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Vulcan UDP (Utilizing the Digital Protocol): Complementing ICH M11 with an Interoperable Schedule of Activities (SoA)

 

Event Date: Tuesday, 11 February 2025

Event Time: 9:00 to 10:15 a.m. EST

 

Following the success of the first and second webinars, we're excited to announce the third in the series! Join us to learn about Vulcan’s Utilizing the Digital Protocol (UDP), an umbrella project accelerating ICH M11 and end-user value. The protocol agreed upon between the sponsor and regulator governs all aspects of a clinical trial. ICH M11/M2, CDISC, and TransCelerate are working toward a digital form of the protocol. Vulcan UDP is bringing those components together into an FHIR-based exchange to ensure the protocol's interoperability across stakeholders.

 

If you are new to Vulcan UDP:

Check out this overview video for a comprehensive background to the Vulcan UDP project and a summary of our progress.

 

During this webinar, our panelists will:

    • Give you insight into the UDP Connectathons—technical events that test development work within business processes. 
    • Discuss the Schedule of Activities (SoA) as tested during the January 2025 Connectathon, demonstrating the ability to transmit using the SoA message and render on a receiving system as a SoA table (as seen in the protocol document). 
    • Address the pathway to further digitization and the impact on business processes.

Panelists:

  • Hugh Glover, Technical Director, Vulcan
  • Mary Lynn Mercado, Global Head Protocol Delivery & US Site Head, Regulatory Writing & Submissions, Novartis 
  • Dave Iberson-Hurst, USDM Product Owner, CDISC
  • Chris Decker, President and CEO, CDISC

 

Ideal Attendees: ​

  • Anyone interested in Clinical Data Interoperability 
    • Solution Providers that utilize clinical protocol information, such as:
      • Study builders and authoring platforms 
      • Structured content management tools 
  • Sponsors and CROs involved in processes that consume protocol information, such as:
    • Protocol and Development Authoring  
    • Clinical Trial Digital and Technology Support 
    • Regulatory Operations, submissions & document management 
    • Data Manager; Innovation Manager, Infrastructure Manager, Programmers in Clinical Development
  • Health Authorities: clinical trial regulators, regulatory submission review (i.e., FDA and EMA)
     

TransCelerate webinars may be recorded in whole or in part.