Randomisation

Q. When the unblinded researcher has confirmed that the randomised treatment has been completed will they need to log back into Sealed Envelope to confirm this?

A. Yes, the unblinded person will have to log back on to complete the eligibility and intervention data, once intervention has been completed. Both are simple forms to complete and will be demonstrated at the site initiation.

Q. Should the email that the unblinded researcher receives to confirm the randomisation allocation be retained anywhere as a hard copy for eventual archiving?

A. There is no requirement to print out the email. During randomisation a form is completed on the database and this is saved if access is required at a later date. It is best practice not to print the email out in case it accidentally unblinds someone.

Q. Will the randomisation process auto-generate an email to the other site staff to confirm that a patient has been randomised?

A. Yes there will be an email to the blinded staff to confirm that a patient has been randomised but it will not include the treatment allocation.

Q. If there was a problem with the first patient and the blinded researcher needed to assist, could they still consent and follow up that patient? 

A. This is a simple straight forward trial and this would be unlikely to happen. As the devices look the same it would be unlikely that unblinding would take place. However it is advised that the blinded nurse should avoid any follow up or data collection for that particular patient if possible.