Difference between revisions of "Product CDISC2MSG"
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Revision as of 17:23, 28 October 2010
Product Brief - HL7 V3 Regulated Studies: CDISC Content to Message
Contents
- 1 Product Brief - HL7 V3 Regulated Studies: CDISC Content to Message
- 1.1 Product Name
- 1.1.1 Topics
- 1.1.2 Standard Category
- 1.1.3 Integration Paradigm
- 1.1.4 Type
- 1.1.5 Releases
- 1.1.6 Summary
- 1.1.7 Description
- 1.1.8 Business Case (Intended Use, Customers)
- 1.1.9 Benefits
- 1.1.10 Implementations/ Case Studies (Actual Users)
- 1.1.11 Resources
- 1.1.12 Relationship to/ Dependencies on, other standards
- 1.1.13 Links to current projects in development
- 1.1 Product Name
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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
- See more at http://www.hl7.org/implement/training.cfm
Certification Available
- none
