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Pre Interview:

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Item

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Information/Response

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Date: 

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h2. Pre Interview:

|| Item || Information/Response ||
| {color:#000000}{*}Date{*}{color}{color:#000000}: {color} | 12/17/2009

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| {color:#000000}{*}Requirement # unique id{*}{color} _<SemCon Ops Initiative>.<analysts initials><requirement number>

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e.g. Init1dbw1

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Init1pm13

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(eventually&nbsp;linked to Use Cases) | Init1pm13 \\ |
| *Originator/Customer's Name*:

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 | Christo

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 Andonyadis \\ |
| *Originator/Customer's Company*:

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NCI

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 | NCI \\ |
| *Summary of requirement pre-interview, by Reviewer:

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* | Medidata is the clinical trials database selected by NCI for use at trial sites.

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&nbsp; Medidata supports the import and creation of forms by Forms Authors based on common data elements.

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&nbsp; 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.

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&nbsp; See attachments for additional information.

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* [^NCI Use Case Review_ Labs 20091211.ppt

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* [^NCI HLR  Review All 20091209.ppt

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* [^medidata_notes_20081211.doc

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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.

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

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&nbsp;&nbsp; Currently this is captured in the Question   Instruction of the Form objects.&nbsp; Users would like to be able to specify   this for the CDE.&nbsp; one approach is to create a Derived Data Element   composed of the number of CDEs that are permitted in the response.&nbsp; 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.&nbsp; 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).&nbsp; 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

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 Mohamed \\ |
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