Hi Everyone,
I wanted to give you a bit of my Research background.
I am a Registered Nurse having worked in Critical Care since 1987, in Toronto, ON. I have been in research beginning as a study nurse through progressive promotions up to Director of Clinical Research in a small start up biotech company.
I have had the privilege of working with some of the best FDA and Health Canada Inspectors. I have learned many tidbits over the many years.
The key take away from my blog is to set you up for success! In my experience, there is always a patient at the end of any discussion. I consider they are a family member of someone I may have worked with. With that said, I always try to do the right thing.
I endeavour to ensure to do the right thing, the first time. I don’t believe in wasting time, nor doing things twice. We don’t like to go back to anything, and so, if it’s done right from the beginning, we won’t need to go back to anything.
Remember, as a Registered Nurse, we work under the premise of, “if it ain’t documented, it ain’t done! ” So Document, Document, Document! You need to remove the need for ANY questions from a CRA, or Inspector.
That is my little schtick for now.
Any questions, please ask, I’m here to help!!