Pharmaceutical Research Protocol (Vulcan UDP)
1.0.0-ballot - STU 1 - Ballot International flag

Pharmaceutical Research Protocol (Vulcan UDP), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/vulcan-udp-ig/ and changes regularly. See the Directory of published versions

Table of Contents

Page standards status: Informative
.. 0 Table of Contents
... 1 Home
... 2 02 Background
... 3 03 Best Practice
... 4 04 Use Cases
... 5 05 Protocol Preparation
... 6 06 Info Models
... 7 07 Fhir Representation
... 8 08 Bundles
... 9 09 Links
... 10 10 Credits
... 11 11 Changes
... 12 Downloads
... 13 Artifacts Summary
.... 13.1 M11 Research Study
.... 13.2 Research Study Narratives
.... 13.3 StudyDesign
.... 13.4 M11_ProtocolAmendment
.... 13.5 Narrative Elements
.... 13.6 ResearchStudyStudyAmendmentDetails
.... 13.7 ResearchStudyStudyAmendmentScopeImpact
.... 13.8 CDISC DDF Study Title Type Value Set
.... 13.9 CDISC Yes No Unknown Not Applicable Value Set
.... 13.10 M11 Identifier Type Value Set
.... 13.11 M11 Phase Value Set
.... 13.12 M11 Section Codes Value Set
.... 13.13 Narrative Elements Value Set
.... 13.14 NCI Study Role Value Set
.... 13.15 Study Amendment Country Value Set
.... 13.16 Study Amendment Reason Value Set
.... 13.17 Study Amendment Scope Enrollment Value Set
.... 13.18 Study Amendment Scope Value Set
.... 13.19 Narrative Elements Code System
.... 13.20 IGBJ Medicinal Product
.... 13.21 IGBJ Organization
.... 13.22 IGBJ Protocol Narrative 1.3 - Schedule of Activities
.... 13.23 IGBJ Protocol Narrative 2.1
.... 13.24 IGBJ Protocol Narrative 5.1
.... 13.25 IGBJ Protocol Narrative 9
.... 13.26 IGBJ Research Study with narrative