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

Presentation from the June 17, 2010 - DIA Annual Meeting:

DIA Annual Meeting

Project from the September 14, 2011 - DIA - CT Disclosure Meeting:

DIA CT Disclosure Meeting

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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

Sarah Larson (Genzyme) - Sarah.Larson@genzyme.com


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Project Working Documents

Active Working Documents are stored on GFORGE:

CTRR - GFORGE Location

Other CTRR Historical Documents:

CTRR Working Documents

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Project Team Participation

How to Get Connected


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HL7 CTRR Ballot Materials - May 2010 - DSTU

  • The XSD, HDM, JPG and VSD files are contained in the attached zip file
  • Additional HL7 Core Schemas required for the above CTRR schema zip file


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HL7 CTRR Ballot Reconciliation for May 2010

RCRIM Approved Ballot Reconciliation Results

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HL7 Voting Introduction

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Other HL7 Educational Materials

  • Here is a link to an article that explains the HL7 message development process and the artifact naming convention.

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Project Testing Page

CTRR Testing Page

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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)


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

  • Develop Implementation Guide based on Testing


May 2011 – Ballot

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


June 2011 - Begin Implementation and Production Use!!

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