Periodic Reporting of Clinical Trial Laboratory Data, Release 2

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Project 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.

CTLab r2 Project Scope Statement

Objectives / Deliverables

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

Project Scope Details

Project Facilitator Ed Tripp

SD Approval Date Feb 10, 2006

TSC Approval Date Feb 10, 2006

PMO Approval Date Feb 10, 2006

Dependancies Clinical Genomics SIG Genotype CMET

Start Date Jan 10, 2006