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

This page is part of the Pharmaceutical Clinical Trial Protocols (v1.0.0-ballot: STU 1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v6.0.0. No current official version has been published yet. For a full list of available versions, 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