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Difference between revisions of "Product CDISC2MSG"

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(New page: {{subst::Product_Brief}})
 
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=Product Brief - =
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=Product Brief - HL7 V3 Regulated Studies: CDISC Content to Message =
 
__TOC__
 
__TOC__
 
back to [[Main_Page]]<br/>back to [[Product_List]]
 
back to [[Main_Page]]<br/>back to [[Product_List]]
 
==Product Name==
 
==Product Name==
−
<!--from project scope statement, section 1, Project Name-->
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HL7 Version 3 Regulated Studies: CDISC Content to Message
  
 
===Topics===
 
===Topics===
−
<!--from ?? ballot site?? project scope statement, section ??-->
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*Study Design
−
*
+
*Study Participation
 +
*Subject Data
 +
 
 +
 
 
===Standard Category===
 
===Standard Category===
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<!--from ?? project scope statement??,
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*Health Information Exchange Standards
−
Exchange, Modeling, Knowledge Representation, Foundation, etc. -->
+
 
−
*
+
 
 
===Integration Paradigm===
 
===Integration Paradigm===
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<!--from project scope statement, section 1, Products,
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*Messaging
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choose Messages, Documents, Services, Foundation -->
+
 
−
*
 
 
===Type===
 
===Type===
−
<!--from project scope statement, section 2.a, Ballot Type-->
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Informative
  
 
===Releases===
 
===Releases===
−
<!--derive from project scope statement, section 1, Project Name, Section 2, Project Intent, and ballot history-->
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*HL7 IG CDISC2MSG SDS, R1: HL7 Version 3 Implementation Guide: CDISC Content to Message - Study Design, Release 1
 +
**Informative Ballot 1 - September 2010
 +
*HL7 IG CDISC2MSG SP, R1: HL7 Version 3 Implementation Guide: CDISC Content to Message - Study Participation, Release 1
 +
**Informative Ballot 1 - September 2010
 +
 
  
 
===Summary===
 
===Summary===
−
<!--from project scope statement, section 4, Project Definition 4a Project Scope-->
+
The project scope is to create HL7 V3 messages from existing content within the CDISC standard. Proposed HL7 Message: Study Design CDISC Content (from Exploratory Project Charter): a) Study Summary b) Eligibility Criteria c) Trial Design d) Statistical Analysis Plan.
  
 
===Description===
 
===Description===
 +
Study Design Implementation Guide: This implementation guide describes how to implement the HL7 Version 3 Standard: Regulated Studies; CDISC Content to Message - Study Design. A New Protocol submission contains information about what will be done, including planned analyses, etc. The study design message transports study summary, trial design, eligibility criteria, and statistical analysis plan.
  
 +
Study Participation Implementation Guide. The Study Participation message is intended to transmit information about all experimental subjects, investigators, and other relevant entities that are involved in the conduct of an individual clinical study.
  
 
===Business Case (Intended Use, Customers)===
 
===Business Case (Intended Use, Customers)===
−
<!--from project scope statement, section 6.a, Stakeholders/Vendors/Providers-->
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Regulatory authories, pharmaceutical and other regulated industries conducting clinical studies
  
 
===Benefits===
 
===Benefits===
−
<!--from project scope statement, section 4b, Project Need-->
+
This implementation guide supports future legislative need for the Study Design Message and Study Participation information.
  
 
===Implementations/ Case Studies (Actual Users)===
 
===Implementations/ Case Studies (Actual Users)===
−
<!--from project scope statement, section 3, Sponsoring Groups, Implementers-->
 
−
 
  
 
===Resources===
 
===Resources===
  
 
====Work Groups====
 
====Work Groups====
−
<!--from project scope statement, section 3, Sponsoring Groups (Primary and Co-sponsor)-->
+
*[http://www.hl7.org/Special/committees/rcrim/index.cfm RCRIM]
−
http://www.hl7.org/Special/committees/xyz/index.cfm
+
 
 
====Education====
 
====Education====
 
<!--from ??  -->
 
<!--from ??  -->
Line 48: Line 54:
 
* See more at http://www.hl7.org/implement/training.cfm
 
* See more at http://www.hl7.org/implement/training.cfm
 
=====Certification Available=====
 
=====Certification Available=====
−
<!--from project scope statement, ??-->
 
 
*none
 
*none
  
 
====Presentations====
 
====Presentations====
−
<!--from project scope statement, ??-->
 
 
*
 
*
 +
 
===Relationship to/ Dependencies on, other standards===
 
===Relationship to/ Dependencies on, other standards===
−
<!--from project scope statement, ??-->
 
 
*
 
*
 +
 
===Links to current projects in development===
 
===Links to current projects in development===
−
<!---------------from project scope statement,
+
*[http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=205 Project Insight ID # 205],
−
Project ID from Section 1;
 
−
Section 4e: Project Dependencies,
 
−
others??? ------------------------>
 
−
*[http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=xxx Project Insight ID # xxx],
 

Revision as of 17:22, 28 October 2010

Product Brief - HL7 V3 Regulated Studies: CDISC Content to Message

back to Main_Page
back to Product_List

Product Name

HL7 Version 3 Regulated Studies: CDISC Content to Message

Topics

  • Study Design
  • Study Participation
  • Subject Data


Standard Category

  • Health Information Exchange Standards


Integration Paradigm

  • Messaging

Type

Informative

Releases

  • HL7 IG CDISC2MSG SDS, R1: HL7 Version 3 Implementation Guide: CDISC Content to Message - Study Design, Release 1
    • Informative Ballot 1 - September 2010
  • HL7 IG CDISC2MSG SP, R1: HL7 Version 3 Implementation Guide: CDISC Content to Message - Study Participation, Release 1
    • Informative Ballot 1 - September 2010


Summary

The project scope is to create HL7 V3 messages from existing content within the CDISC standard. Proposed HL7 Message: Study Design CDISC Content (from Exploratory Project Charter): a) Study Summary b) Eligibility Criteria c) Trial Design d) Statistical Analysis Plan.

Description

Study Design Implementation Guide: This implementation guide describes how to implement the HL7 Version 3 Standard: Regulated Studies; CDISC Content to Message - Study Design. A New Protocol submission contains information about what will be done, including planned analyses, etc. The study design message transports study summary, trial design, eligibility criteria, and statistical analysis plan.

Study Participation Implementation Guide. The Study Participation message is intended to transmit information about all experimental subjects, investigators, and other relevant entities that are involved in the conduct of an individual clinical study.

Business Case (Intended Use, Customers)

Regulatory authories, pharmaceutical and other regulated industries conducting clinical studies

Benefits

This implementation guide supports future legislative need for the Study Design Message and Study Participation information.

Implementations/ Case Studies (Actual Users)

Resources

Work Groups

Education

Certification Available
  • none

Presentations

Relationship to/ Dependencies on, other standards

Links to current projects in development

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