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Introduction
Any decision node activity has some criteria check
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and most randomization 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 eligibility.
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.
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If the
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test would have been run several times, you
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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
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, however the Principal Investigator considers that the subject should
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pass...
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Graphic Study Flow
The graphic study flow indicates the theoretical possible pathways corresponding to the protocol and highlights the subject specific pathway. The difference in colors of the activities indicate the status of the activity.
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