RE: Covid 19CHIM22 Mar 2021 14:40
I am not going to bang on about this but we often submit screening protocols for subsequent studies because they are non-interventional, involve no risk to the subject and enable screening activities to start prior to approval of the main studies. In this case the characterisation study is the first study and will be a distinct and separate protocol from the screening one. The RNS in Feb informed us that the characterisation study had received Ethics approval, it did not state that they had received MHRA approval, which I believe has not yet occurred.
The proof of the pudding is that the characterisation study is not registered in Clintrials.gov and this has to be done prior to starting the study, irrespective of OO issuing an RNS or not.
The idea of them wanting to keep the study under wraps is a bizarre one, given the media coverage to date around this collaboration. Anyway, ADYOR!