Init1dbw3 - HL7 MDR Requirements (CIC Input)

Date: 

12/09/2009

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

Init1dbw3

Originator/Customer's Name:

CBIIT - Margaret Haber                                                                                        

Originator/Customer's Company:

HL7 draft CIC MDR requirements

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).

SDO

Summary of requirement pre-interview, by Reviewer:

Support for interoperability between groups with MDRs; Collaboration tools for reviewing similar standards and making refinements to final standard; User friendly Browser; Easy way to create data elements from line of business artifacts such as a spreadsheet or database description; Need to have private and public content in the MDR;

Requirements include functional and non-functional (would like to be involved in the requirements process, UI design/feedback sessions for browsers, etc.)

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

Review document, schedule interview/questionnaire when Init 1 resources are on board (full time project Business Analysts)