Difference between revisions of "Periodic Reporting of Clinical Trial Laboratory Data, Release 2"
(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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| − | ''Project | + | ''Project Number'' '''271''' |
| − | ''Project | + | ''Project Name'' '''Periodic Reporting of Clinical Trial Laboratory Data, Release 2''' |
| − | '' | + | ''Project Sponsor(s)'' [[Regulated Clinical Research Information Management|RCRIM Work Group]] |
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| + | ==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. | 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. | ||
| − | + | ==Objectives / Deliverables== | |
| + | * Storyboard | ||
| + | * Application Roles | ||
| + | * Trigger Events | ||
| + | * Interaction Diagram | ||
| + | * Refined Message Information Model | ||
| + | * Hierarchical Message Definition | ||
| + | ==Project Scope Details== | ||
''Project Facilitator'' Ed Tripp | ''Project Facilitator'' Ed Tripp | ||
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''PMO Approval Date'' Feb 10, 2006 | ''PMO Approval Date'' Feb 10, 2006 | ||
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''Dependancies'' Clinical Genomics SIG Genotype CMET | ''Dependancies'' Clinical Genomics SIG Genotype CMET | ||
''Start Date'' Jan 10, 2006 | ''Start Date'' Jan 10, 2006 | ||
Revision as of 17:52, 12 December 2008
Return to RCRIM main page
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.
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
