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Re: flipper44 post# 315784

Friday, 10/09/2020 10:04:29 AM

Friday, October 09, 2020 10:04:29 AM

Post# of 539681
I just got off the phone with the clinical trial regulation department EMA.


She confirmed that NO changes to clinicaltrialsregister.eu can be made directly by the sponsor. She told me that indeed only approved changes such as endpoints are submitted to the clinicaltrialsregister.eu IF the national health organizations in the specific countries have allowed and approved such.

In the case of NWBO she confirmed that this has been recently done so.
Also, she confirmed that in the case of NWBO this has been done so by the NHS in the UK and PIE in Germany.

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