Let's Get Clinical, Tips From The CRA Helper

Principal Investigator Oversight

April 24, 2020 Elizabeth Episode 14
Principal Investigator Oversight
Let's Get Clinical, Tips From The CRA Helper
More Info
Let's Get Clinical, Tips From The CRA Helper
Principal Investigator Oversight
Apr 24, 2020 Episode 14
Elizabeth

#014 – In previous episodes I reviewed the Delegation of Authority Log. Although the PI maintains this list of appropriately qualified persons to whom he/she has delegated significant trial-related tasks, it is important to remember that the PI is ultimately responsible. The PI is more than just a signature and is responsible for overseeing all site activities. We as monitors, must ensure that the PI at each site is involved, and appropriately overseeing the study. In my career I have seen various levels of PI involvement, from one extreme to another!! Join me, as I share some experiences from my own monitoring journey, as well as helpful tips in verifying PI oversight.

Show Notes

#014 – In previous episodes I reviewed the Delegation of Authority Log. Although the PI maintains this list of appropriately qualified persons to whom he/she has delegated significant trial-related tasks, it is important to remember that the PI is ultimately responsible. The PI is more than just a signature and is responsible for overseeing all site activities. We as monitors, must ensure that the PI at each site is involved, and appropriately overseeing the study. In my career I have seen various levels of PI involvement, from one extreme to another!! Join me, as I share some experiences from my own monitoring journey, as well as helpful tips in verifying PI oversight.