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Introduction
Each randomization activity will allocate some arm (next activity or activities) according to a minimization technique.
Running an Eligibility Test
If you have a decision node activity or a randomization with an eligibility test, you need to complete all data related to that activity before the eligibility test can be run.
Once all data has been completed, you can click the 'Run Eligibility Test' button and that will check the criteria.
Once the eligibility has been checked, the result, 'test passed' or 'test failed' is shown. If you click the 'Show Details' button, it will show the results (passed or failed) for each individual criterion that was checked.
If the test would have been run several times, you are able to look at the different runs. However, the result of the last run prior to proceeding - to the next activity or by randomization of the subject - is the result that will be taken into account for passing or failing the test.
Test Failed
If the test failed, you would need to acknowledge the 'false' arm. This false arm can have other names, depending on the design of your study.
If the eligibility check fails, however the Principal Investigator considers that the subject should pass, then please contact the sponsor and see Protocol Deviations for more information.For randomization activities that also contain an eligibility check, the minimization can only be done if the eligibility check passed.
Perform Minimization
Once the forms/events linked to the randomization activity are completed and, if applicable, the eligibility check has passed, the minimization can be done by pressing the 'Randomize my Subject' button.
After clicking 'Randomize', an arm will be allocated.
The randomization activity will then close automatically and the next activity will be initiated.