How do I test a randomisation system?

When your randomisation system is set up in Sealed Envelope’s staging environment, you should test it until you are satisfied it meets your requirements and is randomising as expected.

The test system is an identical copy of the live randomisation system except it will use a dummy randomisation list or code list (where appropriate). To test it, we recommend taking the following steps:

1. Add at least one site
2. Check the specification page and make sure it matches your requirements
3. Check the randomisation form. If detailed inclusion and exclusion criteria are listed make sure these are consistent with the approved protocol. If there are validation checks on fields (e.g. an age range on the date of birth field) make sure these operate correctly.
4. Perform some randomisations. Check that these are conforming to the randomisation protocol (blocks, minimisation etc). Ask Sealed Envelope for the dummy list or code list if necessary to help you check this. You may find the statistician for your trial can help, particularly if you have strata or are using minimisation.
5. Create an investigator role and try randomising. This will show you the simplified interface investigators see.
6. If relevant, create a blinded role (or other bespoke roles as required for your trial) by editing the user permissions and check that it behaves as expected.
7. Check you have received the email notifications for the randomisations. Make sure they contain the correct information.
8. Try marking a randomisation as in error. Check the reports now exclude this record.
9. If relevant, try unblinding a randomisation. Check the treatment group matches the dummy code list.
10. Try downloading the randomisations as a CSV file. Check the data is consistent with the randomisations you have performed.