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

Crossreferences

Page standards status: Informative

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Related IGs

This FHIR implementation guide has the following relationships with other FHIR implementation guides:

Vulcan Schedule of Activities (SoA) - Originated in PHUSE and later transitioned into a Vulcan project, this IG provides a FHIR representation of the Schedule of Activities, a crucial component of most protocols. The use case focuses on maintaining an unambiguous definition of the Schedule of Activities during study execution, which can be utilized to generate a detailed care plan for specific patients.

Evidence Based Medicine (EBM) - EBM is a project within HL7 also working on practices for leveraging FHIR for exchange of protocol information. While Vulcan Utilizing the Digital Protocol (UDP) project focuses on the design, conduct, and generation of data generally to support clinical development, EBM aims at a systematic approach to clinical decision-making that integrates the best available research evidence with clinical expertise and patient values. It involves systematically finding, appraising, and applying the results of well-designed clinical research, particularly randomized controlled trials (RCTs) and systematic reviews, to inform clinical decisions and optimize patient outcomes. Together, they enable a learning health system by utilizing digital protocol standards to facilitate research and apply systematic evidence. Vulcan UDP leverages practices and learnings from EBM.

Conformance

Id	Expectation	Rule
	SHOULD  SHALL
§1	SHOULD	At least one of approvalDate or signatureUrl SHOULD be populated
§2	SHALL	Attributes type and section.code SHALL be used to specify the structure in accordance with M11
§3	SHALL	identifier - there SHALL be a value assigned by the Sponsor value
§4	SHOULD	identifier - there SHOULD be a value assigned by the Regulator
§5	SHALL	identifier.type - SHALL be populated so that the different identifiers required by M11 can be recognised
§6	SHALL	title - M11 requirement, SHALL be present
§7	SHALL	m11-research-study - M11 requirement, extension SHALL be populated
§8	SHALL	m11-protocol-amendment - M11 requirement, extension SHALL be populated
§9	SHALL	phase - M11 requirement, SHALL be present
§10	SHALL	associatedParty.party.reference - M11 requirement, SHALL have a Sponsor name and address
§11	SHALL	m11-approval - M11 requirement, SHALL have either a date or location for approval of protocol
§12	SHALL	Both originalProtocol and versionDate SHALL be populated

Cross-Version Analysis

Global Profiles

There are no Global profiles defined

IG Dependencies

This IG Contains the following dependencies on other IGs.

Package hl7.fhir.uv.extensions.r5#5.2.0 This IG defines the global extensions - the ones defined for everyone. These extensions are always in scope wherever FHIR is being used (built Mon, Feb 10, 2025 21:45+1100+11:00)

Package hl7.fhir.uv.tools.r5#1.1.2 This IG defines the extensions that the tools use internally. Some of these extensions are content that are being evaluated for elevation into the main spec, and others are tooling concerns (built Tue, Mar 24, 2026 11:13+1100+11:00)