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.
Contents
- 1 Project Scope
- 2 Project Leads
- 3 Project Working Documents
- 4 Project Team Participation
- 5 HL7 CTRR Ballot Materials - May 2010 - DSTU
- 6 HL7 CTRR Ballot Reconciliation for May 2010
- 7 HL7 Voting Introduction
- 8 Other HL7 Educational Materials
- 9 Project Testing Page
- 10 Overall Project Timeline (subject to change)
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:
Presentation from the December 10, 2008 - Public Meeting:
Presentation from the June 17, 2010 - DIA Annual Meeting:
Project from the September 14, 2011 - 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:
Other CTRR Historical Documents:
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Project Team Participation
- Telecom: 770-657-9270 . Passcode: 745896
- Goto Meeting: https://www2.gotomeeting.com/join/567159050
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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
- 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
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
- 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
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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!!
