The system release process
A new system (such as a randomisation or Red Pill application for your trial) undergoes a formal release process to ensure that it meets the agreed specification, has been tested and accepted by you (the customer), and is authorised to go into production. Production (live) systems are identical to test systems with some exceptions, such as using a different randomisation or code list. The same release process is also used when making changes to a production system.
The release process is an important step to show that the system is in a validated state, as required by clinical trial regulations such as Guideline for Good Clinical Practice E6(R2).
Release candidates
For formal sign-off of the system we need you to test a version where the CRF, randomisation specification (where applicable), and any customisations are locked down and unchangeable so that the system version that you test is the same as the version that we make live. To enable this we create release candidate versions when requested, and expect you to carry out your formal acceptance testing against a specific release candidate. Release candidates are denoted by a suffix to the version number (RC1, RC2 etc). For example version 1.0.0-RC3 is the third release candidate of a new system. The version number is shown in the footer on every page of the system.
Randomisation systems
Most randomisation systems are set up by Sealed Envelope, and each test system we give you will be a release candidate version.
Red Pill and self-service systems
If you are configuring the system yourself in the CRF builder then you can create a test system at any time. The test system will use the current revision of the CRF and any randomisation specification and apply any existing customisations we have created for you.
It will not be possible for you to create a test system when existing customisations will be affected by changes to the CRF – in this case please contact us to resolve the problem.
Once you have finished configuring your system and are ready to carry out acceptance testing, please contact us to request a release candidate version. We will add any agreed customisations (or check existing ones) and provide you with a release candidate version.
If you update the CRF in the builder after we've created a release candidate it invalidates that candidate, so we will need to create another one for you.
Customer acceptance
Following successful completion of your testing you will need to ask us for a sign-off form that will authorise us to make the release candidate live – you should allow a day or two from our receipt of the signed form for the system to be made live.