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Periodic Reporting of Clinical Trial Laboratory Data, Release 2

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Revision as of 16:42, 13 October 2008 by Trippes (talk | contribs) (New page: ''Pr''Italic text''oject Number'' 271 ''Project Name'' Periodic Reporting of Clinical Trial Laboratory Data, Release 2 ''Project Sponsor(s)'' RCRIM Work Group ''Description'' Pharmaco...)
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PrItalic textoject Number 271

Project Name Periodic Reporting of Clinical Trial Laboratory Data, Release 2

Project Sponsor(s) RCRIM Work Group

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

SD Approval Date Feb 10, 2006

TSC Approval Date Feb 10, 2006

PMO Approval Date Feb 10, 2006

Objectives / Deliverables

  • Storyboard
  • Application Roles
  • Trigger Events
  • Interaction Diagram
  • Refined Message Information Model
  • Hierarchical Message Definition

Dependancies Clinical Genomics SIG Genotype CMET

Start Date Jan 10, 2006

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