Regulated Studies
 HL7 SDS SD, R1 HL7 Version 3 Standard: Study Design; Structured Document, Release 1 DSTU Ballot 1 - May 2012 |
 HL7 CRFQSFM, R1 HL7 Version 3 Standard: Regulated Studies; Clinical Research Filtered Query (CRFQ) Service Functional Model, Release 1 Last Ballot: DSTU Update Ballot 1 - January 2012 |
CDAR2 IG EXCTSD PATNARR, R1 HL7 Implementation Guide for CDA Release 2: Exchange of Clinical Trial Subject Data; Patient Narratives, Release 1 Last Ballot: DSTU Ballot 1 - January 2012 |
| Responsible Group | Regulated Clinical Research Information Management Work Group HL7 |
| Primary Contributor - CTR&R | Scott Getzin Lilly, Inc. |
| Publishing Facilitator | Becky Angeles ScenPro, Inc. |
| RCRIM Co-Chair | Dave Iberson-Hurst CDISC |
| CTLabR2 Primary Contributor | Clinical Genomics SIG HL7 |
| aECG Primary Contributor | Barry Brown Mortara Instruments |
| CTLab Primary Contributor | CDISC Laboratory Standards Team Clinical Data Standards Interchange Consortium (CDISC) |
| Publishing Facilitator | Julie Evans Clinical Data Standards Interchange Consortium (CDISC) |
| Stability Primary Contributor | Norman Gregory US Food and Drug Administration |
| RCRIM Co-Chair | Edward Helton National Cancer Institute |
| CTLabR3 Primary Contributor | Jennifer L. Neat City of Hope |
| Primary Contributor | Phil Pochon Covance |
| Primary Contributor - Study Participation and Study Design | Jason Rock jason.rock@globalsubmit.com GlobalSubmit |
| Primary Contributor | Gunther Schadow, M.D., PhD. Regenstrief Institute for Health Care |
| CTLabR3 Facilitator | Abdul-Malik Shakir Shakir Consulting |
| RCRIM Co-Chair | Ed Tripp Independent |
| Facilitator | Mead Walker Mead Walker Consulting |
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Content Last Edited: 2012-03-30T16:01:01
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Table of Contents
Preface
i Notes to Readers
ii Removed Topics
iii Changes from Previous Release
iv Message Design Element Navigation
1 Overview
1.1 Introduction & Scope
1.2 Domain Information Models
2 Clinical Research Filtered Query Service Release 1 Topic
3 Drug Stability Reporting R2 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 Drug Stability Reporting Release 2 Implementation Guide
4 Study Design DAM Topic
5 Study Design Topic
5.1 Introduction
5.2 Storyboards
5.3 Application Roles
5.4 Trigger Events
5.5 Refined Message Information Models
5.6 Hierarchical Message Descriptions
5.7 Interactions
5.A Study Design Implementation Guide
6 Study Participation DAM Topic
7 Study Participation Topic
7.1 Introduction
7.2 Storyboards
7.3 Application Roles
7.4 Trigger Events
7.5 Refined Message Information Models
7.6 Hierarchical Message Descriptions
7.7 Interactions
7.A Study Participation Implementation Guide
8 Clinical Trials Registration and Results Topic
8.1 Introduction
8.2 Storyboards
8.3 Application Roles
8.4 Trigger Events
8.5 Refined Message Information Models
8.6 Hierarchical Message Descriptions
8.7 Interactions
9 CTRR Domain Analysis Model Topic
10 BRIDG Domain Analysis Model Topic
11 Subject Data Topic
11.1 Introduction
11.2 Storyboards
11.3 Application Roles
11.4 Trigger Events
11.5 Refined Message Information Models
11.6 Hierarchical Message Descriptions
11.7 Interactions
11.A Subject Data - Patient Narratives Implementation Guide
12 Study Design Structured Document Topic
12.1 Introduction
12.2 Storyboards
12.3 Application Roles
12.4 Trigger Events
12.5 Refined Message Information Models
12.6 Hierarchical Message Descriptions
12.7 Interactions
13 Quality Analysis Report Topic
14 CMETs Defined by this Domain
15 CMETs Used by this Domain
16 Interactions Annex
16.1 By Application Role
16.2 By Trigger Event
16.3 By Message Type
17 Glossary
In May 2012 the Regulated Studies domain is balloting 1 document. The ballotable document is in bold italics in the list below. The domain is organized under the "topics" as outlined below.
- HL7 Version 3 Standard: Study Design: Structured Document, Release 1 - US Realm (1st DSTU Ballot)
As has been been done with a number of other non-Normative topics in domains that are not actively balloting, some topics in the the Regulated Studies domain have been removed from the V3 Ballot Web site beginning with the January 2010 ballot. This material has been removed because it has not balloted for more than a year. This statement has been inserted as a placeholder to direct readers to previous draft versions of this domain content. The following two topics have been removed from this domain:
- Clinical Research Filtered Query, Release 1
- Clinical Trials Laboratory, Release 2
For those who want to review the ballot version of this content, draft content remains available in previous ballot cycle versions of the V3 Ballot Web Site. The Version 3 Ballot Site Archive provides links to previous ballot web sites. Readers wishing to review the domain material are directed to the September 2009 ballot web site or earlier.
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This domain includes standards developed as part of the family of messages targeted for the exchange of information about the conduct of regulated studies, and the exchange of the data collected during those studies. This family includes, but is not limited to, standards for submission of clinical trial and product stability information and data to a regulatory agency.
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 Studies domain currently contains specifications addressing Product Stability Reporting (to a national regulatory agency), Annotation of ECGs (for submission to a drug regulatory agency); and the Periodic Reporting of Clinical Trial Laboratory Results (to a study sponsor or sponsor's agent).
Summary of Clinical Trial Interactions in the Regulated Studies Domain
An Interaction is the formatted package of data to be exchanged between a named sender and a named receiver in response to a named trigger event.
The diagram above provides a context for understanding all clinical trial interactions in Regulated Studies. Each storyboard will be accompanied with a similar diagram showing only the interactions described in that storyboard.
The large gray boxes represent potential application systems that might be involved in the exchange of Regulated Studies information. There is no expectation that these application systems must reside at different physical locations. Nor need they be under the control of different parties. All application systems could, for example, be present at and managed by the sponsor. Alternatively, they could be distributed among several parties and locations.
The smaller boxes within represent system functionality that should be present in the application system to handle the exchange. These application system functionalities are called Application Roles.
The horizontal arrows represent the actual interchange of information between application roles, using the messages in this domain.
This interaction diagram shows the four clinical trial interactions currently included in this domain.
Also shown are four potential future interactions -- a request for ECG analysis from the study site; a request for ECG analysis from the Sponsor/Agent; a request for laboratory analysis from the study site; and a report of laboratory results from the laboratory to the study site.
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