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Difference between revisions of "Regulated Clinical Research Information Management"
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[[RCRIM Vocabulary]] | [[RCRIM Vocabulary]] | ||
+ | ==Domains== | ||
+ | ===Regulated Products=== | ||
+ | ====PORP (Regulated Products) Publishing Facilitator==== | ||
+ | Peggy Leizear | ||
+ | peggy.leizear@fda.hhs.gov | ||
+ | US Food and Drug Administration | ||
+ | |||
+ | ====Standards==== | ||
+ | ''''ANSI/HL7 RPS, R1-2008'''' | ||
+ | |||
+ | :HL7 Version 3 Standard: Regulated Product Submission, Release 1 | ||
+ | :3/6/2008 | ||
+ | |||
+ | ''''HL7 IG RPS, R1'''' | ||
+ | |||
+ | :HL7 Version 3 Implementation Guide: Regulated Product Submission, Release 1 | ||
+ | :Last Ballot: Informative Ballot 1 - May 2008 | ||
+ | |||
+ | ''''HL7 SPL, R4'''' | ||
+ | :HL7 Version 3 Standard: Structured Product Labeling, Release 4 | ||
+ | :Last Ballot: Normative Ballot 2 - September 2008 | ||
+ | |||
+ | ''''HL7 IG SPL, R4'''' | ||
+ | :HL7 Version 3 Implementation Guide: Structured Product Labeling, Release 4 | ||
+ | :Informative Ballot 1 - January 2009 | ||
+ | |||
+ | ===Regulated Studies=== | ||
+ | ====PORT (Regulated Studies) Publishing Facilitator==== | ||
+ | Becky Angeles | ||
+ | bangeles@scenpro.com | ||
+ | Scenpro, Inc. | ||
+ | ====Standards==== | ||
==Decision Making== | ==Decision Making== |
Revision as of 21:45, 12 December 2008
Main Page | Regulated Clinical Research Information Management (RCRIM)
This page is for the RCRIM TC
Contents
RCRIM projects include:
- CDISC Content to Message
- Clinical_Trials_Registration_and_Results
- Drug Stability Reporting
- Laboratory Result-based Adverse Event Assessment Messaging Project
- Medical Product and Device Listing
- Periodic Reporting of Clinical Trial Laboratory Data, Release 2
- Regulated Product Submissions
- Structured_Product_Labeling
Working Group Meetings
RCRIM Working Group Meeting Agendas
Meeting Minutes
RCRIM Working Group Meeting Minutes
Sub-Teams
Domains
Regulated Products
PORP (Regulated Products) Publishing Facilitator
Peggy Leizear peggy.leizear@fda.hhs.gov US Food and Drug Administration
Standards
'ANSI/HL7 RPS, R1-2008'
- HL7 Version 3 Standard: Regulated Product Submission, Release 1
- 3/6/2008
'HL7 IG RPS, R1'
- HL7 Version 3 Implementation Guide: Regulated Product Submission, Release 1
- Last Ballot: Informative Ballot 1 - May 2008
'HL7 SPL, R4'
- HL7 Version 3 Standard: Structured Product Labeling, Release 4
- Last Ballot: Normative Ballot 2 - September 2008
'HL7 IG SPL, R4'
- HL7 Version 3 Implementation Guide: Structured Product Labeling, Release 4
- Informative Ballot 1 - January 2009
Regulated Studies
PORT (Regulated Studies) Publishing Facilitator
Becky Angeles bangeles@scenpro.com Scenpro, Inc.
Standards
Decision Making
see Work Group Decision Making Documents[1]
Reference Links
BRIDG file release site http://gforge.nci.nih.gov/frs/?group_id=342
BRIDG Project site http://gforge.nci.nih.gov/projects/bridg-model/