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