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

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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

• Telecom: 770-657-9270 . Passcode: 745896
• ATT Webcast: https://www.webmeeting.att.com . Meeting#: 5114686455 . CODE: 307694
• Goto Meeting: https://www2.gotomeeting.com/join/567159050

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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

• CTRR Domain Analysis Model

• CTRR Message Specification

• CTRR Data Requirements to BRIDG Model Element Mapping . (Requires Excel 2007)

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HL7 CTRR Ballot Reconciliation for May 2010

RCRIM Approved Ballot Reconciliation Results

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HL7 Voting Introduction

• HL7 Voting - pdf

or

• HL7 Voting Background - Part 1
• HL7 Voting Ballot Desktop - Part 2
• HL7 Voting Understanding the Ballot Materials - Part 3
• HL7 Voting Casting Ballot - Part 4

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Other HL7 Educational Materials

• HL7 v3 Reference Models Introduction - Part 1

• HL7 v3 Reference Models Introduction - Part 2

• 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 Plan

• HL7 CTRR DSTU Testing Plan

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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!!