OpenStudyBuilder #22 – Release 0.11.2, OSB Trail Controlled Terminology & Events

The OpenStudyBuilder team is very busy again. We managed a release cycle of four weeks which showcases that the agile approach is working very well. Our OpenStudyBuilder Trail for Controlled Terminology continues. Here we would like to share some progress. Additionally, we prepare for various events as there are many coming in October and November!

Release 0.11.2

The OpenStudyBuilder team is proud to announce that we have successfully reduced our release cycle time to four weeks, showcasing the effectiveness of our agile approach. This means you can now expect quicker releases. While there is still some delay between the internal Novo Nordisk release and the open-source release due to external processes like testing and updating the public sandbox environment, alignment is generally achieved.

In release 0.11.2, we have implemented various background enhancements, including quality improvements driven by increased automated test coverage. Additionally, the import scripts for activity content have been improved. The process for creating new visit types in the Library has been simplified, and we have removed restrictions on which epochs a visit type can belong to. Continuous feedback and testing have allowed us to resolve numerous bugs, such as enabling spaces in search fields, correcting version links, and more.

As a new feature, it is now possible to perform global system announcements within the “System announcement” screen. Administrators can use the location “<osb-url>/administration/announcements” to trigger announcements to all users. This feature is particularly useful for informing users about maintenance times, new features, and other important updates.

Users will see the announcement prominently displayed at the top of their screen and can dismiss it once they have acknowledged the information.

OSB Trail Controlled Terminology (CT)

Next to the core OpenStudyBuilder team, a COSA community has been established to support the broader utilization of OpenStudyBuilder. While we review current OpenStudyBuilder processes and documentation related to CDISC and sponsor controlled terminology, our team is also focused on creating a more user-friendly interface for loading content, moving beyond the existing script-based approach. We use Slack to discuss content, share our plans, and provide status updates. Feel free to follow the #osb-trail-controlledterminology channel in the COSA Community Slack (join here).

Updates on CT Management

The controlled terminology management at Novo Nordisk is currently operating on a legacy system, but it is planned to be replaced by OpenStudyBuilder by the end of this year or early next year. Extensive migration activities are underway internally. Additionally, the trail has delved into the details, and we have had productive discussions with one of the Controlled Terminology (CT) developers.

As a result of these efforts, we can anticipate significant changes. Firstly, the underlying data model will undergo a major refactoring. The original model deviated from the CDISC model, which proved impractical. This is complicated by the fact that there are inconsistencies in the CDISC Controlled Terminology (CT) causing troubles. We just recently reported these to the CDISC organization. For instance, term descriptions differ across various catalogs, such as the GLOSSARY CT and SDTM CT.

The upload scripts for loading controlled terminology into OpenStudyBuilder have undergone numerous enhancements and fixes. Consequently, the script has become more complex and slower than necessary. To address this, there is the plan to rewrite the script to simplify it and improve performance. This may also necessitate minor updates to the import files, particularly when uploading sponsor-specific controlled terminology. All changes will be thoroughly documented to outline the necessary updates for the new process. We understand that some OpenStudyBuilder implementations have already been tested and integrated, so existing work will need to be adjusted. However, we anticipate minimal changes for uploading sponsor-controlled terminology and will update our documentation to support these processes.

User Interface for CT Uploads

An exciting community project is underway to develop a user interface for loading CDISC and sponsor-controlled terminology into OpenStudyBuilder. The draft specifications are available for review and feedback in our Slack space. We encourage you to check them out and share your comments. A key feature of this project is the ability to easily upload sponsor-controlled terminology. We aim to support various formats, including JSON, CSV, XLS, and XLSX. To demonstrate the functionality, we will provide a pre-specified structure along with examples.

The second aspect involves uploading CDISC Controlled Terminology directly from the CDISC library. The user interface will allow users to input their CDISC library API key and display the connection status. Once connected, users can search for available packages, such as specific SDTM CT versions. These packages can then be selected for upload to the OpenStudyBuilder solution, automatically triggering all necessary steps.

There is a lot of excitement surrounding this user interface, and it has the potential to become a core component embedded directly into the native solution or as an add-on. Stay tuned for future updates, and if you would like to get involved, join the Slack channel and share your thoughts!

Summary

We are excited to announce several significant updates for the management of controlled terminology:

• Data Model Updates: Major refactoring to align more closely with the CDISC model.
• Enhanced Upload Script: Simplified and optimized for better performance.
• Community-Driven User Interface: A new, intuitive interface for uploading CDISC packages and sponsor-controlled terminology, driven by community.

Stay tuned for these improvements, which aim to streamline and enhance your experience with OpenStudyBuilder.

Events

In addition to the ongoing efforts of our OpenStudyBuilder team and community, we are excited to participate in various upcoming events where you can learn more about our open-source solution, engage in discussions, and provide valuable feedback. These events offer a great opportunity to connect with our team, explore the latest developments, and share your insights.

On November 10th, 2024, we had the privilege of participating in two concurrent events. Given the strong connection between OpenStudyBuilder and the TransCelerate Digital Data Flow (DDF) project, Camilla Kehler presented on the “Adoption of DDF @Novo Nordisk” during the DDF in Action Day. We can export studies using the new USDM standard, we started implementing the M11 format, and we work with Biomedical Concepts, all while keeping the end-to-end data flow in mind. Our poster showcased the current state of USDM generation, reflecting our commitment to advancing in the digital data flow initiative.

Additionally, we participated in the PHUSE Single Day Event in Copenhagen, where Anja Lundgreen and Antoni Palusinski presented a poster showcasing our solution. Engaging with colleagues from the industry is always a pleasure, and the OpenStudyBuilder continues to garner significant interest. We received numerous questions and valuable feedback. One key takeaway is the need for clarification regarding the utilization of Neo4j within the OpenStudyBuilder, particularly concerning licensing, as it is the only commercial component required. Stay tuned for follow-up communications on this topic.

Remember, we also host regular community meetings, with the next sessions scheduled for November 4th and December 2nd. These meetings are open to everyone and provide an excellent opportunity to ask questions, offer suggestions, and engage in discussions. We can delve into specific topics related to OpenStudyBuilder, including live demonstrations and in-depth explorations of its features.

Two major conferences are on the horizon. The CDISC US Interchange will take place in Phoenix, Scottsdale, where we will conduct a workshop on EDC integrations. This session will showcase the current status of OpenStudyBuilder and explore how we can integrate and automate EDC generation, particularly with the use of Biomedical Concepts.

In addition to the workshop, Mikkel Traun will deliver a presentation on “Schedule of Activities in OpenStudyBuilder.” He will also be available during the breaks to answer any questions you may have. We encourage you to take this opportunity to engage with him and gain deeper insights into the solution.

The PHUSE EU Connect will be held in Strasbourg, France, this November. This event provides a fantastic opportunity to connect with key members of our OpenStudyBuilder team, including Mikkel Traun, Nicolas de Saint Jorre, J?rgen Mangor Iversen from Novo Nordisk, and Marius Conjeaud from Neo4j. Don't miss the chance to engage with our experts.

We will present a poster on OpenStudyBuilder and deliver a presentation titled “Leveraging the USDM Standard in OpenStudyBuilder for Enhanced Data Exchange.” Additionally, we are excited to discuss our planned Veeva EDC integration through their "SDS" format, specifically focusing on “Mapping a Veeva SDS Specification to ODM-XML.” There will also be numerous other presentations covering topics such as Digital Data Flow and the USDM format, all of which are highly relevant to OpenStudyBuilder.

You can also visit our events page to stay updated on where we will be presenting and participating. We look forward to meeting you at these events and hearing your valuable feedback. Engaging with our community is crucial to the continuous improvement and success of OpenStudyBuilder. Thank you for your ongoing support, and we hope to see you soon!

OpenStudyBuilder Status

The accompanying visualization provides a snapshot of the current state of the end-to-end implementation. It's important to note that the components already incorporated are subject to ongoing improvements. Furthermore, elements of subsequent processes may already be operational, thanks to the standardization and interlinking of information. This dynamic nature of development ensures that OpenStudyBuilder remains responsive to evolving needs and continues to deliver enhanced functionality.

Get the software

There are three ways how you can get the OpenStudyBuilder software. You can download the source from GitLab and install it locally, on a server or in the cloud on your own. You can register for the Sandbox and experience the OpenStudyBuilder on the public shared environment. And you can also get a dedicated hosted environment (associated with costs) by contacting Neo4j.

Getting Started

For additional information about the OpenStudyBuilder, please visit the?project homepage. There you can find a valuable list of resources, including a detailed 30 minute demonstration video. We also provide various guides to dive into specific topics.

The GitLab repository contains installation instruction for the complete OpenStudyBuilder solution or single components. Various scripts are available, for example to import standard through the CDISC library. If you are interested in the concrete models and concepts the OpenStudyBuilder uses, you can browse them there as well.

Please follow our newsletter here in LinkedIn, join us in?Slack, write a message to the OpenStudyBuilder team via mail [email protected] or contact us at conferences and similar! In case of issues, you can also use?GitLab Issues?to report these. If you would like to share your experiences and feedback, please fill out our survey or send a message!?

We are looking forward to collaborations.