Define structured eligibility criteria CDE
Use Case Number |
Init1dbw7.pm19.1 |
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Brief Description |
Structured eligibility criteria allows for data to be evaluated against standard criteria in the form of a CDE to determine eligibility to a clinical trial. For example, the eligibility criteria may be that the subject must be male and the structured criteria would be gender equals male. This can be represented as a CDE with an operator and value, e.g. age >= 21. |
Actor(s) for this particular use case |
Metadata Specialist |
Pre-condition |
None. |
Post condition |
A structured eligibility criteria is encoded in a CDE. |
V Steps to take |
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Alternate Flow |
A wide variety of structured eligibility criteria can exist that ranges from mathematical operations to boolean operations to even more complex ternary and beyond operations. |
Priority |
Medium. |
Associated Links |
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Fit criterion/Acceptance Criterion |
Additional requirements need to be gathered to determine the range of operations and rules that can be encoded in structured eligibility criteria. |
Evaluate structured eligibility criteria
Use Case Number |
Init1dbw7.pm19.2 |
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Brief Description |
Once a set of structured eligibility criteria are encoded, a service should be able to evaluate that criteria against matching data. The data points themselves should reference the structured eligibility criteria CDE to which they refer. |
Actor(s) for this particular use case |
Cancer Researcher |
Pre-condition |
A form of structured eligibility criteria is available. |
Post condition |
Each eligibility criteria is evaluated against source data. |
Steps to take |
|
Alternate Flow |
None. |
Priority |
Low. |
Associated Links |
|
Fit criterion/Acceptance Criterion |
It is highly desirable that the results of each eligibility criteria is returned, but minimally the overall results (eligible or not) should be returned. |