Changes

Guidance
My version of the Bible: I keep this abridged version of the regs on my nightstand. I refer to it for occasional guidance every now and then.  I never thought I’d be as interested as I am right now in reading and referencing this book.

The FDA has released some guidance on the Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic (click on the link below if you’re interested):

FDA Guidance

For a downloadable PDF, click on the following link: Clinical-Trial-Conduct-during-COVID-19-Direct-to-Final-3-17-20

Also, I’m super proud to be part of the team at the company I work for. They are using the ever-changing daily guidelines by regulatory authorities and health institutions to make adjustments as needed. #clinicalresearch #teamwork