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