Posts

Happy 20th anniversary, ICH-GCP!

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

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ICH GCP and the Declaration of Helsinki

A relationship gone south?


ICH GCP will have it’s 20th anniversary this year, with the first real update in advanced stages of preparation. It’s aimed at being adopted in November this year1
. Where GCP in it’s introduction states that the principles ‘have their origin in the Declaration of Helsinki’, the Declaration (DoH) has evolved significantly in the past 20 years and not without controversy. So where does ICH, and for that matter some of their official parties, stand on the current DoH?

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Introducing: Your GCP nerd

Well… it’s 2016! Time to put my writing where my mouth is… So, without further ado: “Introducing: Your GCP Nerd”, Eric Klaver!

For the longest time I’ve referred to myself as the ‘Self-Proclaimed GCP Nerd’… Well, in honesty, course participants started. But I found it to be a compliment worthy of adopting!

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