GCP AND PV TRAINING THAT DOESN’T SUCK

GCP and Pharmacovigilance training is a requirement for all sites that participate in clinical trials. Non- compliance with ICH GCP E6(R2) regulations results in inspection findings, cost overruns, data rejection, and potential study delays. As a result, sponsors often require that sites take their specific GCP and PV training, so investigators wind up taking the same training again and again. These modules are often delivered face-to-face at sites with slides or through eLearning. Research shows that we only retain 20% to 30% of verbal information whereas with simulation / experiential learning, we retain 70% to 90%.

The Pro-ficiency GCP and PV training uses real-life scenarios in an online simulated environment. The better the learners know the material and the more they pay attention to the training, the faster they can get through it. Like in a choose-your-own-adventure novel, site staff make their way through realistic scenarios that cover the principles of GCP and PV in an entertaining way.

In fact, 76% of 1701 site staff learners “Liked” or “Loved” the Pro-ficiency simulation-based GCP training while 20% said is “OK” and only 4% preferred eLearning or face to face training. We are doing something right when thousands of investigators tell us that they LOVE our GCP training!

This Pro -ficiency training is an improvement on traditional training (meetings, slides, videos).

83% agree

10% undecided

7% prefer traditional methods

Predictive Analytics (real-time access)83% agree

The Pro-ficiency dashboard shows investigator performance in the training simulations across dozens of critical protocol and GCP metrics (the vertical columns). A blue checkmark indicates that a specific decision was made appropriately. If the learner makes a mistake, then a brief video -based corrective action is launched and they get a yellow icon. If the learner makes that same mistake again, they get a red icon. Lots of yellow icons indicate that, while knowledge gaps were identified, they were also easily corrected. Lots of red icons means those investigators are either not trying or they are having real problems understanding the protocol.

Based on the performance of the 2 sites above, which one would you trust more with your protocol and expect better performance from? 7% prefer traditional methods