Difference between revisions of "Product CDISC2MSG"
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===Releases=== | ===Releases=== | ||
| + | Study Design: | ||
| + | *HL7 CDISC2MSG SD, R1: HL7 Version 3 Standard: CDISC Content to Message - Study Design, Release 1 | ||
| + | **Last Ballot: DSTU Ballot 2 - September 2009 | ||
*HL7 IG CDISC2MSG SDS, R1: HL7 Version 3 Implementation Guide: CDISC Content to Message - Study Design, Release 1 | *HL7 IG CDISC2MSG SDS, R1: HL7 Version 3 Implementation Guide: CDISC Content to Message - Study Design, Release 1 | ||
| − | **Informative Ballot 1 - September | + | **Informative Ballot 1 - January 2011 |
| + | |||
| + | Study Participation: | ||
| + | *HL7 CDISC2MSG SP, R1: HL7 Version 3 Standard: CDISC Content to Message - Study Participation, Release 1 | ||
| + | **Last Ballot: DSTU Ballot 2 - September 2009 | ||
*HL7 IG CDISC2MSG SP, R1: HL7 Version 3 Implementation Guide: CDISC Content to Message - Study Participation, Release 1 | *HL7 IG CDISC2MSG SP, R1: HL7 Version 3 Implementation Guide: CDISC Content to Message - Study Participation, Release 1 | ||
| − | **Informative Ballot 1 - September 2010 | + | **Informative Ballot 1 - September 2010, January 2011 |
| + | |||
| + | Subject Data: | ||
| + | *HL7 CDISC2MSG SUBJDATA, R1: HL7 Version 3 Standard: CDISC Content to Message - Subject Data, Release 1 | ||
| + | **Last Ballot: DSTU Ballot 1 - September 2009 | ||
| + | |||
===Summary=== | ===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 | + | The project scope is to create HL7 V3 messages from existing content within the CDISC standard. This project will specifically include |
| + | *a) study summary, | ||
| + | *b) eligibility criteria, | ||
| + | *c) trial design (including parts I and II: arms, elements visits, planned assessments, and planned intervention(s)), | ||
| + | *d) statistical analysis plan, | ||
| + | *e) collected data/study data tabulations and | ||
| + | *f) derived data/analysis datasets, all of which are currently defined by the CDISC standard. | ||
| + | |||
| + | During the course of the project it is expected that new requirements will be discussed, but the goal of this project is not to create new data elements. The use case for this project is sending the aforementioned content to a regulatory authority to support a regulatory submission. The CDISC content will be mapped to four HL7 V3 messages as follows: 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: | ||
| + | <br/>The study design message answers the question what is going to be done in a study. The study design message will transport trial design and eligibility criteria information in a standardized format; specifically the study design messages covers arms, epochs, subject assignment, planned encounters (visits), planned interventions, planned observations (assessments), eligibility criteria and study characteristics. | ||
| + | |||
| + | This message is part of a suite of messages surrounding regulated studies. | ||
| + | |||
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 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: | ||
| + | <br/> | ||
| + | The study participation message answers the question who is involved in one particular study (i.e., two studies would have two different study participation messages). | ||
| + | |||
| + | The Study Participation message is intended to inform the agency about all experimental units, investigators, and other relevant entities that are involved in the conduct of an individual study. A study in this context is any investigation performed to support the safety, effectiveness, or quality of a medical product. As such, the experimental unit of a study can be a human, other nonhuman living subjects, parts ofnonhuman living subjects, groups of nonhuman living subjects, or the medical product itself. | ||
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. | 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. | ||
| + | |||
| + | Subject Data: | ||
| + | <br/>In performing a study on specified intervention on a specified population, a submission is sent to a regulatory authority that contains all of the data and audit trail about the experimental units within the study. This data is linked to the study design message. This message will be submitted within a Regulated Product Submission message. | ||
| + | |||
| + | The initial message will only support a review request. In subsequent release, acknowledgment will be provided to the applicant. The Regulated Product Submission message will have the ability to update or replace the message/document. | ||
| + | |||
| + | |||
===Business Case (Intended Use, Customers)=== | ===Business Case (Intended Use, Customers)=== | ||
| − | Regulatory | + | Regulatory authorites, pharmaceutical and other regulated industries conducting clinical studies |
===Benefits=== | ===Benefits=== | ||
Latest revision as of 14:00, 1 November 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
Study Design:
- HL7 CDISC2MSG SD, R1: HL7 Version 3 Standard: CDISC Content to Message - Study Design, Release 1
- Last Ballot: DSTU Ballot 2 - September 2009
- HL7 IG CDISC2MSG SDS, R1: HL7 Version 3 Implementation Guide: CDISC Content to Message - Study Design, Release 1
- Informative Ballot 1 - January 2011
Study Participation:
- HL7 CDISC2MSG SP, R1: HL7 Version 3 Standard: CDISC Content to Message - Study Participation, Release 1
- Last Ballot: DSTU Ballot 2 - September 2009
- HL7 IG CDISC2MSG SP, R1: HL7 Version 3 Implementation Guide: CDISC Content to Message - Study Participation, Release 1
- Informative Ballot 1 - September 2010, January 2011
Subject Data:
- HL7 CDISC2MSG SUBJDATA, R1: HL7 Version 3 Standard: CDISC Content to Message - Subject Data, Release 1
- Last Ballot: DSTU Ballot 1 - September 2009
Summary
The project scope is to create HL7 V3 messages from existing content within the CDISC standard. This project will specifically include
- a) study summary,
- b) eligibility criteria,
- c) trial design (including parts I and II: arms, elements visits, planned assessments, and planned intervention(s)),
- d) statistical analysis plan,
- e) collected data/study data tabulations and
- f) derived data/analysis datasets, all of which are currently defined by the CDISC standard.
During the course of the project it is expected that new requirements will be discussed, but the goal of this project is not to create new data elements. The use case for this project is sending the aforementioned content to a regulatory authority to support a regulatory submission. The CDISC content will be mapped to four HL7 V3 messages as follows: 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:
The study design message answers the question what is going to be done in a study. The study design message will transport trial design and eligibility criteria information in a standardized format; specifically the study design messages covers arms, epochs, subject assignment, planned encounters (visits), planned interventions, planned observations (assessments), eligibility criteria and study characteristics.
This message is part of a suite of messages surrounding regulated studies.
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:
The study participation message answers the question who is involved in one particular study (i.e., two studies would have two different study participation messages).
The Study Participation message is intended to inform the agency about all experimental units, investigators, and other relevant entities that are involved in the conduct of an individual study. A study in this context is any investigation performed to support the safety, effectiveness, or quality of a medical product. As such, the experimental unit of a study can be a human, other nonhuman living subjects, parts ofnonhuman living subjects, groups of nonhuman living subjects, or the medical product itself.
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.
Subject Data:
In performing a study on specified intervention on a specified population, a submission is sent to a regulatory authority that contains all of the data and audit trail about the experimental units within the study. This data is linked to the study design message. This message will be submitted within a Regulated Product Submission message.
The initial message will only support a review request. In subsequent release, acknowledgment will be provided to the applicant. The Regulated Product Submission message will have the ability to update or replace the message/document.
Business Case (Intended Use, Customers)
Regulatory authorites, 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
