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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 | |
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 |
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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. |
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h2. Define structured eligibility criteria CDE
|| *Use Case Number* \\ | Init1dbw7.pm19.1\\ |
|| *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* \\
The state of the system before the user interacts with it \\ | None.\\ |
|| *Post condition* \\
The state of the system after the user interacts with it \\ | A structured eligibility criteria is encoded in a CDE.\\ |
|V *Steps to take* \\
The step-by-step description of how users will interact with the system to achieve a specific business goal or function \\ | # The Metadata Specialist creates a CDE to be used as structured eligibility criteria.
# The Metadata Specialist adds the concepts that describe the data to be evaluated (e.g. age)
# The Metadata Specialist adds the operator (e.g. greater-than or equals)
# The Metadata Specialist adds the data to evaluate against (e.g. 30) |
|| *Alternate Flow* \\
Things which would prevent the normal flow of the use case \\ | 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* \\
The priority of implementing the use case: *High, Medium or Low* \\ | Medium.\\ |
|| *Associated Links* \\
The brief user stories, each describing the user interacts with the system for the one function only of the use case. There would potentially be a number of user stories that make up the use case. \\ | * [Init1dbw7 - Structured Eligibility Criteria|https://wiki.nci.nih.gov/x/mw1yAQ] |
|| *Fit criterion/Acceptance Criterion* \\
How would actor describe the acceptable usage scenarios for the software or service that meets the actor's requirement? \\ | Additional requirements need to be gathered to determine the range of operations and rules that can be encoded in structured eligibility criteria.\\ |
h2. Evaluate structured eligibility criteria
|| *Use Case Number* \\ | Init1dbw7.pm19.2\\ |
|| *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* \\
The state of the system before the user interacts with it \\ | A form of structured eligibility criteria is available.\\ |
|| *Post condition* \\
The state of the system after the user interacts with it \\ | Each eligibility criteria is evaluated against source data.\\ |
|| *Steps to take* \\
The step-by-step description of how users will interact with the system to achieve a specific business goal or function \\ | # The Cancer Researcher inputs data for each structured eligibility criteria CDE.
# The Cancer Researcher requests to have the data evaluated for eligibility.
# The service evaluates each piece of data against each referenced structured eligibility criteria by applying the correct operator and evaluation data.
# The service returns the eligibility results to the Cancer Researcher. |
|| *Alternate Flow* \\
Things which would prevent the normal flow of the use case \\ | None.\\ |
| *Priority* \\
The priority of implementing the use case: *High, Medium or Low* \\ | Low.\\ |
|| *Associated Links* \\
The brief user stories, each describing the user interacts with the system for the one function only of the use case. There would potentially be a number of user stories that make up the use case. \\ | * [Init1dbw7 - Structured Eligibility Criteria|https://wiki.nci.nih.gov/x/mw1yAQ] |
|| *Fit criterion/Acceptance Criterion* \\
How would actor describe the acceptable usage scenarios for the software or service that meets the actor's requirement? \\ | It is highly desirable that the results of each eligibility criteria is returned, but minimally the overall results (eligible or not) should be returned.\\ |
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