Project Summary for Periodic Reporting of Clinical Trial Laboratory Data, Release 2
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Project Details
Number | 271 View Ballot Items List (with NIBs) |
---|---|
Name | Periodic Reporting of Clinical Trial Laboratory Data, Release 2 |
Sponsor(s) | Biomedical Research and Regulation Work Group |
Co-Sponsor(s) | |
Steering Division | Clinical |
Description | Pharmacogenomics data have been added in this release of the Periodic Reporting of Clinical Trial Laboratory Data standard. These additions will allow the message to be used to transmit sequence and microarray based pharmacogenomics data (and the significant findings, genotypes and phenotypes derived from the raw data) between the laboratories, pharmaceutical companies and regulatory agencies involved in a regulated clinical research study. |
Project Facilitator | Ed Tripp |
Status | Archived |
SD Approval Date | Feb 10, 2006 |
TSC Approval Date | Feb 10, 2006 |
Type | Ballot - Normative (no STU) |
Objectives / Deliverables | - Storyboard - Application Roles - Trigger Events - Interaction Diagram - Refined Message Information Model - Hierarchical Message Definition All products to be delivered by February 19, 2006 |
Next Milestone Date | 2010 May WGM |
Project End Date | 2010 May WGM |
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Dependancies | Clinical Genomics SIG Genotype CMET |
Project Document Repository |
http://gforge.hl7.org/gf/project/rcrim/docman/?subdir=253; http://wiki.hl7.org/index.php?title=Periodic_Reporting_of_Clinical_Trial_Laboratory_Data%2C_Release_2; |
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Realm | - Choose One - |
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Misc Notes | April 4, 2011 TSC Conference Call: In accordance with the HL7 GOM Section 14.14, the TSC approved the petition to withdraw this standards project. March 2011: Ed Tripp: We don’t see either standard as being useful or easy to implement as currently described and would like to withdraw the work. We may put forward a project to develop a V2.5.1 IG to leverage what O&O has developed around transmission of lab data. We may also develop a v3 message that leverages O&O CMETS but that is too be discussed further. Given that, KAren recommended closing this project. (email trail in Project Insight Documents folder) Nov 2010: (LL) per RCRIM three-year planning document they've placed the project on hold (lack of support/implementation following DSTU period to take it normative). Updated status to reflect. Sept 2010: DSTU Test Period ended March 24, 2010. http://www.hl7.org/dstucomments/ex_showdetail.cfm?dstuid=37 July 2010: updated project repository URLs Nov 01, 2007 - DSTU Expired for HL7 Version 3 Standard: Periodic Reporting of Clinical Trial Laboratory Data, Release 2 |
U.S. Govt Interest? | |
USRSC Approval | |
FMG Approval | |
ARB Approval | |
Start Date | Jan 10, 2006 |
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