Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2

Clinical Study Protocol - Downloaded Version 1.0.0-ballot2 See the Directory of published versions

## Crossreferences

Page standards status: Informative | Highlight text changes?

### 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.

IG | Package | FHIR | Comment
--- | --- | --- | ---
Clinical Study Protocol | hl7.fhir.uv.clinical-study-protocol#1.0.0-ballot2 | R6 |
HL7 Terminology (THO) | hl7.terminology.r5#7.1.0 | R5 | Automatically added as a dependency - all IGs depend on HL7 Terminology
FHIR Extensions Pack | hl7.fhir.uv.extensions.r5#5.2.0 | R5 |
FHIR Tooling Extensions IG | hl7.fhir.uv.tools.r5#1.1.2 | R5 | for example references

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)