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Date Event Status
01 July 2024 Community Meeting (virtual) Scheduled
15 July 2024 OSB-Hub & OSB-Trail-ControlledTerminology Scheduled
10 October 2024 DDF in Action Day - Copenhagen, Denmark & New Jersey, US Planned
10 October 2024 PHUSE SDE - Copenhagen, Denmark Planned
22 October 2024 COSA Workshop - Phoenix/Scottsdale, US Scheduled
23-24 October 2024 CDISC US Interchange - Phoenix/Scottsdale, US Scheduled
10-13 November 2024 PHUSE EU Connect - Strasbourg, France Planned
22 November 2024 BVMA - Munic, Germany Scheduled

Community Meeting (virtual)

(1 July 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.

OSB-Hub & OSB-Trail-ControlledTerminology

(15 July 2024, 15:00-15:50 CEST, virtual event)

Welcome to our OSB-Hub where we want to introduce the OSB-Trail-ControlledTerminology community team! We hope you would like to join the collaboration!

You find additional information on our wiki!

The invite ics file can be downloaded here.

DDF in Action Day - Copenhagen, Denmark & New Jersey, US

(10 October 2024)

We will be at the DDF in Action Day in Copenhagen and New Jersey. We likely present a poster at each location.

PHUSE SDE - Copenhagen, Denmark

(10 October 2024)

There will be OpenStudyBuilder representatives at the event.

COSA Workshop at CDISC US Interchange

(22 October 2024 - Phoenix/Scottsdale, US)

COSA OpenStudyBuilder workshop - Use OpenStudyBuilder to drive EDC setup - a COSA Workshop

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.

Event information and registration is available here.

CDISC US Interchange

(23-24 October 2024 - Phoenix/Scottsdale, US)

We will be at the CDISC Interchange with a presentation and are also planning for a workshop (planning ongoing).

Schedule of Activities in OpenStudyBuilder

by Mikkel Traun, Novo Nordisk

This presentation demonstrate how OpenStudyBuilder operates across various standard levels to define the Schedule of Activities (SoA) as part of a structured study specification, catering to distinct study purposes:

  • Protocol SoA: High level SoA in protocol, main purpose is for the investigator and site staff to get an overview of the operational schedule.
  • Detailed SoA: Specifying the semantic data observations to be collected in the study – but not specific to representation in ADaM, SDTM or data collection; Will be part of protocol and appendixes or other supplementary documents.
  • Operational SoA: Data specification to support data collection specification; Will also be related to specific ADaM PARAM/PARAMCD for collected data and thereby used to specify the data needed for analysis.
  • Data Capture / Collection Specification: EDC information related to the SoA – i.e., how data is to be collected in the study and when, what is pre-set, what is collected and how.

The Schedule of Activities at the different levels are a major result when working with biomedical concepts and for this is integrated in the data model linked to the corresponding biomedical concept definitions in OpenStudyBuilder library module. This way and end-to-end connectivity and study setup automation is enabled.

The OpenStudyBuilder is developed as an outcome from the CDISC 360 project and shared as open source under COSA aiming for end-to-end automations from protocol to TLFs. The solution consists of a Study Builder Application connected to a Metadata Repository holding data standards and a Study Definition Repository with study specifications.

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.