Introduction

Any decision node activity has some criteria check and most randomization activities will also have some criteria check. Such criteria checks are called an eligibility test, although not all these criteria checks are necessarily checks of protocol eligibilityEach 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.

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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.

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