Project Summary for CDA Implementation Guide for the Exchange of Clinical Trial Subject Data: Patient Narratives
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Project Details
Number | 822 View Ballot Items List (with NIBs) |
---|---|
Name | CDA Implementation Guide for the Exchange of Clinical Trial Subject Data: Patient Narratives |
Sponsor(s) | Biomedical Research and Regulation Work Group |
Co-Sponsor(s) | Structured Documents Work Group |
Steering Division | Clinical |
Description | The project will reference the withdrawn Subject Data DSTU V3 message (project 205) as a starting point to limit the scope of the CDA document to create a CDA R2 Implementation Guide. The scope of the CDA implementation guide is limited to the exchange of patient narratives, which are created as a summary document during the conduct of a clinical trial. The CDA Implementation Guide will focus on a constrained dataset that supports the exchange of both human and machine readable content. |
Project Facilitator | Armando Oliva/Patty Garvey |
Status | Archived |
SD Approval Date | Oct 24, 2011 |
TSC Approval Date | Oct 31, 2011 |
Type | Ballot - STU |
Objectives / Deliverables | Complete balloting of implementation guide - Target: May 2012 Successful use of the guide to produce valid FDA test files - Target: June 2012-2014 Project End Date - Target: June 2014 |
Next Milestone Date | 2015 May WGM |
Project End Date | 2015 May WGM |
Project Intent | Implementation Guide |
Project Need | This project builds upon the work begun a few years ago to harmonize CDISC and HL7 standards within the clinical research domain (Project ID 205 CDISC Content to HL7 Messages Project). The Subject Data specification was designed to support the content requirements described in the CDISC Study Tabulation Model (SDTM) standard, and support additional FDA requirements to exchange textual content such as patient narratives. However, during ballot reconciliation of the Subject Data specification, it became clear that a subset of the exchange requirements were best supported as a document exchange. Currently, FDA receives patient narratives as paper forms or as MS Word or PDF documents. The goal of this CDA R2 project is to leverage the Subject Data V3 message specification as a design basis to meet the immediate need to exchange a limited data set (patient narratives) and allow implementers to leverage their existing understanding and experience with the CDA. Harmonizing the Subject Data specification with CDA R2 (and future CDA R3) will help facilitate the need for data reuse and cross reference to other pertinent trial information submitted in other HL7 V3 specifications under development: Study Participation and Study Design. |
Implementers | 1) Food and Drug Administration 2) Johnson and Johnson |
Security Risks | |
External Drivers | |
Common Names / Keywords/ Aliases | |
Lineage | |
Dependancies | CDA Release 2 (already completed) Project stemmed from #205 - CDISC Content to Message |
Project Document Repository | http://wiki.hl7.org/index.php?title=Study_Design,_Study_Participation_and_Subject_Data |
Backwards Compatibility | N/A |
External Vocabularies | |
Products | V3 Documents-Clinical (e.g. CDA) |
Joint Copyright? | |
External Pjt Collaborators | US FDA |
Realm | Realm Specific - Enter "U.S." or name of HL7 Affiliate below |
HL7 Affiliate | |
Stakeholders | Regulatory Agency |
Vendors | Pharmaceutical; Equipment |
Providers | Healthcare Institutions (hospitals, long term care, home care, mental health) |
Ballot Cycle Info | 2012 Jan Ballot Cycle Info: DSTU Ballot results: Met basic vote requirements. 22 Negatives to reconcile Document Name: HL7 Implementation Guide for CDA Release 2: Exchange of Clinical Trial Subject Data; Patient Narratives, Release 1 Ballot Code: CDAR2_IG_EXCTSD_PATNARR_R1_D1_2012JAN NIB Submitted By: Edward Tripp |
Misc Notes | April 2016: TSC approved withdrawal request. PMO archiving project. Feb 2013: TSC approved request for DSTU publication for 24 months for HL7 Implementation Guide for C® Release 2: Exchange of Clinical Trial Subject Data; Patient Narratives, Release 1 - US Realm, via tracker 2494. Test period is to Mar 15, 2015 Other SDO/Profiler: CDISC SDTM |
U.S. Govt Interest? | |
USRSC Approval | |
FMG Approval | |
ARB Approval | |
Start Date | Oct 14, 2011 |
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