View source for 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

[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:

[http://wiki.hl7.org/images/b/b4/CTRR_Project_Charter_-_Version_1.0.doc Project Charter Version 1.0]

Presentation from the December 10, 2008 - Public Meeting:

[http://wiki.hl7.org/images/8/83/HL7_CTR%26R_Public_Meeting_-_Dec_10th.zip Public Meeting Presentation]

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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==
[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: 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==
*  [http://wiki.hl7.org/images/2/28/CTRR_Clinical_Trial_Registration_Ballot_Materials.zip CTRR Ballot Materials - Part 1]
*  [http://wiki.hl7.org/images/f/ff/CTRR_Ballot_Material_20091128.zip CTRR Ballot Materials - Part 2]


==HL7 Voting Introduction==
*  [http://www.hl7.org/Library/Committees/rcrim/HL7%20Voting.pdf  HL7 Voting - pdf]

or

*  [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]
*  [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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==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)


'''June 2010 - Begin Testing  (likely period - 6 to 12 months)'''
*  Develop Implementation Guide based on Testing


'''January 2011 – Ballot'''
*  Normative Ballot  (providing all ballot materials including the implementation guide)


'''February 2011 - Begin Implementation and Production Use!!'''