PHUSE EU Connect 2024 abstract
Implementing CDISC CORE in a cloud native,
regulated environment supporting
Rare Diseases submissions
by Emmy Pahmer & Sandeep Juneja (argenx)
The focus of our presentation is to share with the CDISC community our journey implementing the CDISC Open Rules Engine (CORE) within the SAS Life Science Analytics Framework (LSAF) environment at argenx. CORE is a free open-source tool for validating CDISC and regulatory conformance. LSAF is a closed system which provides a 21 CFR Part 11 compliant,
web-based, Statistical Computing Environment (SCE) and Structured Data Repository where study data can be securely stored with versioning and audit history capabilities. Argenx is a global immunology company, committed to improving the lives of people suffering from severe autoimmune diseases.We will highlight challenges encountered and insights gained during the implementation process. We also plan to perform an evaluation of CORE functionality, running the rules for rare disease studies. We will also share potential plans for the future in supporting the development of the CORE engine.
Implementing CDISC CORE in a cloud native,
regulated environment supporting
Rare Diseases submissions
by Berber Snoeijer (ClinLine) & Jules van der Zalm
Enabling an end-to-end data flow of real-world data from source to regulator involves a number of different data standards. As FHIR’s main use is the exchange of electronic health record information through JSON formatted files, it falls short in data selection and fit-for-purpose evaluation. On the other hand, direct transfer to CDISC SDTM would entail extensive mapping, which might not be necessary for the majority of patients. Moreover, SDTM format is not optimal for fit-for-purpose assessments and imputation. We propose aligning and standardizing the essential intermediary stage of data transformation. The OMOP standard serves this purpose very well as it includes a number of source traceability variables and standardized mapping of concepts. In this presentation, we will demonstrate how we add custom variables to the OMOP standard to allow for full end-to-end traceability and seamless mapping to SDTM.