Regulated Clinical Research Information Management

Main Page | Regulated Clinical Research Information Management (RCRIM)

This page is for the RCRIM TC

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

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

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/