Edinburgh Clinical Trials

Randomisation Service

We can provide a standalone web-based randomisation service, or a randomisation service built into the bespoke data management system. The service can be programmed to use stratified block randomisation or minimisation.

The service 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. The system can automatically generate confirmation emails and send them to relevant personnel in the study team. Researchers can be kept blinded to treatment allocation as appropriate.

Multiple stratification or minimisation factors may be programmed into the system. The system can be programmed to perform validation checks - such as checking for duplicate Participant Numbers, or entered data which would render the participant ineligible for the study (for example a date of birth that makes them outside an age band stipulated in the eligibility criteria) - and prevent 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.

We are happy to discuss the specific randomisation requirements for your study with you.


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Data and IT Systems Manager

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