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


Questionnaires and data collection (password protected)

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

Training slides

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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.