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Difference between revisions of "Clinical Trials Registration and Results"

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[http://wiki.hl7.org/images/b/b3/DIA_Annual_-_Getzin_Scott_Clinical_Trial_Registration_and_Results_Project_Update_and_Future_Use_Case.zip DIA Annual Meeting]
 
[http://wiki.hl7.org/images/b/b3/DIA_Annual_-_Getzin_Scott_Clinical_Trial_Registration_and_Results_Project_Update_and_Future_Use_Case.zip DIA Annual Meeting]
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Project from the September 14, 2011 - DIA - CT Disclosure Meeting:
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[http://wiki.hl7.org/images/0/08/DIA_Sept_2011-_Getzin_-_Clinical_Trial_Registration_and_Results_Project_Update.pptx DIA CT Disclosure Meeting]
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Revision as of 15:40, 27 October 2011

Return to RCRIM main page

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 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 - May 2010

  • 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

or

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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!!