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Training Description:
Creating high-quality data packages for analysis, reporting, and submission is crucial in drug development. To guide the industry with data quality checks, CDISC has developed the CDISC Conformance Rules as part of the Foundational Standards. Regulatory authorities have also defined their own business rules. The current biggest challenge is that these rules are descriptive and non-executable.
To automate conformance checks, CDISC has launched the CORE project (CDISC Open Rule Engine). This project aims to provide clear and executable Conformance Rules, along with an open-source execution engine available from the CDISC Library. This training offers a comprehensive overview of the CORE project, including its open-source components, hands-on practice, and guidance for adoption within your company. It’s time to prepare your processes and data packages for the future.
