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Pre Interview:
Item | Information/Response |
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Date: | 01/13/2010 |
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Requirement # unique id <SemCon Ops Initiative>.<analysts |
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initials><requirement |
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number> |
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|
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Init1dbw1 |
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| Init3SD1 |
Originator/Customer's |
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Name |
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: |
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Hannes |
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Neidner |
Originator/Customer's |
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Company |
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: |
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San |
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Diego |
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Supercomputer |
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Center |
Summary of requirement pre-interview, |
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by |
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Reviewer: |
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Due |
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to |
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the |
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plethora |
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of |
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legal, |
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regulatory, |
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policy,proprietary, |
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and |
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contractual |
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barriers |
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to |
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data |
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exchange |
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in |
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caBIG, |
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the |
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set |
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of |
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guidelines |
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that |
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define |
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compliance |
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to |
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caBIG |
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should |
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reflect |
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the |
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regulatory |
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framework |
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under |
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which |
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the |
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data |
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exchange |
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would |
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happen |
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so |
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that |
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it |
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creates |
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a |
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synergy |
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amongst |
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all |
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regulatory |
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and |
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compliance |
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obligations. | |
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 |
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\\ \\
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 |
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