Regulated Clinical Research Information Management

Mission

This Work Group supports the HL7 mission to create and promote HL7 standards by developing RCRIM standards to improve or enhance information management during clinical research and regulatory evaluation of the safety, efficacy and quality of therapeutic products and procedures worldwide. The Work Group defines messages, document structures, and terminology to support the systems and processes used in the collection, storage, distribution, integration and analysis of such information. Areas of interest are Products and Studies generated as a result of protocol driven research in a regulated environment.

 

RCRIM BRIDG Domain Analysis with example topic areas

 

This 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 -- and thus the availability of safe and effective therapies by improving the processes and efficiencies 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 Relationship 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

 

Decision Making Practices

Decision Making Practices

Date of Last Revision

May 6, 2013