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Section 1e: Version 3 (V3)
Section 2: Clinical and Administrative Domains

HL7 Version 3 Standard: Study Design: Structured Document, Release 1 - US Realm

DESCRIPTION

A structured document capable of exchanging the human-readable text (i.e. the traditional text-based protocol document currently provided as either a paper document, or a pdf file) in addition to structured protocol data. Some of the requirements for this structured document cannot be met by CDA and therefore this will be a unique structure developed as a sibling to CDA

ALTERNATIVE NAMES

HL7 Version 3 Standard: Study Design: Structured Document, Release 1 - US Realm may also go by the following names or acronyms:

"HL7 V3 Standard: Study Design: Structured Document, R1"

TARGETS

  • FDA
  • Various Pharmaceutical companies

BENEFITS

  • Provides a means of communicating a clinical research study protocol in both human readable form and processable data for the design items of the protocol

IMPLEMENTATIONS/CASE STUDIES

  • FDA
  • Various Pharmaceutical companies

RELATED DOCUMENTS

HL7 Version 3 Standard: Study Design: Structured Document, Release 1 - US Realm

TOPIC

  • Regulated Studies

BALLOT TYPE

  • DSTU

STATUS DATE

2016-03-16

RESPONSIBLE WORK GROUP

Biomedical Research and Regulation

FAMILY

  • V3

CURRENT STATE

  • Retired

REALM

  • US Realm