Good Clinical Practice Guide
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Thread: ICH GCP E6 (R2) Addendum

  1. #11
    Forum Member
    Join Date
    Nov 2011
    I would not worry. Step 5 is the only one you should use. I seem to remember that there were either no changes or only cosmetic changes between 4 and 5. that's not surprising given that step 5 is just each region publishing the final agreed text of ICH. So for instance the EMA had an implementation period on the front. The FDA just put the date they published it (which was later than EMA!).
    Thing to watch out for now is R3!!!

  2. #12
    Hi Dorothea. My understanding is the following: step 4 means the guideline is content final and agreed within the ICH organization. Step 5 is the official adoption by the member countries - without content changes. But the content is transferred e.g. to the FDA Guideline Format and get's - most important - a coming into effect date (specific for the country). Hopefully this helps.

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