Regulated Products
 HL7 RPS DSTU R2 HL7 Version 3 Standard: Regulated Product Submission, Release 2 August 2010 |
 HL7 IG RPS, R1-2008 HL7 Version 3 Implementation Guide: Regulated Product Submission, Release 1 May 2008 |
HL7 SPL DSTU R5 HL7 Version 3 Standard: Structured Product Labeling, Release 5 June 2011 |
HL7 IG SPL R5 INFORM 2011MAY HL7 Version 3 Implementation Guide: Structured Product Labeling, Release 5 May 2011 |
| Responsible Group | Regulated Clinical Research Information Management Work Group HL7 |
| RCRIM Publishing Facilitator | Julie Evans jevans@cdisc.org CDISC |
| 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 |
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Content Last Edited: 2011-06-15T14:43:21
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Table of Contents
Preface
i Notes to Readers
ii Message Design Element Navigation
1 Overview
1.1 Introduction & Scope
1.2 Domain Information Models
2 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 2 Implementation Guide
3 Structured Product Labeling (SPL) Release 5 Topic
3.1 Introduction
3.2 Storyboards
3.3 Application Roles
3.4 Trigger Events
3.5 Refined Message Information Models
3.6 Hierarchical Message Descriptions
3.7 Interactions
3.A Implementation Guide for SPL R5
4 Quality Analysis Report Topic
5 CMETs Used by this Domain
6 Interactions Annex
6.1 By Application Role
6.2 By Trigger Event
6.3 By Message Type
7 Glossary
In the 2011 Normative Edition, the Regulated Products domain contains two "topics" as outlined below.
Regulated Product Submission R2 topic
- Regulated Product Submission, Release 2 - HL7 Draft Standard for Trial Use
- Regulated Product Submission R2 Implementation Guide - HL7 Informative Document
Structured Product Labeling R5 topic
- Structure Product Labeling, Release 5 - HL7 Draft Standard for Trial Use
- Structured Product Labeling Release 5 Implementation Guide - HL7 Informative Document
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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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