Introduction

Any decision node activity has some criteria check that 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.

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 subject is eligible, you need to acknowledge the allocated arm to close the activity and proceed to the next. If the subject is ineligible, you need to accept the false arm.

 If the eligibility check fails and the subject would be ineligible, however the Principal Investigator considers that the subject should be eligible...

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.