Please consult with a trial statistician before completing this form.
1Nominated Persons
Nominated persons are Trial members who the NCTU are to accept service related requests from:
Name / Main Contact (please mark)
Chief Investigator: /
Trial Statistician: /
Trial Manager/Coordinator: /
If form not completed by the trial statistician, please tick to confirm it has been approved by a statistician /
2Contact Details of Main Contact
Email Address:
Telephone Number:
Employer’s Organisation:
3Randomisation Details
Full title of trial:
Trial acronym:
Trial Sponsor:
Trial Funder:
Is the trial a PhD project? / No / / Yes /
If yes, what is the funding source? / University of Nottingham or external studentship / / External Fellowship /
Part of a larger project / / Other /
If other, specify______
Trial duration: / Expected date of 1st randomisation: / __ __/______/ ______/ Estimated Last Patient Last Visit: / __ __/______/ ______
Single or Multi-Centre: / Single / / Multi /
If Multi, number of sites ____
____
Design of trial: / Parallel Group / / Factorial /
Cross Over / / Other (specify) / ______
What is the unit of randomisation
e.g. participant, site, GP practice, hospital / ______
Randomisation method
(tick one only): / Blocked only / / Minimised only /
Stratified + blocked / / Stratified + minimised /
Will the block size be randomly varied?
(tick one only): / Yes / / If yes, specify all block sizes ______
No / / If No, specify block size _____
Names/Numbers per trial arm / Name / Target Number to be randomised (please allow for potential drop outs)
Arm 1:
Arm 2:
Arm 3:
Arm 4:
Arm 5:
Arm 6:
Is this a CTIMP trial (i.e. a clinical trial of an Investigational Medicinal Product)? / No / / Yes /
If Yes, please name all IMPs: / ______
If Yes, is a trial prescription to be generated by the system? / No / / Yes /
Randomisation as described in the trial protocol or grant proposal (whichever document is most recent). Please include any information that also relates to sample size:
Inclusion and Exclusion criteria for units of randomisation as described in the trial protocol or grant proposal (whichever document is most recent):
List any checks to be performed by the randomisation service prior to randomisation:
E.g. participant ≥18
Fuller details and definitions of randomisation (stratification and/or minimisation) variable:
Emergency unblinding procedure (as per trial protocol). Please state who will be doing this or if the randomisation system is required to provide this facility:
4Stratification/Minimisation Factors
Please provide details about stratification
Stratification Factor Type / Number of Categories / Details of Categories
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/ Nottingham Clinical Trials Unit Randomisation Service Request FormMinimisation Factor / Number of Categories / Details of Categories
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/ Nottingham Clinical Trials Unit Randomisation Service Request Form5User Access Accounts Required
Names and details of trial staff who will require access to the randomisation system/permissions to perform randomisation (typically trial recruiting centre staff or staff at the trial coordinating centre).
Site(s) user needs access to / Name / Role / E-mail address / Blinded?(tick if blinded)
E.g. Nottingham / Joe Bloggs / Admin Assistant / / ☒
E.g. All / Anne Smith / Trial Coordinator / / ☐
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6Automated Confirmation of Randomisation Emails
Site(s) / Name / E-mail address / Blinded?(tick if blinded)
E.g. Nottingham, Derby / Joe Bloggs / / ☒
E.g. All / Anne Smith / / ☐
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Names and details of recipients who will who will need to receive confirmations of randomisation e-mails.
7Trial Sites and PI Names
Principle Investigator Name / Centre/Site Name8Any other relevant information:
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