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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 - From project Insight

CTR&R Project Scope - MSWord File

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:

Scott Getzin (Lilly) – sgetzin@lilly.com

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

Tracy Beck (Lilly) - becktj@lilly.com

Kristofer Spahr (Merck) - kristofer_spahr@merck.com

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Project Meeting Minutes

CTRR Meeting Minutes


Project Working Documents

CTRR Working Documents


Project Team Participation

How to Get Connected

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HL7 CTRR Ballot Materials


HL7 Voting Introduction

or

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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


January 2010 – Ballot

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


May 2010 – Ballot

  • DSTU Ballot - Draft Standard for Trial Use (including EMEA requirements)


June 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!!