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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


RCRIM projects include:

Working Group Meetings

RCRIM Working Group Meeting Agendas

Meeting Minutes

RCRIM Working Group Meeting Minutes

Sub-Teams

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

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/