OpenStudyBuilder #26 – Release 0.14 and Short-Term-Roadmap

OpenStudyBuilder – Release 0.14

We’re excited to announce the release of OpenStudyBuilder version 0.14, packed with new features, enhancements, and fixes to further enhance the protocol setup and utilization and to support the end-to-end process further. A huge thank you to the developers for these improvements!

USDM & ICH M11

The Unified Study Definitions Model (USDM) in its JSON format is highly structured and ideal for processing. As we advance toward protocol automation, USDM is expected to play a key role in supporting the new ICH M11 protocol standard. One approach is to leverage the USDM format to dynamically generate an M11 protocol.

To facilitate this, a new ICH M11 view has been implemented, allowing users to visualize the USDM file in an M11 format. This view also includes functionality to toggle instructions, suggestions and fields, making it easier to navigate and customize protocol content as needed.

At this stage, only a limited set of items are populated, but ongoing updates will expand coverage as the project progresses. Additionally, OpenStudyBuilder now supports USDM version 3.6, ensuring alignment with the latest data model updates. Further technical enhancements at the API level are planned for future releases to improve processing and integration capabilities.

SoA Updates

A core part of protocol development is defining and managing the Schedule of Activities (SoA), which requires planning, grouping, and unluckily also continuous updates. As the protocol evolves, modifications to the SoA become necessary, and ensuring a smooth and efficient update process is essential. To streamline this workflow, several new features have been introduced to enhance usability and flexibility.

Users can now edit, add, exchange, or remove activities directly within the Detailed SoA view. This is done by simply clicking on the three-dot menu next to an activity, allowing for seamless modifications without navigating away from the main view.

In addition to individual activity edits, OpenStudyBuilder now supports bulk editing of activities. This feature allows users to assign the same visits to multiple activities at once, modify SoA groups for multiple activities and batch remove multiple activities in a single action.

Additional enhancements are on the roadmap, so working with the SoA will become more and more flexible and user-friendly!

NeoDash Additions

This update brings several enhancements to the NeoDash dashboards. Since all dashboards are already linked to OpenStudyBuilder, the "OpenStudyBuilder Activity Library Dashboard" has been renamed to "Activity Library Dashboard" for a more concise and intuitive experience.

Additionally, two new dashboards have been introduced:

The Activity Metadata Check dashboard helps identify inconsistencies such as missing activity items or incorrect groupings. To support different approaches, it offers two search methods: a top-down search, which allows users to drill down into activity items for a detailed view, and a bottom-up search, which ensures that activities have the correct items grouped to them.

The Pre-Define Dashboard offers insight into the early development progress of pre-define.xml generation, based on the Schedule of Activities and Operational Data Specification. As this functionality continues to evolve, the dashboard provides a first look at how the study metadata will likely come to utilize further downstream. It requires a master SDTM model to be loaded and a study with a defined operational Schedule of Activities. Additionally, the corresponding activity instances must be linked to the appropriate SDTM variables and domains to enable the display from an activity selection to the corresponding target domain and structure.

Additional Features

To enhance user support, a new “Need Help?” link has been introduced, which can be customized via a configuration file to direct users to any specific internet or intranet page. By default, this link points to the OpenStudyBuilder project homepage (https://openstudybuilder.com/), providing easy access to additional resources and documentation.

The previously available “Process Overview” screen, which displayed the step-by-step process for study selection, structure updates, and purpose definition and more, has been removed. Since the menu structure already guides users through these steps, this screen was redundant and has now been deprecated to improve overall navigation.

The Administration Page has been enhanced, now allowing administrators to toggle different features on and off. One of the first available options is the ability to disable the "Analysis Study Metadata (New)" view, which is highly specific to sponsor standards and may not be relevant for all companies.

A new “Study Structures” page has been added under the Library section, categorized within the “Overview Pages” group. This feature provides an overview of studies with similar designs in terms of arms, epochs, and elements, helping Standards Developers analyse existing trial structures. The page aims to improve consistency in trial design, allowing users to identify and replicate common study structures, spot patterns and trends across trials and detect deviations from standard study designs. Studies with similar structures are automatically grouped and displayed in a single row, with columns indicating key study characteristics such as number of arms, epochs, elements, and cohort inclusion (Y/N).

Fixes and Enhancements

In addition to the new features, numerous enhancements and fixes have been implemented to further improve the OpenStudyBuilder experience. A full list of updates can be found in the changelog, but here are some of the most notable improvements:

• Expanded Consumer API – Now includes endpoints for retrieving studies, study visits, study activities, the detailed SoA, and the operational SoA.
• NeoDash Dashboard Styling – The dashboards have been updated from Neo4j’s default style to a more consistent OpenStudyBuilder design.
• Improved API Code – Refinements enhance readability and maintainability.
• New Filtering Options – The Clinical Programs view and Project view now include filter capabilities, allowing users to find relevant information more efficiently.
• End-User Information – User data storage has been refactored to support additional details, and is now displaying full usernames instead of initials.
• Protocol SoA Locking Improvements – A locked study’s Protocol SoA design is now protected against unintended changes over time.
• Consistent Visit Window Time Units – It is not enforced that time units are consistent within a study (e.g., avoiding a mix of weeks and days), improving protocol standardization.
• Import Script Updates – Enhancements to import scripts and data lay the groundwork for the upcoming Activity Instance Wizard Stepper, streamlining future workflow improvements.

Upcoming OpenStudyBuilder 0.14.1. Updated

A minor update (0.14.1) is already on the way and is expected to be released within the next two weeks. This update addresses a migration script issue. With that fix, the migration scripts can be used upgrade the database content.

Additionally, major API performance improvements have been implemented for epochs, visits, and activities when working with the Schedule of Activities (SoA). Since performance is a key priority, we are rolling out these enhancements as soon as possible to ensure a faster and more efficient user experience.

Short-Term-Roadmap

In parallel with ongoing development, continuous planning efforts are in place to define and prioritize upcoming features and improvements.

In Q1 2025, the StudyBuilder Team at Novo Nordisk will concentrate on four key areas:

• Enhancing Usability for Key Users – Expanding the user interface to allow creation and editing of groups, subgroups, activities, activity instances, and related items directly within the user interface. Additional refinements to the Schedule of Activities (SoA) editing process are also planned to further improve efficiency and ease of use.
• Supporting Phase 1 Studies – Addressing the unique requirements of early-phase trials, including multiple SoAs and cohort support. This effort will include additional functionality, testing, and fine-tuning to ensure seamless handling of these study designs.
• Advancing Data Collection & Specification – Strengthening the linking between activity instances, CRF items, and data exchange models to enhance automation. Enrich metadata to enable automation through linking.
• Improving Inbound & Outbound Data Exchange – Aligning processes for connecting the Veeva CRF library with OpenStudyBuilder to enable smoother synchronization and automation, ensuring seamless interoperability between systems.

As OpenStudyBuilder adoption grows, Novo Nordisk is actively exploring a sustainable contribution model to enable broader participation in its development and maintenance. Given the complexity and scale of the project, code contributions have not yet been enabled, but with increasing interest from companies looking to implement OpenStudyBuilder, discussions are underway to define the future approach for maintaining and evolving the solution.

In the scope of OpenStudyBuilder, additional functionality could be implemented in three different ways. The “Core Contributions” are changes to the core source code of OpenStudyBuilder, currently owned, maintained, and released as open-source by Novo Nordisk. Discussions are ongoing about how the core can enable contributions and potentially include additional maintainers and owners in the future.

Then there is the option to create “OSB Extensions.” These extensions look and feel as if they were core functionalities integrated into the User Interface but are actually standalone features that could be developed, maintained, and delivered by anyone using any license. The idea is to have plug-and-play functionality that can be additionally installed depending on the need, similar to existing Word Plugins that can be purchased and used.

Finally, OpenStudyBuilder can integrate with various other applications, such as EDC systems, authoring tools, or any other relevant software. These integrations could also be developed, maintained, and delivered by anyone using any license. We already see integrations for Oracle and Marvin EDC systems, as well as the Marvin ePRO tool, and we anticipate many more in the coming year.

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. Please feel also free to join the OpenStudyBuilder Hub (OSB-Hub) - a collaboration team under the umbrella of the CDISC Open Source Alliance (COSA).

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.