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Regulated Clinical Research Information Management
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
ANSI/HL7 V3 ECG,R1-2004
- HL7 Version 3 Standard: Regulated Studies - Annotated ECG, Release 1
- 5/06/2004
HL7 V3 EDCI,R1
- HL7 Version 3 Standard: Regulated Studies; Electronic Data Collection Instrument, Release 1
- Last Ballot: DSTU Ballot 2 - May 2008
HL7 V3 CRFQ,R1
- HL7 Version 3 Standard: Regulated Studies; Clinical Research Filtered Query (CRFQ) Service Functional Model, Release 1
- Last Ballot: DSTU Ballot 1 - January 2008
HL7 DSR, R2
- HL7 Version 3 Standard: Drug Stability Reporting (eStability), Release 2
- DSTU Ballot 2 - January 2009
HL7 IG DSR, R2
- HL7 Version 3 Implementation Guide: Drug Stability Reporting (eStability), Release 2
- Informative Ballot 2 - January 2009
HL7 CDISC3MSG SD, R1
- HL7 Version 3 Standard: CDISC Content to Message - Study Design, Release 1
- Draft for Comment Ballot 1 - January 2009
HL7 DAM CDISC3MSG SP, R1
- HL7 Version 3 Domain Analysis Model: CDISC Content to Message - Study Design, Release 1
- Not Balloting This Cycle
HL7 CDISC3MSG SP, R1
- HL7 Version 3 Standard: CDISC Content to Message - Study Participation, Release 1
- Draft for Comment Ballot 1 - January 2009
HL7 DAM CDISC3MSG SP, R1
- HL7 Version 3 Domain Analysis Model: CDISC Content to Message - Study Participation, Release 1
- Informative Ballot 1 - January 2009
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/