It’s 20 years ago already that ICH-GCP (E6)1 was formalised. An internationally accepted Good Clinical Practice guideline was born after about 16 years of national and regional GCP guidelines popping up all over the world. And 2016 marks it’s 20th anniversary!
Looking at how we got to ICH-GCP, the establishing of this guideline is almost deviant from how earlier guidelines and regulations came to be. The clinical research industry being mainly disaster driven