Training is one of the most critical parts of study start-up and yet, we often treat it like a box to check rather than the foundation of trial quality. The whole point of issuing training is to ensure sites have the understanding and ability to execute a clinical trial protocol accurately, resulting in clean data, patient safety and regulatory compliance. When we push information on sites rather than truly training them on the critical elements of a protocol, we see these three factors suffer (evidenced by FDA inspections findings continuing to report ‘failure to follow the protocol’ as the top finding).
Clinical trial training doesn’t have be such a challenge, and it doesn’t have to be painful. But to improve we must identify the common culprits to poor training. In this blog post, I outline three of the mistakes we see most often in study training, and how to fix them.
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Treating training as a compliance activity instead of a competency activity.
Checking a box that someone “completed training” doesn’t guarantee they can actually execute the protocol. All it really means is they clicked through the slides or the video played until the end—there is no actual assessment of ability and understanding.
The fix? Use tools that actively engage site staff and measure performance, like case studies and critical thinking exercises.
Ask: have you validated competency and understanding, or just participation?
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Investing in systems, but not content.
Many organizations pour resources into platforms that distribute and track training—but the content looks like training slides circa 2005. Why? Because it was created by people who are outstanding at clinical trial operations but are perhaps not skilled or trained in instructional design.
The fix? Treat content creation with the same rigor as your learning systems.
Ask: does it follow sound instructional design? Does it engage? Is it simulation-driven, not slide-driven?
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Missing the opportunity to adapt monitoring strategies.
Even when robust learning outcomes are captured, monitoring approaches often fail to leverage them. Why? There are dozens of reasons that will vary based on the monitoring approach, but most often it’s due to habit, inertia, and data silos. Change is difficult in clinical trials due to the feeling that it’s safer to stick with what we’ve done in past studies, but it’s also due to data being housed in disparate systems.
The fix? Use performance analytics to target monitoring where it’s really needed. And make those analytics easily accessible to those who can use them.
Ask: What are sites not understanding? Are there regions struggling more than others? Can analytics be pushed out to those who need them or integrated across systems?
Sponsors who do this see significant time and cost savings, and sites welcome a more discussion-based IM and SIV over the 100-page slide deck presentations.
Training isn’t just about compliance—it’s about confidence, capability, and quality. By fixing these three mistakes, you can transform study training from a burden into a true enabler of trial success.
Want to learn more?