![]() HL7 RPS R2 DSTU R2 HL7 Version 3 Standard: Regulated Product Submission, Release 2, DSTU Release 2 November 2012 |
![]() HL7 IG RPS, R1-2008 HL7 Version 3 Implementation Guide: Regulated Product Submission, Release 1 May 2008 |
Responsible Group | Regulated Clinical Research Information Management Work Group HL7 |
RCRIM Co-Chair | Ed Helton SAS |
RCRIM PORP Publishing Facilitator | Peggy Leizear peggy.leizear@fda.hhs.gov US Food and Drug Administration |
RCRIM Co-Chair | Randy Levin US Food and Drug Administration |
RCRIM Modeling and Methodology Coordinator | Charles Mead Booz Allen Hamilton |
Primary Contributor | Jason Rock jason.rock@globalsubmit.com GlobalSubmit, Inc |
Editor (SPL) | Gunther Schadow Regenstrief Institute, Indiana University School of Informatics |
RCRIM Co-Chair | Barbara Tardiff Merck |
RCRIM Co-Chair | Edward Tripp Abbott |
RCRIM Modeling and Methodology Coordinator | Mead Walker Mead Walker Consulting |
Primary Contributor | Mead Walker Mead Walker Consulting |
HTML Generated: 2012-10-25T15:44:11
Content Last Edited: 2012-10-25T15:37:14
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For this DSTU publication the Regulated Products domain contains one documentorganized as a "topic" as outlined below. The ballotable document is indicated in bold italic font.
Regulated Product Submission domain
Since its first publication as a DSTU in August 2012, the Regulated Product Submittions topic has undergone two DSTU Update ballots, the first in September 2011 and the second in January 2012. Subsequent to that second DSTU Update ballot, the material has been approved as an HL7 International Draft Standard for Trial Use.
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This domain includes standards developed as part of the family of messages targeted for the exchange of information about regulated products and the exchange of the data needed to provide approval for such products.
The principal contributor to this domain is the Regulated Clinical Research Information Management (RCRIM) technical committee.
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.
SCOPE
The Regulated Products domain currently contains specifications addressing Regulated Product Submission, and Structured Product Labeling. The topics in this domain support approval of regulated products that includes, but is not limited to, medical devices, drugs, biologics, veterinary medicine, and food and feed additives.
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