101 Things That Could Go Wrong If You Don't Get Your Clinical Study Training Right

By Beth Harper, Chief Learning Officer at Pro-ficiency

Although it can be tricky to acquire proper clinical site training, inadequate planning for a research study’s training needs will create unnecessary, avoidable costs down the road. Let’s take a look at a not-so-uncommon scenario. You budgeted about $20 million dollars to complete your Phase III clinical trial.  You spent months fine-tuning the protocol to perfection.   All of your third-party vendors are engaged and their systems are operational.  Regulatory and ethics approvals are expected any moment and the investigational drug is at the depots ready for distribution. Your investigational compound is meeting an unmet medical need so your clinical sites are especially motivated to start enrolling.  In fact, 100% of the site staff have completed their required online training modules – a first in your organization’s history!  What could possibly go wrong?