Spinnaker Software provides a randomization system to assign patients in clinical trials to treatment groups. The randomization form collects inclusion/exclusion criteria and patient data, then returns a patient ID, treatment assignment, and instructions. It performs basic validation checks and can be customized. Randomization numbers are produced using blocks and can be stratified. The system ensures patients are not assigned to a treatment group twice. Customer data is securely stored and accessible for reporting. Spinnaker aims to offer an adaptable solution to simplify clinical trial management.

1. Date
Randomisation
with Spinnaker
Audrey Shearer 2014

2. Everything we do is about changing the way
people work. We believe in working smarter not
longer. Being adaptable, not rigid. And in keeping
it simple.
Here’s how we do that with randomisation …

3. Example 1
Simple, clear forms adapted to suit your study
Spinnaker Software www.spinnakersoftware.com

4. Example 2
Long version of
randomisation form
Spinnaker Software www.spinnakersoftware.com

5. Data Collection
The randomisation form typically collects 3
types of data
✤ inclusion criteria
✤ exclusion criteria
✤ personal data eg DOB
and returns
✤ patient study ID
✤ drug treatment type blinded e.g. A or B
✤ further instructions
Spinnaker Software www.spinnakersoftware.co01m

6. Data validation
The randomisation form software can perform minor validation checks on your
behalf such as
✤ check initials and DOB combination and warn if there is an existing patient record
with same
✤ check DOB, where age is a criteria, and warn when outside of acceptable range
✤ other minor checks you may need
Spinnaker Software www.spinnakersoftware.com

7. How we randomise
Randomisation numbers produced by Spinnaker can be stratified by
location (site) and one other variable eg presence of infection and are
then randomised by block. You can set the block size. The Spinnaker
Technical Specification has a full explanation of this. If you prefer your
statistician to provide a randomisation schedule we will load this into our
database and use in place of the Spinnaker generated randomisations.
During randomisation we can verify patient DOB and initials against those
pairs existing in the database and warn where there is a match
highlighting that a patient may have already been randomised and
enrolled in the trial. The operator can proceed if they are sure there is no
doubling of data.
Patient codes are matched to the pre-determined treatment according to
the rules of randomisation set out for your trial. When a patient is
randomised they are assigned a treatment pack number from the currently
available stock.
Spinnaker Software www.spinnakersoftware.com

8. Your data
The reports in your trial are often available as downloads through
an “Export to file” button, seen here.
Your data belongs to you and is available when you want.
Spinnaker Software www.spinnakersoftware.com

9. Spinnaker is flexible and we are adaptable, the better to support you
and your team with your trials.
If you are interested in an adaptable approach, in working smarter,
not longer then take a further look at this intuitive management and
recording system for clinical trials

10. Date
Thanks for watching
We have found that people are picking up iPads and
entering data directly into mobile devices because
our software is easy to use and adaptable. Get in
touch if you want to give this a go!
Because I wanted to keep this simple it only covers
the basics. There is so much more I could show you
about Spinnaker. Please call or email
Audrey
audrey@spiral.co.nz +64 21 395316