Regulated Products

HL7 Draft Standard for Trial Use
HL7 RPS R2 DSTU R2
HL7 Version 3 Standard: Regulated Product Submission, Release 2, DSTU Release 2
November 2012
HL7 Informative Document
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

Content Last Edited: 2012-10-25T15:37:14



Table of Contents


Preface
    i Notes to Readers
    ii Changes from Previous DSTU Release
    iii Message Design Element Navigation
Overview
    1.1 Introduction & Scope
    1.2 Domain Information Models
Regulated Product Submission Topic
    2.1 Introduction
    2.2 Storyboards
    2.3 Application Roles
    2.4 Trigger Events
    2.5 Refined Message Information Models
    2.6 Hierarchical Message Descriptions
    2.7 Interactions
    2.A Regulated Product Submission Release 1 Implementation Guide
Quality Analysis Report Topic
4  CMETs Used by this Domain
5  Interactions Annex
    5.1 By Application Role
    5.2 By Trigger Event
    5.3 By Message Type
6  Glossary

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

  • Regulated Product Submission, Release 2 - Draft Standard for Trial Use Release 2

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.

 Regulated Product Submission Topic ()
 
pointer Regulated Product Submission (PORP_RM000001UV01

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.

Return to top of page