/ RANDOMISATION SERVICE REQUEST FORM / WPD 15.1

Please consult with a trial statistician before completing this form.

1  Nominated Persons and date of request

Nominated persons are trial members who the NCTU are to accept service related requests from:

Name / Main Contact (please mark)
Chief Investigator: / Click here to enter text. / ☐
Trial Statistician: / Click here to enter text. / ☐
Trial Manager/Coordinator: / Click here to enter text. / ☐
Date of Request: / Click here to enter text. / Click here to enter a date.
If form not completed by the trial statistician, please tick to confirm it has been approved by a statistician / ☐
2  Contact Details of Main Contact
Email Address: / Click here to enter text.
Telephone Number: / Click here to enter text.
Employer’s Organisation: / Click here to enter text.
3  Randomisation Details
Full title of trial: / Click here to enter text.
Trial acronym: / Click here to enter text.
Trial Sponsor: / Click here to enter text.
Trial Funder: / Click here to enter text.
Is the trial a PhD project? / Yes / ☐ / No / ☐
If yes, what is the funding source? / University of Nottingham or external studentship / ☐ / External Fellowship / ☐
Part of a larger project / ☐ / Other / ☐
If other, specify Click here to enter text.
Trial duration: / Expected date of 1st randomisation: / Click here to enter a date. / Estimated Last Patient Last Visit: / Click here to enter a date.
Single or Multi-Centre: / Single / ☐ / Multi / ☐
If Multi, number of sites
____
Design of trial: / Parallel Group / ☐ / Factorial / ☐
Cross Over / ☐ / Other (specify) / ☐ Click here to enter text.
What is the unit of randomisation
e.g. participant, site, GP practice, hospital / Click here to enter text.
Randomisation method
(tick one only): / Blocked only / ☐ / Minimised only / ☐
Stratified + blocked / ☐ / Stratified + minimised / ☐
Will the block size be randomly varied?
(tick one only): / Yes / ☐
No / ☐ / If No, specify block size Click here to enter text.
Names/Numbers per trial arm / Name / Target Number to be randomised (please allow for potential drop outs)
Arm 1: / Click here to enter text. / Click here to enter text.
Arm 2: / Click here to enter text. / Click here to enter text.
Arm 3: / Click here to enter text. / Click here to enter text.
Arm 4: / Click here to enter text. / Click here to enter text.
Arm 5: / Click here to enter text. / Click here to enter text.
Arm 6: / Click here to enter text. / Click here to enter text.
Is this a CTIMP trial (i.e. a clinical trial of an Investigational Medicinal Product)? / Yes / ☐ / No / ☐
If Yes, please name all IMPs: / Click here to enter text.
If Yes, is a trial prescription to be generated by the system? / Yes / ☐ / No / ☐
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: / Click here to enter text.
Inclusion and Exclusion criteria for units of randomisation as described in the trial protocol or grant proposal (whichever document is most recent): / Click here to enter text.
List any checks to be performed by the randomisation service prior to randomisation:
E.g. participant ≥18 / Click here to enter text.
Fuller details and definitions of randomisation (stratification and/or minimisation) variable: / Click here to enter text.
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: / Click here to enter text.
4  Stratification/Minimisation Factors
Please provide details about stratification
Stratification Factor Type / Number of Categories / Details of Categories
Click here to enter text. / Click here to enter text. / Click here to enter text.
Click here to enter text. / Click here to enter text. / Click here to enter text.
SOP 15_Randomisation Service Request_Final version 1.1 05-Jul-2016
Effective date: 19-Jul-2016 / Page 5 of 6
/ RANDOMISATION SERVICE REQUEST FORM / WPD 15.1
Minimisation Factor / Number of Categories / Details of Categories
Click here to enter text. / Click here to enter text. / Click here to enter text.
Click here to enter text. / Click here to enter text. / Click here to enter text.
Click here to enter text. / Click here to enter text. / Click here to enter text.
SOP 15_Randomisation Service Request_Final version 1.1 05-Jul-2016
Effective date: 19-Jul-2016 / Page 5 of 6
/ RANDOMISATION SERVICE REQUEST FORM / WPD 15.1

5  Randomisation Database Access and Notifications

Names and details of trial staff that will require access to the randomisation system/permissions to perform randomisation (typically trial recruiting centre staff or staff at the trial coordinating centre) or who will need to receive e-mails confirmations of randomisations performed.

Name / Centre / Role / E-mail address / Allowed to randomise / Requires access to rando system / Blinded / Receive confirmation
of rando
e-mails
Tick if required / Tick if required / Tick if blinded / Tick if required
Click here to enter text. / Click here to enter text. / Click here to enter text. / Click here to enter text. / o / o / o / o
Click here to enter text. / Click here to enter text. / Click here to enter text. / Click here to enter text. / o / o / o / o
Click here to enter text. / Click here to enter text. / Click here to enter text. / Click here to enter text. / o / o / o / o
Click here to enter text. / Click here to enter text. / Click here to enter text. / Click here to enter text. / o / o / o / o
Click here to enter text. / Click here to enter text. / Click here to enter text. / Click here to enter text. / o / o / o / o
Click here to enter text. / Click here to enter text. / Click here to enter text. / Click here to enter text. / o / o / o / o
Click here to enter text. / Click here to enter text. / Click here to enter text. / Click here to enter text. / o / o / o / o
Click here to enter text. / Click here to enter text. / Click here to enter text. / Click here to enter text. / o / o / o / o
Click here to enter text. / Click here to enter text. / Click here to enter text. / Click here to enter text. / o / o / o / o
Click here to enter text. / Click here to enter text. / Click here to enter text. / Click here to enter text. / o / o / o / o
Click here to enter text. / Click here to enter text. / Click here to enter text. / Click here to enter text. / o / o / o / o

6  Trial Sites and PI Names

Principle Investigator Name / Centre/Site Name
Click here to enter text. / Click here to enter text.
Click here to enter text. / Click here to enter text.
Click here to enter text. / Click here to enter text.
Click here to enter text. / Click here to enter text.
Click here to enter text. / Click here to enter text.
Click here to enter text. / Click here to enter text.

7  Any other relevant information:

Click here to enter text.

8  Sign off/approval by requester:

Signature:
Print Name:
Date:
SOP 15_Randomisation Service Request_Final version 1.1 05-Jul-2016
Effective date: 19-Jul-2016 / Page 5 of 6