“Sites need to be aware that participating in clinical research carries risk.”
Never overlook the “human factor” when a potential study sponsor comes to visit your site. It can win or lose you business every time.
Mistakes in clinical trials happen. But we “can learn to mitigate risk with better study preparation.”
“The biggest risk in risk management is not having a risk management plan.”
Gaining FDA approval for an Investigational New Drug (IND) application is not a thumbs-up to conduct a clinical trial however you like.