Information for researchers
Please find below the relevant trial documents.
Invitation to study and consent forms
(Password protected access files unless indicated as an ‘open access’ file)
Patient information sheet (open access)
Patient consent form (open access)
Carer information sheet (open access)
Carer consent form (open access)
Legal representative information sheet (open access)
Legal representative consent form (open access)
Pregnant partner information sheet and consent form
GP Letter
Invitation to study letter
Leaflet
CRF Screening visit
CRF Baseline visit
CRF Safety Monitoring visit
CRF 6 week assessment visit
CRF 12 week assessment visit
CRF follow-up visit
CRF Unscheduled visit
CRF Adverse event Log
CRF Randomisation form
CRF Withdrawal form
Randomising patients and entering data
You will be given access rights and log-in details to access Sealed Envelope which is the online database and randomisation system for TOP HAT. Please access Sealed Envelope.
When entering data please take your time to make sure the data you enter is accurate. If you are unable to log in or have any difficulties please email Olga Zubko, Trial Manager at o.zubko@ucl.ac.uk.