Events¶

Overview

Community Meeting (virtual)¶

(9 March 2026, virtual event, 15:00-16:00 CET)

Join us at the OpenStudyBuilder community meeting! Don't miss out on the opportunity to ask any questions to us! We can demonstrate various functionality and provide insightful answers. We can discuss on a wide range of subjects.

You can register for the event here.

Community Meeting (virtual)¶

(13 April 2026, virtual event, 15:00-16:00 CET)

Join us at the OpenStudyBuilder community meeting! Don't miss out on the opportunity to ask any questions to us! We can demonstrate various functionality and provide insightful answers. We can discuss on a wide range of subjects.

You can register for the event here.

SCDM - EMEA Conference¶

(3-5 May 2026 - Copenhagen, Denmark)

There will be a whole track about OpenStudyBuilder. Furthermore, you can watch demonstrations and discuss with us during the breaks.

Streamlining Study Setup: From Protocol to Data Collection with OpenStudyBuilder

(Monday 2026-05-04, 16:30-17:30 chaired by Ana Calduch Arques)

Additional event information like registration and program is available here.

Community Meeting (virtual)¶

(11 May 2026, virtual event, 15:00-16:00 CET)

Join us at the OpenStudyBuilder community meeting! Don't miss out on the opportunity to ask any questions to us! We can demonstrate various functionality and provide insightful answers. We can discuss on a wide range of subjects.

You can register for the event here.

CDISC + TMF Europe Interchange¶

(18-22 May 2026 - Milan, Italy)

We will be at the CDISC + TMF Europe Interchange with presentations and will be available for discussions.

Additional event information available here.

OpenStudyBuilder: Our Journey So Far and the Road Ahead

(Wednesday 14:00-14:30 by Katja Glaß and Mikkel Train)

OpenStudyBuilder is an open-source metadata and study definition repository supporting standards-based clinical trial automation. This presentation briefly reflects on key milestones and collaborations to date, including alignment with initiatives such as CDISC 360i and TransCelerate Digital Data Flow. The main focus, however, is on the road ahead: the evolving vision, strategic roadmap, and collaboration models designed to strengthen industry participation and shared ownership. Attendees will gain insight into how OpenStudyBuilder aims to further mature as a collaborative platform enabling scalable, standards-driven innovation.

From USDM to M11 and Back: OpenStudyBuilder as the Round‑Trip Engine

(Wednesday 15:00 - 15:30 by Mikkel Traun and Nicolas de Saint Jorre)

This presentation explores the integration of the Unified Study Data Model (USDM) including M11 support in OpenStudyBuilder, an open-source repository for metadata and study definitions. The USDM and M11 standards streamline the exchange of study and protocol definitions, facilitating end-to-end automation across multiple systems. OpenStudyBuilder enhances these processes with its open interfaces and native data model, offering study exports in USDM and M11 formats as JSON or HTML file. This will now include support for narrative content, enabling us to fully support M11 document content in USDM. The application also support M11 preview for easy overview supporting reviews and updates of structured M11 content managed within OpenStudyBuilder. Additionally, the API enables connectivity with other USDM-compliant systems. We will discuss the challenges faced, and highlight the opportunities presented by adopting this innovative USDM standard.

Buy one - get three! Rule-Based Naming and Standardization of SoA, SDTM, and ADaM Metadata

(Thursday 12:00 - 12:30 by Martin Gram and Julie S. Bødker)

CodeX accelerates creation of high-quality metadata when new concepts for clinical trials are not yet defined. The tool integrates with the OpenStudyBuilder API to view existing concepts to avoid redundancy and to save new concepts directly in the library. Starting from preliminary inputs from subject-matter experts, it identifies concepts by searching CDISC Biomedical Concepts, CDISC Controlled Terminology, and the NCI Thesaurus. When a match exists, the preferred name and definition are combined with business rules and SDTM domain-specific rules to auto-generate SDTM metadata, Schedule of Activities name, and ADaM PARAM/PARAMCD. If no match exists, AI agents suggest a draft name and definition based on the content in the dictionaries. By replacing complex written naming conventions with guided automation, CodeX accelerates and improves metadata creation in a process that is easy to learn and update as standards evolve. It reduces redundancy resulting in faster trial metadata setup and reduced standards maintenance.

Community Meeting (virtual)¶

(15 June 2026, virtual event, 15:00-16:00 CEST)

Join us at the OpenStudyBuilder community meeting! Don't miss out on the opportunity to ask any questions to us! We can demonstrate various functionality and provide insightful answers. We can discuss on a wide range of subjects.

You can register for the event here.

Community Meeting (virtual)¶

(13 July 2026, virtual event, 15:00-16:00 CEST)

Join us at the OpenStudyBuilder community meeting! Don't miss out on the opportunity to ask any questions to us! We can demonstrate various functionality and provide insightful answers. We can discuss on a wide range of subjects.

You can register for the event here.

PHUSE EU Connect¶

(15-18 November 2026 - Glasgow, Scotland)

We plan to be at the PHUSE EU Connect in Glasgow.