Init3SD1_Formal representation of policies and regulations

Date: 

01/13/2010

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

Init3SD1

Originator/Customer's Name:

Hannes Neidner                                                                                  

Originator/Customer's Company:

San Diego Supercomputer Center

Summary of requirement pre-interview, by Reviewer:

Due to the plethora of legal, regulatory, policy,proprietary, and contractual barriers to data exchange in caBIG, the set of guidelines that define compliance to caBIG should reflect the regulatory framework under which the data exchange would happen so that it creates a synergy amongst all regulatory and compliance obligations.

Primary actor is clinical researcher who wants to make sure that while he doing research and collaborating with others still complies to all regulatory requirement.

The business goal is to make regulatory compliance simple and computable.
1) There needs to be a computable representation of all regulatory requirement (legal, regulatory, policy,proprietary, and contractual ) that can be plugged into the application design process and consumed by caBIG applications/services.

2) caBIG should make it a priority to unify and simplify the regulatory and legal context of clinical research

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

Interview

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. 

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