Events¶

Overview

PHUSE EU Connect¶

(10-13 November 2024 - Strasbourg, France)

We will be at the PhUSE EU Connect. Please come to the Novo Nordisk or CDISC Open Source Alliance booth to catch up with us. We are also happy to participate in the following events:

Poster - Status and news in OpenStudyBuilder

by Mikkel Traun, Novo Nordisk

The OpenStudyBuilder is an open-source project for clinical study specifications. This tool is a new approach for working with studies that once fully implemented will drive end-to-end consistency and more efficient processes - all the way from protocol development and CRF design - to creation of datasets, analysis, reporting, submission to health authorities and public disclosure of study information.This poster will present our current status and capabilities added to StudyBuilder this year.

Presentation - Leveraging the USDM Standard in OpenStudyBuilder for Enhanced Data Exchange

by Marius Conjeaud, Neo4j and Nicolas de Saint Jorre, Novo Nordisk

Explore the integration of the Unified Study Data Model (USDM) in OpenStudyBuilder, an open- source metadata and study definition repository. Developed by CDISC, USDM aims to streamline the exchange of study definitions and enable end-to-end automation across multiple systems. OpenStudyBuilder supports these processes and facilitates system integrations with its open interfaces and native graph-based data model. Beyond its native exports, OpenStudyBuilder also offers a study export in USDM format as a JSON file, enhancing connectivity with other USDM-compliant systems. This presentation delves into the data collection and transformation process, the challenges encountered, and the opportunities presented by this innovative standard.

Related Presentation - Digital Data Flow: Achieving Protocol Digitalization and Clinical Research Interoperability through Multi-stakeholder Collaboration

by Mikkel Traun, Novo Nordisk on behalf of TransCelerate

Digitalizing clinical protocol information can streamline study start-up, enable analytics-assisted study design and feasibility, and support more routine use of point-of-care data for research. Digital Data Flow (DDF) has supported the CDISC efforts to develop a foundational data model, the Unified Study Definitions Model (USDM), and has developed an open-source reference implementation, the Study Definitions Repository (SDR) to digitalize the clinical protocol and achieve interoperability between clinical trial systems.This session focuses on how industry stakeholders can make real the application of DDF for clinical protocol digitalization for your organization. The presentation will sit alongside presentations, "ICH M11 Clinical electronic Structure Harmonized Protocol (CeSHarP) and CDISC: Making the Electronic Protocol a reality" and "The TransCelerate / CDISC Digital Data Flow Project: Practical Electronic Study Designs" to set the stage on how the DDF project and the ICH M11 work will come together in the future as an important industry initiative.

Related Presentation - Mapping a Veeva SDS specification to ODM-XML

by Jørgen Mangor Iversen, Novo Nordisk

As Veeva EDC grows increasingly popular across the industry, more and more sponsors become acquainted with its Study Design Specification (SDS) document. The focus here is on what information is inside the SDS and how it is related to the CDISC ODM-XML standard and serves as inspiration on how to map an SDS to a generic ODM-XML. Topics covered include the level of transformations, a discussion of internal and external keys, data types, vendor specific data, edit checks, and ODM-XML data not found in the SDS. The scope is solely the definitions of library CRF forms and does not include any other data that may be stored in ODM-XML format.

BVMA (German Organization)¶

(22 November 2024 - Munic, Germany)

Katja will speak at the German organization "Bundesverband Medizinischer Auftragsinstitute e.V." about an introduction to the OpenStudyBuilder, and the oppotunities it provides as an open source project.

Additional information is available here.

Community Meeting (virtual)¶

(2 December 2024, virtual event)

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.

ACDM - Prague¶

(3-4 March 2025 - Prague, Czech Republic)

We submitted an abstract for the ACDM (Association for Clinical Data Management) conference in Prague.

DIA EU¶

(18-20 March 2025 - Basel, Switzerland)

We submitted an abstract for the DIA EU (Drug Information Association) conference in Prague.

CDISC EU Interchange¶

(14-15 May 2025 - Geneva, Switzerland)

We will very likely be available at the CDISC EU Interchange conference in Geneva.