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


Project Leads

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

Scott Getzin (Lilly) –

Ed Helton (NCI) –

Tracy Beck (Lilly) -

Sarah Larson (Genzyme) -


Project Working Documents

Active Working Documents are stored on GFORGE:

CTRR - GFORGE Location

Other CTRR Historical Documents:

CTRR Working Documents


Project Team Participation

How to Get Connected


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


HL7 CTRR Ballot Reconciliation for May 2010

RCRIM Approved Ballot Reconciliation Results


HL7 Voting Introduction



Other HL7 Educational Materials

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


Project Testing Page

CTRR Testing Page


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!!