u/SpareThink2632

What is it with all the IE's?!

When I was at site, having an IE would have been a very serious thing. I would have had meetings with management. Quality would have been very involved. It never happened in my time.

Some sites appear to be barely reading the in/ex. Worldwide sites, experienced sites, new sites. The computer didn't work so I did it on paper instead. It's how I do it on another study so I did it on this one too. Requests for waivers.

It appears the opinion is often - ask for forgiveness not permission.

Anyone have experience of how this affects the final data readout? I'm sure the regulators won't be impressed. Anyone ever had to increase a sample size due to IE's?

Thanks