Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2 International flag

Clinical Study Protocol, 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-ballot2 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 Acknowledgements
... 3 Background
... 4 Best Practice
... 5 Bundles
... 6 Changes
... 7 Crossreferences
... 8 Downloads
... 9 Fhir Representation
... 10 Info Models
... 11 Licenses
... 12 Links
... 13 Protocol Preparation
... 14 Terminology
... 15 Use Cases
... 16 Artifacts Summary
.... 16.1 M11_Approval
.... 16.2 M11_ConfidentialityStatement
.... 16.3 Research Study Narratives
.... 16.4 M11 Research Study Profile
.... 16.5 M11 Research Study Extension
.... 16.6 Narrative Elements
.... 16.7 M11_ProtocolAmendment
.... 16.8 M11_AmendmentDetails
.... 16.9 M11_AmendmentScopeImpact
.... 16.10 Fragment of NCIT Code System
.... 16.11 ICH M11 Amendment Details Statement Value Set Terminology
.... 16.12 ICH M11 Amendment Scope Enrollment Description Value Set Terminology
.... 16.13 ICH M11 Trial Blinding Role Value Set Terminology
.... 16.14 ICH M11 Study Amendment Country Value Set
.... 16.15 ICH M11 Trial Phase Value Set Terminology
.... 16.16 ICH M11 Reason for Amendment Value Set Terminology
.... 16.17 ICH M11 Amendment Scope Value Set Terminology
.... 16.18 ICH M11 No Yes Value Set Terminology
.... 16.19 UDP Address Purpose Type Value Set
.... 16.20 UDP Identifier Type Value Set
.... 16.21 UDP Narrative Elements Value Set using NCIT codes to create a FHIR value set.
.... 16.22 UDP Party Role Type Value Set
.... 16.23 UDP Related Artifact Type Value Set
.... 16.24 UDP Section Codes Value Set
.... 16.25 UDP Study Title Type Value Set
.... 16.26 START HERE: Exemplar Research Study with narrative
.... 16.27 Exemplar Protocol Narrative
.... 16.28 Exemplar Protocol Narrative 2.1
.... 16.29 Exemplar Medicinal Product
.... 16.30 Exemplar CoSponsor Organization
.... 16.31 Exemplar Devices Organization
.... 16.32 Exemplar Local Sponsor Organization
.... 16.33 Exemplar Regulating Authority (ERA)
.... 16.34 Exemplar Sponsor Organization
.... 16.35 Exemplar CoSponsor Practitioner
.... 16.36 Exemplar Local Sponsor Practitioner
.... 16.37 Exemplar Sponsor Expert Medical Practitioner
.... 16.38 Exemplar Sponsor Practitioner
.... 16.39 Current amendments details
.... 16.40 JPMA0001 Inclusion/Exclusion Narrative
.... 16.41 Japanese Protocol from Vulcan UDP Eligibility Criteria
.... 16.42 JPMA Organization
.... 16.43 JPMA0001 Provided Example - English Language
.... 16.44 JPMA0001 Provided Example - Japanese Language
.... 16.45 IGBJ Research Study with narrative as Single Composition
.... 16.46 Example Narrative Single Composition
.... 16.47 Narrative Author Organization
.... 16.48 IGBJ Research Study with Composition Section for Each M11 Section
.... 16.49 Example Narrative Composition per M11 Section - Section 1
.... 16.50 Example Narrative Composition per M11 Section - Section 2
.... 16.51 Example Narrative Composition per M11 Section - Section 3
.... 16.52 IGBJ Research Study with composition for each M11 narrative section
.... 16.53 Example Narrative Single Composition with a Section for Each M11 Section
.... 16.54 IGBJ Research Study with complex narrative
.... 16.55 Example Narrative Complex - Other Patterns and Non M11 Content Suggestion
.... 16.56 StudyEligibilityCriteria: Eligibility Criteria for DIBASY Trial