Clinical trials with human subjects are regulated by several different national and international organizations to protect the safety and welfare of human subjects in clinical research. In particular, the International Conference on Harmonisation (ICH) provides the research community with Good Clinical Practice guidelines (GCPs), a set of standards for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials.
In November of 2016 the ICH updated its GCP guidelines, E6 (R2), to reflect evolutions in technology and risk management processes in an effort to increase efficiencies in clinical trial operations. While these changes are largely seen as positive, they do represent a shift in how clinical trials are monitored. As a result, clinical operations teams are re-training clinical research associates (CRAs) on the new approach defined by ICH E6 (R2) — risk-based monitoring — while maintaining compliance with a myriad of other industry regulations and organizational standard operating procedures (SOPs). It’s a lot of details to remember throughout the workday, and all in service to the most important aspect of clinical trial monitoring: patient safety.
Among the biggest training challenges that clinical operations teams face as a result of the ICH E6 (R2) risk-based approach is recall. Typically trial monitors receive regular training on a variety of subjects as its a highly skilled profession. Unfortunately, the assumption is that when learning something new that knowledge is retained and can be recalled. Many studies prove this is misnomer. One-off or point-in-time training, while valuable, isn’t a panacea for clinical operations teams tasked with overseeing ongoing trials.
The forgetting curve describes the dramatic drop off in knowledge retention over time. Studies show that in as little as 30 days, 79% of knowledge is forgotten. It is simply a matter of how the human brain works, and this concept should be factored in when planning for ICH E6 (R2) training, as with any training.
So what are training strategies that can be deployed to boost recall of ICH E6 (R2) regulations? Here are 5 proven approaches:
With so much riding on the success of clinical trials including the health and safety of patients, using proven educational approaches on the job are well suited to clinical trial manager training.
To learn more proven training strategies for ensuring compliance with ICH E6 (R2), other industry regulations, and corporate SOPs, listen to our recent Webinar, Managing Adverse Events: A Game Changer for Risk-based Monitoring.