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Difference between revisions of "Clinical Trials Registration and Results"

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[[Category:RCRIM]]
 
Return to [[Regulated Clinical Research Information Management|RCRIM]] main page
 
Return to [[Regulated Clinical Research Information Management|RCRIM]] main page
  
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This document was amended and approved by RCRIM on November 25, 2008
 
This document was amended and approved by RCRIM on November 25, 2008
  
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[http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=372 CTR&R Project Scope]
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[http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=372 CTR&R Project Scope] - From project Insight
 +
 
 +
[http://gforge.hl7.org/svn/rcrim/trunk/Project%20Scope%20Statements/2009JAN_PROJSCOPE_RCRIM_Ed_Helton_Clinical_Trial_Reg_And_Results_v2.doc CTR&R Project Scope]  - MSWord File
  
 
Approved Project Charter on January 21, 2009:
 
Approved Project Charter on January 21, 2009:
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[http://wiki.hl7.org/images/8/83/HL7_CTR%26R_Public_Meeting_-_Dec_10th.zip Public Meeting Presentation]
 
[http://wiki.hl7.org/images/8/83/HL7_CTR%26R_Public_Meeting_-_Dec_10th.zip Public Meeting Presentation]
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 +
Presentation from the June 17, 2010 - DIA Annual Meeting:
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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]
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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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==Project Leads==
 
==Project Leads==
 
If you have any issues or concerns, please contact one of the following:
 
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
 
Ed Helton (NCI) – heltone2@mail.nih.gov
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Tracy Beck (Lilly) - becktj@lilly.com
 
Tracy Beck (Lilly) - becktj@lilly.com
  
−
Kristofer Spahr (Merck) - kristofer_spahr@merck.com
+
Sarah Larson (Genzyme) - Sarah.Larson@genzyme.com
  
−
Scott Getzin (Lilly) – sgetzin@lilly.com
 
  
 
.
 
.
  
−
==Project Meeting Minutes==
+
==Project Working Documents==
−
[[CTRR Meeting Minutes]]
 
  
 +
Active Working Documents are stored on GFORGE:
 +
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[http://gforge.hl7.org/gf/project/ctrr/scmsvn/?action=browse&path=%2Ftrunk%2F CTRR - GFORGE Location]
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 +
Other CTRR Historical Documents:
  
−
==Project Working Documents==
 
 
[[CTRR Working Documents]]
 
[[CTRR Working Documents]]
  
 +
.
  
 
==Project Team Participation==
 
==Project Team Participation==
 
[http://wiki.hl7.org/images/7/7e/How_to_get_connected_to_the_Clinical_Trial_Registration_and_Results.doc How to Get Connected]
 
[http://wiki.hl7.org/images/7/7e/How_to_get_connected_to_the_Clinical_Trial_Registration_and_Results.doc How to Get Connected]
 +
*  Telecom:  770-657-9270  .  Passcode: 7458962
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*  Goto Meeting:  https://www2.gotomeeting.com/join/567159050
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 +
 +
.
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==HL7 CTRR Ballot Materials - May 2010 - DSTU==
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*  The XSD, HDM, JPG and VSD files are contained in the attached [http://wiki.hl7.org/images/b/ba/CTRR_-_Schema_-_PORT_MT140001UV.zip zip file]
 +
 +
*  Additional HL7 Core Schemas required for the above CTRR schema [http://wiki.hl7.org/images/9/9a/HL7_Addl_core_schemas.zip zip file]
 +
 +
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*  [http://wiki.hl7.org/images/e/ea/CTRR_Domain_Analysis_Model.zip CTRR Domain Analysis Model]
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*  [http://wiki.hl7.org/images/c/cb/CTRR_Message_Specification.zip CTRR Message Specification]
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*  [http://wiki.hl7.org/images/1/16/CTRR_Data_Requirements_to_BRIDG_Model_Element_Mapping.zip CTRR Data Requirements to BRIDG Model Element Mapping]  .  (Requires Excel 2007)
 +
 +
.
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==HL7 CTRR Ballot Reconciliation for May 2010==
  
 +
[http://wiki.hl7.org/images/2/22/CTRR_-_May_2010_-_Ballot_Reconciliation_20101006.zip RCRIM Approved Ballot Reconciliation Results]
 +
 +
.
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==HL7 Voting Introduction==
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*  [http://www.hl7.org/Library/Committees/rcrim/HL7%20Voting.pdf  HL7 Voting - pdf]
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 +
or
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*  [http://wiki.hl7.org/images/e/ee/HL7_Voting_-_Background_-_Part_1.zip HL7 Voting Background - Part 1]
 +
*  [http://wiki.hl7.org/images/f/fe/HL7_Voting_The_Ballot_Desktop_-_Part_2.zip HL7 Voting Ballot Desktop - Part 2]
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*  [http://wiki.hl7.org/images/4/4f/HL7_Voting_Understanding_the_HL7_Ballot_Materials_-_Part_3.zip HL7 Voting Understanding the Ballot Materials - Part 3]
 +
*  [http://wiki.hl7.org/images/8/8b/HL7_Voting_Casting_Ballot_-_Part_4.zip HL7 Voting Casting Ballot - Part 4]
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 +
.
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==Other HL7 Educational Materials==
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*  [http://wiki.hl7.org/images/0/02/HL7_v3_Reference_Models_March_2008_-_Part_1.zip HL7 v3 Reference Models Introduction - Part 1]
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*  [http://wiki.hl7.org/images/8/8f/HL7_v3_Reference_Models_March_2008_-_Part_2.zip HL7 v3 Reference Models Introduction - Part 2]
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*  Here is a [http://blogs.sun.com/vishblogs/entry/understanding_hl7_v3_from_developer link] to an article that explains the HL7 message development process and the artifact naming convention.
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 +
.
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==Project Testing Page==
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[[CTRR Testing Page]]
 +
 +
.
  
 
==Overall Project Timeline (subject to change)==
 
==Overall Project Timeline (subject to change)==
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'''February 2010 - Begin Testing  (likely period - 6 to 12 months)'''
+
'''May 2010 – Ballot'''
 +
*  DSTU Ballot - Draft Standard for Trial Use (including EMEA requirements)
 +
 
 +
 
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'''October 2010 - Begin Testing  (likely period - 6 to 12 months)'''
 
*  Develop Implementation Guide based on Testing
 
*  Develop Implementation Guide based on Testing
  
  
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'''January 2011 – Ballot'''
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'''May 2011 – Ballot'''
 
*  Normative Ballot  (providing all ballot materials including the implementation guide)
 
*  Normative Ballot  (providing all ballot materials including the implementation guide)
  
  
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'''February 2011 - Begin Implementation and Production Use!!'''
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'''June 2011 - Begin Implementation and Production Use!!'''

Latest revision as of 14:26, 28 November 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

.

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


.

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

or

.

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!!

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