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Introduction

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

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Running an Eligibility Test

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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

The criteria check might have the result 'failed', but that does not necessarily mean ineligibility or some failure. 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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 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.

Test Passed

If the test passed, you could randomize your subject or would need to confirm the proposed allocated arm if it is a decision node.