CDISC USDM Protocol Exchange
Explore structured clinical trial protocols
Access and learn from real-world protocol data — built for reuse, automation, and interoperability.
Built on the CDISC USDM standard
Why structured protocols matter
Digital protocols power faster, more automated trials
Digital protocols are key to faster, more efficient and more automated clinical trials.
Improve design
Reduce ambiguity and improve protocol quality from the first draft.
Streamline execution
Enable faster downstream activities with machine-readable definitions.
Remove friction
Eliminate manual rework across systems and organizations.
What this is
A shared repository of structured CDISC USDM protocols
Protocol Explorer provides access to a shared repository of structured, USDM-based clinical trial protocols. Anyone can browse and learn from the available protocols. Users who want to add and manage their own USDM-formatted protocols can create an account and contribute to the repository.
Browse the repositorySchedule of activities
| Activity | V1 | V2 | V3 |
|---|---|---|---|
| Informed consent | — | — | |
| Vital signs | |||
| Laboratory sampling | — |
Product behavior
How teams use Protocol Explorer
Explore
Browse structured protocol data.
Understand
See real study design.
Reuse
Use existing protocols as a foundation.
Accelerate
Move faster across organizations.
Built on open standards
A foundation the industry already trusts
CDISC USDM Standard
CDISC standards are the common language of clinical research. USDM represents the next generation of standards, enabling seamless interoperability across the industry.
Learn MoreTransCelerate DDF
A TransCelerate BioPharma initiative to advance drug development by enabling clinical trial protocol digitalization. It uses the Unified Study Definitions Model (USDM) to move the industry from a document-centric to a data-centric approach.
Learn MoreICH M11
An international standard for the structure, content, and electronic exchange of clinical trial protocols. ICH M11 introduces a harmonized protocol template and technical specification — complementing the USDM standard as a foundation for digital, machine-readable study designs.
Learn MoreStart exploring real-world USDM protocols
Browsing is open to everyone. Sign in to contribute and manage your own USDM-formatted protocols.
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