HL7 Technical Committee

Mission and Charter Statement

Group Name: Regulated Clinical Research Information Management

HL7 Technical Committee

Mission and Charter Statement

Group Name: Regulated Clinical Research Information Management (RCRIM)

Mission

This committee supports the HL7 mission to create and promote its standards by developing standards to improve or enhance information management during research and regulatory evaluation of the safety and efficacy of therapeutic products or procedures worldwide. The committee defines messages, document structures, and terminology to support the systems and processes used in the collection, storage, distribution, integration and analysis of such information. The work of this committee will facilitate 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 committee 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) technical committee. 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.

Formal Relationships with Other HL7 Groups

None

Formal Relationships with Groups Outside of HL7

This TC is authorized by the HL7 Board of Directors to represent HL7 in a relationship to:

CDISC – Clinical Data Interchange Standards Consortium

Date of Last Revision

DRAFT 21 March 2002

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