Regulated Clinical Research Information Management

This page was for the RCRIM TC and is now superseded by the BR&R WG

Please go to Biomedical Research and Regulation (BR&R) for current content

Mission and Charter

Mission

The RCRIM Work Group supports the HL7 mission to create and promote HL7 standards by developing standards to improve or enhance information management during preclinical research, clinical research and regulatory evaluation of the safety, efficacy and quality of therapeutic products and procedures worldwide.

The Work Group defines messages, document structures, terminology and semantics to support the systems and processes used in the collection, storage, distribution, integration and analysis of such information. The main areas of interest are Regulated Products and Regulated Studies generated as a result of protocol driven research in a regulated environment.

The Work Group will facilitate the development of common standards for clinical research information management across a variety of organizations, including national and international government agencies and regulatory bodies, private research efforts, and sponsored research. The ultimate objective is to increase the availability of safe and effective therapies by improving the processes associated with regulated clinical research.

Charter

Work Products and Contributions to HL7 Processes

This Work Group will produce normative standards for the interchange of information about, and generated by, regulated clinical research. This will include responsibility for the content of the clinical trial messages currently part of Version 2. These messages will, however, continue to be presented in a part of the version 2 standard maintained by the Orders and Observations (OO) Work Group. OO will coordinate any balloting and publication of those V2 messages.

In addition, RCRIM will seek to assure that related or supportive standards produced by other HL7 groups are robust enough to accommodate their use in regulated clinical research. The group will also monitor information interchange standards developed outside HL7, and attempt harmonization of information content and representation of such standards with the HL7 content and representation.

The Work Group will develop specifications using the principles and language of the Services Aware Interoperability Framework (SAIF) Canonical Definition (CD) and the restrictions and specializations of
the HL7 SAIF Implementation Guide (IG) to ensure traceability from conceptual to logical to implementable specifications.
 When submitting artifacts or methodology to the HL7 SAIF IG the Work Group will develop this content in compliance with the principles and language of the SAIF CD.


Formal Relationships with Other HL7 Groups

This Work Group will coordinate with a large number of other Work Groups in order to accomplish its mission. Strongest relationships will be with:

• Clinical Genomics
• Clinical Interoperability Council
• Electronic Health Record
• Health Care Devices
• Orders and Observations
• Patient Care
• Patient Safety
• Pharmacy
• Public Health and Emergency Response
• Structured Documents

Formal Relationships with Groups Outside of HL7

This Work Group under a Memorandum of Understanding is authorized by the HL7 Board of Directors to provide liaison to:

• CDISC - Clinical Data Interchange Standards Consortium

Date of Last Revision or Review of Charter

May 8, 2013

Decision Making

see Work Group Decision Making Documents[1]

Training Materials

HL7 Voting - PowerPoint Format

HL7 Voting - PDF Format

Date of Last Revision of Training Material

August 24, 2009

Procedural Documents

BRIDG Harmonization Process and Procedure

Version 1.1, Release 2

August 4, 2009

RCRIM Projects

• Annotated ECG Reaffirmation Project Complete
• BRIDG as DAM
• CDISC Content to Message
• Clinical_Trials_Registration_and_Results
• Drug Stability Reporting
• Laboratory Result-based Adverse Event Assessment Messaging Project
• Medical Product Information (SPLr5)
• Periodic Reporting of Clinical Trial Laboratory Data, Release 2
• Regulated Product Submissions
• Structured_Product_Labeling
• Structured_Product_Labeling for Food and Dietary Supplements (SPLr8)
• FHIR Adverse Event Resource
• (Proposed) Regulated Activity Structure Hierarchy (RASH)

Three Year Plan and SWOT

• RCRIM Three Year Plan
• RCRIM SWOT Analysis

Agenda's and Meeting Minutes and Voting Summaries

• RCRIM Working Group Meeting Agendas
• RCRIM Working Group Meeting Minutes
• RCRIM Teleconference Minutes and Agendas
• RCRIM Electronic Voting

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

ANSI/HL7 SPL, R4

HL7 Version 3 Standard: Structured Product Labeling, Release 4

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

HL7aECG Implementation Guide

HL7 Version 3 Implementation Guide: aECG

Informative Ballot - March 21, 2005

HL7 V3 EDCI,R1

HL7 Version 3 Standard: Regulated Studies; Electronic Data Collection Instrument, Release 1

Last Ballot: DSTU Ballot 2 - May 2008 Ballot and further work Postponed

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

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/