ICH GCP E6 (R2) Addendum

[a123456]

EU has adopted R2 (Step 5) on 15 Dec2016 with a "Date for coming into effect" of 14 June 2017"

[WillC]

Another item from the Addendum worth noting (under 8.1):
"The sponsor should ensure that the investigator has control of and continuous access to the CRF data reported to the sponsor. The sponsor should not have exclusive control of those data."

One interpretation of this is that a typical arrangement where a CTU hosts their own EDC system would be non-compliant (there is no local investigator copy of the data). It would be possible to modify an EDC tool to - say - save CRF PDFs on the investigator's local network but there are obvious complications of this approach.

It would be useful to get clarity from MHRA on this, ideally before they pay CTUs a visit with a particular expectation.

[Dorothea Regina Waser]

Could somebody tell me if there is any further change in regard ICH-GCP E6 (R2) step 4 versus step 5, beside the fact that it became effective? I am really puzzled. Many thanks!

[a123456]

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!!!

[Margit Zehrer]

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.