OpenStudyBuilder #21 – Version 0.10

Release 0.10

We are thrilled to announce the latest release of OpenStudyBuilder! Version 0.10 is now available, packed with fantastic new features, enhancements, and fixes! As our platform continues to grow, we are excited to introduce more dashboards with highly relevant content.

You can now access these reports directly from the application. Simply click the "Reports" button in the top navigation bar. This will open a new tab with a landing page where all existing NeoDash reports and dashboards are available. These reports provide in-depth insights into the standards and study information stored in the StudyBuilder database.

As outlined in our roadmap, we are planning to support two different APIs. The first is a general native API that offers full functionality but is subject to frequent changes. The second is a new consumer API designed to support connections to external systems with greater stability. The initial version of this consumer API is live with this release, and more endpoints will be added soon! This new API ensures that resource-intensive integrations do not impact the performance of the core application using the native API.

Our advanced graph model supports a comprehensive version history, allowing you to track changes with precision. Explore our new NeoDash Report to effortlessly search and list controlled terminology code lists and terms, along with their historical evolution over time. This powerful feature ensures the visualization of the modifications of this data.

Supporting standards is one of the cornerstones of OpenStudyBuilder. The standard study structure export format from CDISC and TransCelerate is USDM. In our last release, we introduced an API endpoint that allows studies to be exported in USDM format. With this new release, we have integrated this standard directly into our user interface. You can now generate, view, and download a USDM representation of a study via the menu: Studies -> View Specifications -> USDM. Please note that the content currently includes a mix of USDM versions 2.7 and 3.0, and some fields are populated with placeholder text, which may not be ideal. We are continuously working on enhancing the export functionality and aligning with the latest USDM versions.

Due to the diverse study designs, additional features for visit specifications have been implemented. One such feature is the ability to specify a visit as 'Visit 0'. This visit is occasionally utilized in early-phase studies and is not expected to include any assessments. 'Informed Consent' is typically collected at a later visit, usually Visit 1. Visit 0 serves as an informational visit, for example, to instruct subjects to attend Visit 1 fasting.

Another new feature is 'repeating visits', which are commonly used in non-interventional studies. This feature is useful when participants need to return for the same visit multiple times based on their individual needs. For instance, one participant may come to Visit 3 five times, while another may have 10 visits as Visit 3. If there are specific requirements regarding the frequency of these repetitions (daily, weekly, monthly), they can be defined via the Repeating Frequency item. Note that Repeating Visits should be used when the number of repeats is not known in advance. If a fixed number of similar visits is planned, these should be created as single scheduled visits and grouped in a consecutive visit group.

For more detailed information about visit definitions, please refer to the software documentation, for the sandbox it is located here.

When adding a study visit, the list of "Existing Visits Names and Timing" can now display visit timing as either Week or Day, based on the "Time Unit" selected by the user in the Add Study Visit form. Additionally, a sticky bar has been added to all History pages, ensuring that actions for downloading or closing the window are always easily accessible without the need for scrolling.

Study visits can now be marked as Schedule of Assessment (SoA) milestones, allowing the related visit type to be displayed in the protocol SoA table header. On the protocol SoA page, you have the flexibility to choose whether to display the SoA milestones, the study epochs, or both. Furthermore, the SoA milestones can also be visualized on the Study Design figure, providing a comprehensive overview of the study's timeline and assessments. Please check the software documentation for additional information. In the sandbox this is located here.

The?API?has been updated with preparations to support compounds. As we undergo a major refactoring for compounds, you will notice updates in the API, although the functionality is not yet enabled for use. Additionally, the API now supports study selections related to sponsors and CDISC CT for the specific CT package selected for the study.

The?User Interface?has received style updates, particularly in table visualizations. Previously, data updates were sometimes missing when switching pages or tabs; this issue has been resolved, and data is now refreshed from the back-end when switching.?Clinical Programs?and?Projects?can now be created, edited, and deleted directly through the user interface.

The?Activities?section has undergone various updates. Performance improvements have been made for searching and managing activities in the Library. Additionally, when adding activities from other studies, you can now search for a study using its acronym instead of the study ID. A redesign of the Schedule of Activities and the footnotes section has also been initiated, combining several of the SoA tabs into one for a more streamlined experience.

In addition to introducing new features, enhancements, and refactoring, we have resolved numerous bugs. These fixes include improvements to searches and filters, corrections for missing item displays, elimination of duplicates, and more. For a comprehensive list of all changes and fixes, please refer to the detailed release change log available here.

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.