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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

  1. The Metadata Specialist creates a CDE to be used as structured eligibility criteria.
  2. The Metadata Specialist adds the concepts that describe the data to be evaluated (e.g. age)
  3. The Metadata Specialist adds the operator (e.g. greater-than or equals)
  4. 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.
V

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.

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.

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