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Initial Analysis:

Item

Information/Response

Date

12/30/2009

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

Otherdbw2

Originator/Customer's Name:

Christo Andonyadis                                                                                      

Originator/Customer's Company:

CBIIT Clinical Sciences/Clinical Trials

Summary of requirement initial analysis, by Reviewer: (as unambiguously as possible, describe who (List of Actors) is interacting with the system, what the business goal is and how the system might support the actor's ability to acheive their goal)

Information Modelers and Forms Developers need to be able to optimize reuse of existing infrastructure.  Definitions for CDE and the parts of CDEs that make data interoperable; leveraging metadata to perform automated transformations where the value meanings are the same but different tokens were used to store the data, storing those transformations and using them at run-time. COPPA; be able to automatically capture modifications to existing workflows to create new workflows/apps;  forms repository and authoring tools for exchange of forms in standard format

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 models

Interview

Item

Script / Question

Information/Response

1

Hello, my name is NAME. I am calling you today because NCI and caBIG are working toward a new and improved version of the semantic infrastructure to better support integration scenarios.
Our first step was to organize requirements collected over the past year. Your organization has expressed a requirement/need for BRIEF STATEMENT OF USER REQUIREMENT.  This has been identified as potentially a critical component to support application/data and service integration, and we need more information in order to enable us to meet this requirement.
Do you have about 30 minutes to talk about this?

---                                                                                                      

2

What do you do? What are your goals for the next year?  Why are you doing this?

CS Lead Architect

3

In interacting with the caBIG infrastructure, do you have any solution integration needs? If so, what are they? Have you envisioned new ways of interacting with existing or new parts of the semantic  infrastructure?
(prompt to elicit changes/new ways of using the infrastructure)

1. We need a Forms Registry that results in operational CRFs.  This means the form metadata and the CDEs. The forms need to be able to be exchanged in a standard format, that allow reuse to collect semantically unambiguous data on CRFs.  Possible parties that you would exchange these forms with are caBIG, BIGHealth, CDISC and software vendors like Velos or Medidata how have clinical trials management systems that could take in teh forms descirptions and use them and the CDEs to customize their application.

The content of the form needs to be in a standard 'container', we need to lead the industry to adopt standard form, something as lightweight as an XML XForm.
 We need authoring tools to create the CRFs, be able to consume fo the forms and operationalize them to collect data in a CTMS system like Medidata.

2. We will need more enterprise services.  We need services that can be consumed by other applications, where you don't have to do so much work to get the data out (no training, not 'learning' the data model).  Nee to be able to represent the choreography .. the path through the form. 
3. We need workflow engines
4. We need to be able to build applications, shouldn't have to rebuild/annotate the common things. Maximizing reuse of services minimize development of new services  Make it easier to share, applications are too hard to integrate and interoperate.  Better support the "adapt" patter, make it easy to work with other systems.
5. Rules: anyone anywhere should be able to find a service, see the little pieces about a protocol that need to be added or changed in order to reuse the data or service.  Need ot be able to modify systems to include important steps or data.  Need the right set of attributes to describe a protocol, find the state diagram for a protocol and inspect it, reuse it.
6. Security in clinical science is a big issue.  Tools need to allow people to build applications with authorization and authentication.
7.  need services to author authorizations
8. Develop standard "Roles" for accessing content so the security profiles can be reused. An ontology for roles.

4

Are there any business changes you are assuming we will be able to deal with? 
(prompt to elicit changes/new ways of using the infrastructure) 

Yes, a move to ECCF and OA

5

Are there any capabilities you are expecting to be available to support your needs? 
(prompt to elicit expectations/dependencies)

---

6

Do you use any of the existing software/services? If so, what do you like or dislike about it?
(if related to existing capability)

Yes, the caDSR APIs for pulling data our of caDSR are used, but they are not useful enough.  The end user has to know too much about the caDSR data model to get things out.  It needs to be easeir to retrieve whole "Forms" or whole or parts of "Models". 

7

If this requirement is met, what would be the benefits? If you do not have it, what would be the negative impact?
(prompt to elicit benefits/value - will help to prioritize)

Summary of perceived benefit or negative impact

8

If, for any reason, we were not able to create that solution, do you think there might be another way to solve this issue? Can you think of an alternative solution?
(prompt to elicit alternative solutions/workarounds)
(to be prepared by the Requirement Analyst)

Description of any other solution that customer can envision

9

Would you agree that we can summarize your requirement like this?
(Summarize one requirement in 2-3 lines and read back to interviewee for confirmation.)

Requirement statement accepted by interviewee

10

How important is this requirement to the interviewee? Required: Customer Priority/Annotationrement Analyst
(Provides concrete assessment of the relative importance for the requirements specification)

Select:

  1. Must have
  2. Should have
  3. Nice to have but not essential
  4. Other (describe)

11

On a scale from 1 to 3 with 1 being "not satisfied" to 3 "completely satisfied", how would you rate your overall satisfaction with the product if this requirement was met?  (Relative rating/ranking of how satisfied or dissatisfied interviewee would be if this requirement were met/not met)

Select:

  1. Not satisfied
  2. Mostly satisfied
  3. Completely satisfied 
  4. Other (describe)

12

Are there other requirements that you would like to share with us? I'd be more than happy to call you back another time, or if you have another 10 minutes, please share other issues you can think of.
(prompt to elicit any hidden - potentially higher priority requirements if they exist)

(If yes, take notes to use in on a new page with this template; if time not available now, try to make appointment for another call.)

13

Who else should we talk to in order to elicit more information about this need?

Name of contact(s)

 

For specific service enhancement or requirement from Forum entry:

---

14

Can you or someone else give me a step-by-step description of how you would describe the expected performance/behavior of the software in order for you to feel that your requirement is met? 
(Required: Fit Criterion - will help us create test cases and user acceptance criteria - to be prepared by the Requirement Analyst)

Well defined measurable verifiable expectation

15

Forum Link:

VKC or other forum where this requirement is discussed

16

URLs (optional):

Links to pages or applications related to this requirement

17

References (optional):

Links to articles, papers or presentations related to this requirement


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