Init1dbw7 - Structured Eligibility Criteria

Date: 

12/28/2009

Requirement # unique id <SemCon Ops Initiative>.<analysts initials><requirement number>
e.g. Init1dbw1
(eventually linked to Use Cases)

Structured Eligibility Criteria (SEC)

Originator/Customer's Name:

Christo Andonyadis, with input from Charlie Mead and David Hau                                                                                        

Originator/Customer's Company:

CBIIT

Summary of requirement initial analysis, by Reviewer:

-->The structured eligibility criteria (SEC) use case supports eligibility screening - that is, matching eligible patients for protocols and vice versa, based on a predetermined set of criteria.

It looks like we'll need to support at a minimum:

1.  CDE lookup based on SEC - A protocol designer will need to be able to build and validate the SEC based on programmatic retreival of CDE metadata. 
2.  Forms (CDA) capability -SECs will be represented in CDA format, so a protocol designer will need to be able to create, store, retrieve and manage the lifecycle of CDA templates based on CDEs.
There may be additional requirements on the model and rule repositories and services to determine reason about eligibility based on using rules about the CDEs containing the patient + protocol data e.g. Patient must be 30 years old at time of registration --> would need to compare the CDE containing this patient information with the rule that they must be over 30 years old.

Recommended Next StepEnter one: Follow-up interview, Observe, Use Case Template (text), Use Case Model (formalized/UML diagram), Group Discussion, Prototype, Waiting Room

Interview or group discussion to develop use case scenarios

Stakeholder Community:

Enter appropriate category of stakeholder from Primary Stakeholders:  

• Software and Application designers and architects
• Software and Application engineers and developers
• Scientific and medical researchers
• Medical research protocol designers
• Clinical and scientific research data and metadata managers
• Clinicians
• Patients
• Medical research study participants
• Broader Stakeholders: caBIG® Community WS NIH projects and related commercial COTS vendors (caEHR, SDO's (HL7, CDISC); International Collaborators (e.g NCRI, cancerGrid, China), Government and regulatory bodies (FDA, CDC, ONC)
  (link to view SemConOps Stakeholders description).
  

Requirement Type (required)

Analyst's assessement of the most appropriate category/type of requirement (no need to ask interviewee):

• Functional: Fundamental or essential to the product - describes what the product has to do or what processing is needed
  
• Nonfunctional: properties the functions must have such as performance, usability, training or documentation
  
  • Project constraint: schedule or budget constraints
    
  • Design constraint: impose restrictions on how the product must be designed, such as conformant to ISO 11179, utilizes 21090 or is able to work on a particular type of device
    
  • Project driver: business-related forces such as descriptions of stakeholders or purpose of the product/project
    
  • Project issue: conditions that will contribute to the success or failure of the project

ConOp Initiative(s)
Requirements Analyst/Business Analyst

• Select most appropriate initiative: (click for descriptions) 
• Initiative 1 - Distributed, federated metadata repositories and model repositories and operations
• Initiative 2 - Automated generation of metadata from line-of-business artifacts
• Initiative 3 - Rules management and contracts support (behavioral semantics)
• Initiative 4 - Semantics support for W3C service oriented architecture resources
• Initiative 5 - HL7 CTS II/ OMG MIF compliant federated terminology services
• Initiative 6 - Controlled biomedical terminology, ontology and metadata content
• Initiative 7 - Assessment of semantic unification of compositional and derivational models
• Initiative 8 - Other

High Level Use Case Summary)
Requirements Analyst/Business Analyst

Please write a short descriptive narrative use case; the steps or activities in this use case are usually the things the user wants to accomplish with the system (user/actor's goals).  

Use Case Linkage (required)
Business Analyst

Which use case(s) is this requirement linked to?  (should follow Use Case numbering scheme <SemCon Ops Initiative>.<analysts initials><requirement number>.<use case number>, for example Init1dbw1.1, Init1dbw1.2, Init2dbw2.1, 2.2, etc.

Use case Number(s):

Conflicts / Dependencies(required)
Requirements Analyst/ Business Analyst

Are there any conflicts with other requirements / use cases? 

Yes OR No - If yes, what and why?

Next Step (required)
(Requirement Analyst / Business Analyst)

After reviewing the results of the interview, the forum, and all other materials related to this requirement, the analyst should recommend the next step, then attach the Tiny Link (on the Info tab) for this page to the Master List table.

Enter one: Follow-up interview, Observe, Use Case Template (text), Use Case Model (formalized/UML diagram), Group Discussion, Prototype, Waiting Room