Section 1a: Clinical Document Architecture (CDA®)
Section 3: Implementation Guides
HL7 Implementation Guide for CDA® Release 2: Exchange of Clinical Trial Subject Data; Patient Narratives, Release 1 - US Realm
DESCRIPTION
The scope of this 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.
ALTERNATIVE NAMES
HL7 Implementation Guide for CDA® Release 2: Exchange of Clinical Trial Subject Data; Patient Narratives, Release 1 - US Realm may also go by the following names or acronyms:
"HL7 Implementation Guide for CDA Release 2: Exchange of Clinical Trial Subject Data; Patient Narratives, Release 1"
TARGETS
- Regulatory Agency
- Pharmaceutical Vendors
BENEFITS
- Facilitates patient narrative data reuse and cross reference to other pertinent clinical trial information
DEVELOPMENT BACKGROUND
This implementation guide describes how to leverage the HL7 Clinical Document Architecture (CDA) standard for the Exchange of Clinical Trial Subject Data: Patient Narratives.
RELATED DOCUMENTS
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HL7 Implementation Guide for CDA® Release 2: Exchange of Clinical Trial Subject Data; Patient Narratives, Release 1 - US Realm |
TOPIC
- Regulated Studies
BALLOT TYPE
- DSTU
STATUS DATE
2016-04-11RESPONSIBLE WORK GROUPS
STAKEHOLDERS
- Pharmaceutical Vendors
- Regulatory Agency
FAMILY
- CDA
CURRENT STATE
- Stable
REALM
- US Realm