Clinical Trials Registration and Results

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Clinical Trials Registration and Results - WIKI page

The intent of this page is to have a repository of documents or artifacts associated with the Clinical Trials Registration and Results project.

Project Scope

This document was amended and approved by RCRIM on November 25, 2008

CTR&R Project Scope

Approved Project Charter on January 21, 2009:

Project Charter Version 1.0

Presentation from the December 10, 2008 - Public Meeting:

Public Meeting Presentation

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Project Leads

If you have any issues or concerns, please contact one of the following:

Ed Helton (NCI) – heltone2@mail.nih.gov

Tracy Beck (Lilly) - becktj@lilly.com

Kristofer Spahr (Wyeth) - spahrk@wyeth.com

Scott Getzin (Lilly) – sgetzin@lilly.com

Mitra Rocca (Novartis) – mitra.rocca@novartis.com

Project Meeting Minutes

CTRR Meeting Minutes

Project Working Documents

CTRR Working Documents

Project Team Participation

How to Get Connected

Overall Project Timeline (subject to change)

May 2009 – Message Development

• Complete Storyboards, Interaction and Activity Diagrams, Trigger Events, etc...
• Develop CTRR HL7 Models based on existing artifacts

September 2009 – Ballot

• Informational level only (providing Storyboards, Interaction and Activity Diagrams, Trigger Events)

January 2010 – Ballot

• DSTU Ballot - Draft Standard for Trial Use (providing all ballot materials including the model)

February 2010 - Begin Testing (likely period - 6 to 12 months)

• Develop Implementation Guide based on Testing

January 2011 – Ballot

• Normative Ballot (providing all ballot materials including the implementation guide)

February 2011 - Begin Implementation and Production Use!!