Randomisation

The KCTU manages a bespoke online randomisation system, supporting:

simple randomisation

Randomization without restriction. In a two-group trial, it is analogous to the toss of a coin.

block randomisation

stratified block randomisation

minimisation

Find out more

To find out more about the KCTU Randomisation services, preview/download
this flyer.

To request a Randomisation Data Extract, please download this form.

 

The system is online and can be accessed 24 hours a day. Researchers within the study team log in, enter key information about the participant, and the randomisation allocation occurs instantly. Confirmation emails are generated automatically and sent to relevant personnel in the study team.

Researchers can be assigned the ability to randomise participants or they can be assigned an observer role, where they are copied into randomisation confirmation emails. All researchers, whether randomisers or observers can be kept blind to treatment allocation where appropriate, with pharmacists or therapists receiving confirmation emails with treatment allocation information. Multiple stratification or minimisation factors may be programmed into the system. Test data is generated before the study begins, to check balance across stratification factors. The system can be programmed to perform validation checks, such as checking for duplicate Participant Identification Numbers and preventing randomisation from proceeding in such cases.

In medicinal trials, the active and placebo unique treatment pack numbers, batch numbers and expiry dates can be programmed into the system, with the system recording packs delivered to specific site pharmacies and only allocating medication packs that are available in that site to participants randomised there. The system can also be programmed to generate a schedule of each participants visit timeline for the entire study, to be sent within the randomisation email. A standard feature of all service levels is the ability to download automatically generated recruitment graphs of overall recruitment against target recruitment.

The randomisation system generates confirmation emails that can be blind or unblind to treatment allocation. In the event a specific study requires additional complexity in terms of email confirmation content, this would be a bespoke service and this will require discussion to develop a quote.

Package Costs

The cost calculation of the randomisation service is based on the sample size and the complexity of the study teams requirements.

Bronze service

Sample size x £6.50
Minimum charge £650
Maximum charge £1,030
Two users (randomisers or observers)

  • 1 blinded email confirmation (to outcome assessor)
  • 1 unblinded email confirmation (to therapist/pharmacist)
  • No visit window schedule
  • No link to medicinal treatment pack numbers
  • 1 dichotomous stratification factor allowed

Silver service

Sample size x £8.00
Minimum charge £800
Maximum charge £1,545
Up to ten randomisers or observers
Up to five study sites

  • Site specific blinded email confirmations (to outcome assessors)
  • Site specific unblinded email confirmations (to therapists/pharmacists)
  • No visit window schedule
  • No link to medicinal treatment pack numbers
  • 3 dichotomous stratification factors allowed

Gold service

Sample size x £11.00
Minimum charge £1,100
Maximum charge £2,575
Up to twenty randomisers or observers
Up to ten study sites

  • Site specific blinded email confirmations (to outcome assessors)
  • Site specific unblinded email confirmations (to therapists/pharmacists)
  • Schedule of patient visits generated at randomisation
  • No link to medicinal treatment pack numbers
  • Unlimited stratification factors allowed

Platinum service

Sample size x £16.00
Minimum charge £1,600
Maximum charge £5,150
Unlimited requestors
Unlimited number of study sites

  • Site specific blinded email confirmations (to outcome assessors)
  • Site specific unblinded email confirmations (to therapists/pharmacists)
  • Schedule of patient visits generated at randomisation
  • Unlimited stratification factors
  • Blinded treatment pack numbers
  • Alerts when blinded medication supplies run low