Init1pm13 - Medidata

Date: 

12/17/2009

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

Init1pm13

Originator/Customer's Name:

Christo Andonyadis

Originator/Customer's Company:

NCI

Summary of requirement pre-interview, by Reviewer:

Medidata is the clinical trials database selected by NCI for use at trial sites.  Medidata supports the import and creation of forms by Forms Authors based on common data elements.  Associated with this are likely to be a number of use cases on the functionality that Medidata needs for querying and importing CDEs and forms.  See attachments for additional information.

• NCI Use Case Review_ Labs 20091211.ppt
• NCI HLR Review All 20091209.ppt
• medidata_notes_20081211.doc
  One of the requirements currently not met is the need to be able to specify that a CDE on a form can have multiple answers selected from the enumerated value list.   Currently this is captured in the Question Instruction of the Form objects.  Users would like to be able to specify this for the CDE.  one approach is to create a Derived Data Element composed of the number of CDEs that are permitted in the response.  this can be supported in the current 11179 Ed 2 metamodel.
  Furthermore, it appears that what is needed is a collection of metadata "things" - forms, CDEs, etc. that are named and have privileges.  There are some in global scope (managed by a certain few people), a user can create any number of them, and that user can make his publicly available (say, give me John's public collections, then give me John's Breast Stdy 123 collection).  There would be a service (API) with these types of functions.

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

Use Case Development (2/3/2010) Assigned to Mohamed

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