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Introduction

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

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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.