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| + | [[Category:RCRIM]] | ||
| + | Return to [[Regulated Clinical Research Information Management|RCRIM]] main page | ||
| + | |||
'''Clinical Trials Registration and Results - WIKI 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. | 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] | ||
| + | Presentation from the June 17, 2010 - 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] | ||
| + | |||
| + | Project from the September 14, 2011 - DIA - CT Disclosure Meeting: | ||
| + | |||
| + | [http://wiki.hl7.org/images/0/08/DIA_Sept_2011-_Getzin_-_Clinical_Trial_Registration_and_Results_Project_Update.pptx DIA CT Disclosure Meeting] | ||
| + | |||
| + | . | ||
| + | |||
| + | ==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 | ||
| Line 16: | Line 40: | ||
Tracy Beck (Lilly) - becktj@lilly.com | Tracy Beck (Lilly) - becktj@lilly.com | ||
| − | + | Sarah Larson (Genzyme) - Sarah.Larson@genzyme.com | |
| + | |||
| + | |||
| + | . | ||
| + | |||
| + | ==Project Working Documents== | ||
| + | |||
| + | Active Working Documents are stored on GFORGE: | ||
| + | |||
| + | [http://gforge.hl7.org/gf/project/ctrr/scmsvn/?action=browse&path=%2Ftrunk%2F CTRR - GFORGE Location] | ||
| + | |||
| + | Other CTRR Historical 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: 7458962 | ||
| + | * Goto Meeting: https://www2.gotomeeting.com/join/567159050 | ||
| + | |||
| + | |||
| + | . | ||
| + | |||
| + | ==HL7 CTRR Ballot Materials - May 2010 - DSTU== | ||
| + | * 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] | ||
| + | |||
| + | |||
| + | * [http://wiki.hl7.org/images/e/ea/CTRR_Domain_Analysis_Model.zip CTRR Domain Analysis Model] | ||
| + | |||
| + | * [http://wiki.hl7.org/images/c/cb/CTRR_Message_Specification.zip CTRR Message Specification] | ||
| + | |||
| + | * [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) | ||
| + | |||
| + | . | ||
| + | |||
| + | ==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] | ||
| + | |||
| + | . | ||
| + | |||
| + | ==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] | ||
| + | |||
| + | . | ||
| + | |||
| + | ==Other HL7 Educational Materials== | ||
| + | * [http://wiki.hl7.org/images/0/02/HL7_v3_Reference_Models_March_2008_-_Part_1.zip HL7 v3 Reference Models Introduction - Part 1] | ||
| + | |||
| + | * [http://wiki.hl7.org/images/8/8f/HL7_v3_Reference_Models_March_2008_-_Part_2.zip HL7 v3 Reference Models Introduction - Part 2] | ||
| + | |||
| + | * 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. | ||
| + | |||
| + | . | ||
| + | |||
| + | ==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!!''' | |
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.
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:
.
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:
Other CTRR Historical Documents:
.
Project Team Participation
- Telecom: 770-657-9270 . Passcode: 7458962
- Goto Meeting: https://www2.gotomeeting.com/join/567159050
.
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)
.
HL7 CTRR Ballot Reconciliation for May 2010
RCRIM Approved Ballot Reconciliation Results
.
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
.
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
.
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!!
