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.