Product CDISC2MSG

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

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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.

Resources

Work Groups

• RCRIM

Education

• See more at http://www.hl7.org/implement/training.cfm

Certification Available

• none

Links to current projects in development

• Project Insight ID # 205,