and capability. And perhaps that’s why retraining isn’t always the answer. Sometimes, the organization doesn’t need another training session. Sometimes the organization simply needs the courage to think differently.
That’s the kind of thinking that fosters continuous improvement and enables the implementation of sustainable solutions that will lead to reliable clinical outcomes.