Latest news:
We have received the REC favourable opinion and HRA & HRCW approvals for the substantial protocol amendment.
The amendment package with all the relevant documents have been sent to all participating sites to review. Sites have 35 days from receipt of the amendment notification to raise an objection about the amendment. If we do not hear from you by 10
th September 2018, we will assume that the amendment may be implemented at your site. 
All the documents for the latest substantial amendment can be found under the ‘Adult Registry’ section of our website.

REC approval for the Chief Investigator change and study extension to June 2018 was obtained. All documents for this change are available under our Research Management System's file repository. They can also be accessed

If you have not done so yet, please fill all your team's details on our Research Management System as soon as possible. We need this information to facilitate the operations of the Registry and enable communications to the relevant staff at your site'

If you are still waiting for access to our data entry database, please contact us as soon as possible at


We now have a new data entry database. Any local centre staff who require access to this database, please contact us as soon as possible. We will send you all the necessary instructions required for using this database. Our old database using MDSAS is only open for some time only for you to check your records. NO data should be entered in this database.


Please note that we are currently undergoing an REC amendment for a change of Chief Investigator. Dr Dan Hart is taking over this role from Dr Provan who will still remain as co-investigator. In the same amendment we have notified the REC that we wish to extend the study duration and have sent all our documents for amendment.
The REC has also provided us with the following from the ‘After ethical review – guidance for sponsors and investigators’:

2.1 The favourable ethical opinion of the REC for a specific research study applies for the duration of the study, except where action is taken to suspend or terminate the opinion, subject to approved substantial amendments. Where the duration of the study is to be extended beyond the period specified in the application form, there is no need to notify or seek approval from the REC.

Once we receive our documents back from the REC we will circulate them to all our centres.

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