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

Links

Page standards status: Informative

The following links provide important context for parties looking to make use of the Implementation Guide:

Fundamental Standards

The following are the documents for the M11 and CDISC standards that this IG is aligned with.

Link Description
M11 Template CLINICAL ELECTRONIC STRUCTURED HARMONISED PROTOCOL
(CeSHarRP)
M11 Template
Final Version
Adopted on 19 November 2025
M11 Guideline ICH HARMONISED GUIDELINE
CLINICAL ELECTRONIC STRUCTURED HARMONISED PROTOCOL
(CeSHarRP)
M11
Final Version
Adopted on 19 November 2025
M11 Technical Specification CLINICAL ELECTRONIC STRUCTURED HARMONISED PROTOCOL
(CeSHarP)
M11 TECHNICAL SPECIFICATION
Final version
Adopted on 19 November 2025
CDISC USDM Data Model Reference implementation for the CDISC/TransCelerate DDF Reference Architecture (home of the USDM model)

Phase 4, Version 4.0.0
ICH M11 Template with CPT Mappings (Section Headings ONLY) Draft mapping against the Final release of M11 Template

These links provide general information that are germane to the development of the standards.

Link Description
ICH M11 (EMA) ICH M11 guideline, protocol template and technical specifications - Scientific guideline (EMA)
ICH M11 (FDA) M11 Clinical Electronic Structured Harmonized Protocol, Center for Drug Evaluation and Research, Office of Regulatory Policy
CDISC Digital Data Flow (DDF) CDISC/TransCelerate Digital Data Flow (DDF)
HL7 Vulcan Utilizing the Digital Protocol UDP: Utilizing the Digital Protocol
CTIS Clinical Trials Information System (CTIS) assists clinical trial sponsors and other organizations involved in running clinical trials in preparing and compiling clinical trial applications and dossiers to submit for assessment by Member States in the European Union (EU) and European Economic Area (EEA).

These links are published mappings between the different standards developed as part of the development process

Link Source Target Description
CTIS Mapping USDM CTIS CDISC Mapping from USDM to EMA CTIS
SDTM Mapping USDM SDTM CDISC Mapping from USDM to CDISC SDTM Model
ClinicalTrials.gov Mapping USDM ClinicalTrials.gov CDISC Mapping from USDM to NCI ClinicalTrials.gov schema
Common Protocol Template Mapping USDM Common Protocol Template CDISC Mapping from USDM to TransCelerate Common Protocol Template (CPT)
M11 Mapping USDM M11 CDISC Mapping from USDM to ICH M11 Technical Specification
M11 to USDM to FHIR Mapping M11 and
USDM
 FHIR Three way mapping discussed in the FHIR Representation section on mapping. The versions mapped are specified in the file and will normally be the most recent.
Link Description
Evidence Based Medicine on FHIR Implementation Guide From the introduction to EBM “This implementation guide is intended for developers of systems using FHIR for data exchange of scientific knowledge and for authors of more specialized implementation guides in this domain”. As such this IG has some profiles and extensions of ResearchStudy that are a basis for further use by the UDP IG. The link here is to the build version of the EBM IG as late 2025 – this has content that is anticipated by the UDP IG but is not yet published and useable.
HL7 Vulcan Schedule of Activities Implementation Guide Readers should check for the latest version. HL7 Vulcan Schedule of Activities Implementation Guide

Introduction to FHIR

Readers who are unfamiliar with FHIR will find the following links helpful for reading this implementation guide. The links are to the first full ballot of release 6 which is a development version and as such the most current at the time of writing this IG. Equivalent pages will be found in any release of the FHIR specification.

For changes that are in development for the next version of FHIR (R6), use the Continuous Integration Build of FHIR to find related content.

Link Description
Documentation The home page for all the documentation for FHIR. There are many sections here which can be overwhelming. The links below are a selection as a starting point
FHIR Overview General overview of the basics of FHIR
Developer's introduction More detailed explanation of the mechanics of FHIR
Clinical introduction This introduction does not delve into the mechanics but does provide an explanation of why the principles of FHIR are relevant from a clinical practice perspective.
FHIR data types FHIR Resources represent their attributes using data types which may themselves have multiple attributes. This section explains the hierarchy of data types from the very simple to the complex.
Terminology - Using codes Correct use of coded values is central to transfer of data between systems. FHIR provides mechanisms for identifying the source of a code and for managing the availability of codes. This introduces the concepts of Value Sets and Code Systems and correct use of code values.
References between resources Links between resources do not work in quite the same way as links between tables in a database.
How to read resource & profile definitions The resources definitions in the specification are all defined in the same way - this section explains that pattern.
Base resource The early parts of this section discuss custom resources which are not required for this IG and which are discouraged. What is useful in this section is the discussion of identification of resource instances.
FHIR Validation The ability the validate to check that data represented in a FHIR instance is correctly formatted, uses valid codes and meets other constraints is a key benefit of FHIR. This sections explains the different validation options.