Utilizing the Digital Protocol (UDP)

Project Information

Status:

Active

Page Last Updated:

14 August, 2025

Project Introduction

Utilizing the Digital Protocol (UDP)

The UDP project is a collaborative effort between Vulcan, CDISC, and TransCelerate, working together with global regulatory stakeholders.

Its mission is to modernize clinical trial protocols by creating a machine-processable format using FHIR (Fast Healthcare Interoperability Resources), aligned with the ICH M11 Guideline, Template, and Technical Specification.

Protocols currently live in static PDFs and Word documents. UDP transforms them into structured, interoperable data that can be exchanged seamlessly between sponsors, regulators, research sites, and healthcare systems, unlocking opportunities for automation, faster reviews, and global harmonization.

UDP

Project Resources

Confluence

Project workspace with meeting notes, documentation, and collaboration materials.

FHIR IG

The evolving technical specification that defines how FHIR is used for this project.

SharePoint Resources

Central repository for project artifacts, reference materials, and shared files.

What is a clinical trial protocol?

The protocol is the blueprint for a clinical trial, it drives every detail of how a study is conducted. It sets out the background, research questions, objectives, design, methodology, statistical plan, and ethical considerations, following the ICH Guidelines for Good Clinical Practice (GCP) E6.

About ICH M11

ICH M11 is a consensus-driven standard developed by global regulators and industry experts to harmonize clinical trial protocols. It provides a structured, electronic protocol template (CeSHarP) and technical specification designed for consistent, regulator-ready submissions worldwide.

This standard underpins UDP’s work, forming the foundation for a FHIR-based Implementation Guide and aligned Information Model and Terminology.

Learn More on the ICH Website

Get Involved

UDP is built through open collaboration, and your expertise can help shape the future of digital protocols. Join our webinars and connectathons to contribute, test, and learn.