The Clinical Data Interchange Standards Consortium (CDISC) began in 1997 as a grassroots initiative, in response to the need to better structure and improve the quality and consistency of data in clinical research. Today, CDISC is a global nonprofit charitable organization 501(3)(C), headquartered in Austin, Texas, with the CDISC Europe Foundation located in Brussels, Belgium.
CDISC develops vendor-neutral, consensus-based, community-developed standards that enable the accessibility, interoperability, and reusability of data.
The following CDISC standards are required for submissions to the United States Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA):
CDISC standards are freely available on the CDISC website.
The consortium brings together a community of members across the clinical research lifecycle – from researchers to reviewers. CDISC collaborates with global partners, like Formedix, so they can continue to advance interoperable data standards, achieve greater clarity, and enable more powerful research.
In this case study, we will explore our 23-year partnership with CDISC. We will take a look at a number of collaborative projects that have driven the development and implementation of CDISC standards, to the benefit of all stakeholders in the clinical trial enterprise, including patients.
Formedix was among the first CDISC members 20 years ago. Today, we are a proud and active member of the CDISC Data Exchange Standards team.
In the early days, CDISC created the Operational Data Model (ODM)⁵ to outline how studies should be structured. At the same time, Formedix was defining technologies for rapid study build.
In 2003, Kevin Burges, now Head of Product Management at Formedix, joined the CDISC team as a reviewer for ODM specifications. Kevin brought “real world” experience from working with Formedix customers, and added direct value to the standards development process.
In 2004, Kevin received an outstanding achievement award from CDISC in appreciation of his dedication and hard work in developing the standards with the ODM team.
By the 2010s, CDISC was focusing on increasing adoption of the standards to support faster, easier, higher quality data submissions to global regulatory authorities.
As Formedix’s client base grew, our CEO and Founder, Mark Wheeldon became a key champion for the CDISC models. He understood why they were so crucial and how they could enable efficient, better-quality study build. He also saw how important it was to ensure semantic interoperability, and how the models could facilitate getting medicines to patients who need them faster.
In talking about the power of CDISC standards, Mark says:
CDISC brought together traditionally siloed functions (i.e., data managers, biostatisticians, clinicians, and terminologists) during the standards development process, which resulted in quality, implementable standards. CDISC encouraged stakeholders to think in advance about the studies they were designing, the outputs, and the best ways to achieve success.
CDISC standards provide a common structure and terminology for data collection, aggregation, analysis, and transfer. There are many benefits of adopting CDISC standards, including supporting the following:
Along with the promise of creating implementation standards, CDISC faced the challenge of encouraging a risk-adverse pharmaceutical industry to shift away from traditional methods of data collection.
In the early days of CDISC standards, electronic data capture was still a relatively new concept; in Formedix’s experience, around 70% of studies we were involved with still used paper case report forms (CRFs).
CDISC knew that the key to wider standards adoption was to minimize barriers and make the standards easier to implement.
In 2011, they created a set of standardized CRFs aligned to SDTM, called CDASH. In 2021, to simplify the adoption of CDASH, CDISC decided to create an eCRF Portal, to make the CDASH content more easily accessible in human readable and machine readable forms. This would encourage use, drive better data quality, and make SDTM conversions more straightforward.
At the time, CDISC was using a metadata repository to create and store forms. However, they realized a platform was needed to visualize forms in an electronic data capture (EDC) system before patient data was collected.
By this point, Formedix had more than two decades of experience working with CDISC standards. We had recently launched the ryze clinical metadata repository⁶ – a centralized, cloud-based platform for creating standards and forms that generates CRF visualizations.
We were already using this technology to define, standardize and visualize eCRF metadata, so it was clear that the same mechanism could be used to create an ODM-based implementation of a set of standardized CDASH forms.
CDISC used ryze to create a suite of ready-to-use, CDASH-compliant, annotated eCRFs. CDISC could easily create ODM implementations of the CDASH forms, and existing visualizations in ryze were used to provide HTML and PDF previews of what the CRFs look like and how they map to SDTM.
ryze demonstrated how the new collection metadata could be leveraged to generate visualizations of what forms will look like in an EDC system, including SDTM annotations.
These are freely available to download from the CDISC eCRF portal today. They’re also available directly within the ryze clinical metadata repository. The templates can also be exported as SDTM-annotated CRFs in PDF format, as well as various HTML and XML formats.
During our long collaborative history with CDISC, we’ve brought a practical approach to help make CDISC standards workable in real-world study design.
In 2022, we launched ryze labs, an R&D function dedicated to exploring how we can further drive efficiencies in the clinical trial process. The focus is on speeding development, iterating ideas with our customers, and uncovering new ideas and innovations to benefit all stakeholders. We actively work with CDISC and customers to create use cases and prototypes to help drive future efficiencies in the drug development process.
The industry is shifting to become more focused on academic research. Formedix is actively collaborating with CDISC on outreach to academic organizations.
We recently presented a joint webinar to help academic institutions understand the role of standardization in making data clearer and more impactful. Watch the webinar >> The need for standardization and CDISC – Insights from The University of Alabama, The University of Utah & CDISC.
The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability. Their overriding goal is to improve medical research and related areas of healthcare.
In 2023, CDISC launched the innovative CDISC Open Rules Engine (CORE). It was designed to deliver a governed set of unambiguous and executable conformance rules for each foundational standard.⁹
In support of this effort, Formedix CORE was launched as a free-to-use desktop application incorporating the CORE engine. This application provides in-stream quality checks as conversions are performed. The aim is to keep the data as close to submission ready as possible, and to ensure quality in all data exchange scenarios.
Since creating the first clinical trial design tool based on CDISC standards in 2004, Formedix continues to lead the way in CDISC standards implementation and innovation. We look forward to a continued close partnership with CDISC, with our ultimate aim of improving the speed, quality and ease of clinical study build.
The ryze metadata repository and clinical trial automation platform will help you design, build, and submit your trials much faster than before.
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