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To Be Prepared (or Not to Be)

Earlier this week, I posted a quote about preparation and failure. While it might seem like a trite adage courtesy of Benjamin Franklin, I believe preparation is a good idea for everything from rock climbing to filing taxes. And of course, careful planning is critical to a successful clinical trial. In two previous blogs [31-Jan-18, Risk Averse? and 8-Feb-2018, The Only Thing You Have to Fear Is…], I discussed risk assessment and risk management, including the concept of risk

The Only Thing You Have to Fear Is...

In last week’s blog, Risk Averse? [31-Jan-2018], driving to work was used as an example to alleviate anxiety about risk assessment and risk management. While that was hopefully a useful, and a bit humorous, analogy, let’s move on to some GCP specific examples this week. For this exercise, our GCP activity will be clinical investigator study site monitoring for a phase 3 registrational trial with US only study sites. The goal of the risk assessment is to develop and document t

Risk Averse?

Sometimes, when I start talking about ‘risk assessment’ and ‘risk management’ in GCP settings, looks of confusion or fear stare back at me (with an occasional yawn of boredom). Fear is a normal reaction to something new or complex that seems deeply unknowable. But risk assessment and risk management are neither of those. In fact, we all carry out risk assessments and risk management on a daily basis, multiple times a day. Here’s just one simple example: If you drive to/from w