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Date Event Status
23 April 2024 COSA Workshop at CDISC EU Interchange - Berlin, Germany Scheduled
24-25 April 2024 CDISC EU Interchange - Berlin, Germany Scheduled
27 June 2024 PHUSE SDE - Heidelberg, Germany Scheduled
10 October 2024 PHUSE SDE - Copenhagen, Denmark Planned
10-13 November 2024 PHUSE EU Connect - Strasbourg, France Planned
22 November 2024 BVMA - Munic, Germany Scheduled

COSA Workshop at CDISC EU Interchange

Use OpenStudyBuilder to drive EDC setup - a COSA Workshop

(23 April 2024 09:00 - 16:00 - Berlin, Germany)

The landscape of system integrations within our industry often poses significant challenges despite the existence of established data exchange standards such as CDASH and ODM as well as the upcoming Biomedical Concepts and USDM, and others. Many tools, however, tend to support only their native formats or a limited selection of standards using custom extensions. This workshop aims to delve into these challenges and explore the vast opportunities available when integrating systems effectively.

The workshop will primarily concentrate on the integration aspects of EDC (Electronic Data Capture) systems with OpenStudyBuilder, which boasts highly accessible interfaces through APIs and/or via ODM.XML file based integrations. Participants will gain insights into what currently would work and identify existing gaps, considering each system coming along with their own operational data model.

We will start by explaining the OpenStudyBuilder vision around the end to end process with the illustration of the OSB Biomedical Concept (OSB BC).

This will illustrate the Library and the Studies areas of the OpenStudyBuilder, and the reason for having every CTs, models and dictionaries connected to the metadata of our studies.

We will here present the CRF module in the Library and explain the specification around the Study level, throught the use of the OSB BC.

Then, we will split into different breakout groups with the following focus:

  • Breakout 1 - EDC API based Integration: Working with standard CRFs (Case Report Forms), study SoA (Schedule of Activities) and vendor extensions in OpenStudyBuilder connecting to the EDC tools for EDC setup with bidirectional API based connections
  • Breakout 2 - EDC ODM.XML based Integrations: Same as above, but focused on file based ODM.XML integrations.

The integrations include study design definitions, reference and configuration of standard collection forms as well as specification of study specific forms. This will include use of Biomedical Concepts linking the data collection structure to a semantic definition and representation in e.g. SDTM. This will be illustrated from the ongoing data model in OSB, and how this model is related to the CDISC COSMoS BC model and USDM.

Registration is available here.

CDISC EU Interchange

(24-25 April 2024 - Berlin, Germany)

We will be to be at the CDISC EU Interchange and there is one presentation about the OpenStudyBuilder. Additionally we will be at the COSA booth and perform various demonstrations. Please use the chance to talk to us!

From OpenStudyBuilder to the Digital Data Flow- USDM Format

(25 April 2024 14:40 - 15:00 by Maurizio Mazzei, Neo4j & Nicolas De Saint Jorre, Novo Nordisk)

USDM stands for Unified Study Data Model, which is a standardized data model developed by the Clinical Data Interchange Standards Consortium (CDISC) to facilitate the exchange, submission, and archiving of clinical research data. The USDM is designed to be a comprehensive and flexible model that can accommodate a wide range of study designs, data types, and data collection methods.

On the other side, the OpenStudyBuilder is an open-source software tool designed to simplify the process of creating and managing clinical study metadata.

By generating metadata in the USDM format, the OpenStudyBuilder simplifies the process of organizing and documenting clinical study data. The USDM standardized format ensures that data is collected consistently across all study sites and can be easily analysed and compared across different studies.

We plan to run a live demonstration starting from a defined study and illustrate how those metadata can be converted and seen in the USDM format as a JSON file.

By using the USDM in conjunction with other CDISC standards inside the OpenStudyBuilder, researchers can ensure that clinical research data is collected, analysed, and reported in a consistent and standardized manner. This makes it easier to share and compare data across different studies and study sites, which can help to improve the quality and efficiency of clinical research.

Registration is available here.

PHUSE SDE - Heidelberg, Germany

(27 June 2024)

Revolutionizing Clinical Trials: The Impact of OpenStudyBuilder on Automation and Insights

by Katja GlaƟ, Katja Glass Consutling

OpenStudyBuilder, an open-source metadata and study definition repository, is revolutionizing the landscape of clinical trials by enabling end-to-end automation, from protocol generation to report creation. This presentation will provide an in-depth exploration of the current capabilities of OpenStudyBuilder, with a focus on its available and upcoming downstream tools. These include a Word add-in for protocol generation, standard utilities such as an R package for study and standard metadata download, and integrations with EDC and ePRO systems. Additionally, we will delve into how dashboards can offer insightful knowledge.

Event information is available here.

PHUSE SDE - Copenhagen, Denmark

(10 October 2024)

We plan to submit an abstract for the PHUSE SDE Copenhagen in Denmark. There will be OpenStudyBuilder representatives at the event.

PHUSE EU Connect

(10-13 November 2024 - Strasbourg, France)

We plan to be at the PhUSE EU Connect where we will submit various presentations.

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.