DATA STANDARDS – REQUIREMENT OR OPPORTUNITY

Data standards for clinical trials are a regulatory requirement which becomes an opportunity when enabled by technology. There are challenges though:

The first challenge centers around the management of data standards. The key insight here is to consistently treat data standards as metadata describing the actual data. How apt would it be to use an approved metadata standard to manage clinical trial data standards? The ISO 11179 standard for Metadata Registries (MDR) specifies a systematic framework that does just that. Apart from defining a metadata domain model, it contains provisions for the versioning and governance of metadata elements, which are key requirements to implement robust company processes around data standards management. The core of the Nurocor Clinical Platform (NCP) implements an ISO 11179 compliant Metadata Registry (MDR), and further extends it with library, workflow, audit, user management, and system integration capabilities to ensure a scalable enterprise application platform.

When clinical data standards are represented in a metadata registry, the standards themselves are digital and become actionable. This is a significant opportunity that goes well beyond the passive management of standards. The key insight here is to apply data standards early in the process, as soon as the clinical development plan and the study protocols are developed. The challenge is to link data standards, first upstream to study protocols in the study planning phase, and second, downstream to operational metadata in the study execution phase. A closer look shows that this information is highly interconnected while exposing many relationships across the clinical trial life cycle. This leads naturally to an information model that is better served by a graph model rather than tabular or hierarchical representations.

The Nurocor Clinical Platform (NCP) supports graph technology in several different ways. NCP can manage and publish information as linked data graphs based on the W3C Resource Description Framework (RDF). This is the technology used by Nurocor to implement the CDISC Library platform. It gives CDISC members access to a CDISC standards API with integrated search and browse capabilities. Furthermore, NCP as a platform follows a microservice architecture that can store data in graph databases and expose API endpoints using either a REST or a GraphQL interface. The result is a robust enterprise platform that can connect and federate all the standards metadata and study information across the clinical trial life cycle from protocol development to regulatory submission.