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.
This four-hour training covers the following topics:
- CORE project overview: Understand the purpose and significance of the CORE project in the industry and learn about its benefits.
- Focusing on the CORE components: Explore the Rule Editor and Rule Engine in detail, gaining a comprehensive understanding of their functionalities.
- CORE Rule Creation:
- Learn step-by-step how to write and validate rules using the Rule Editor. Discover best practices for rule creation and validation to ensure accuracy and effectiveness.
- Hands-on exercises: Engage in practical exercises that allow attendees to individually write and validate rules based on the provided template, enhancing understanding and proficiency.
- CORE Data Validation:
- Dive into the process of using the Rule Engine to validate your data packages. Gain insights into the functionalities and features of the Rule Engine and learn how to effectively utilize it for data validation purposes.
- Hands-on exercises: Participate in exercises designed to deepen your understanding of how the rule engine works.
- Explore company implementation possibilities: Receive guidance on how to get started with your own adoption of the CORE project within your organization.
Learning Outcomes
At the end of this training, learners will be able to:
- Understand the CDISC Open Rules project and its impact and value in drug development
- Master CDISC Open Rules components: Rule Editor & Rules Engine functionalities
- Create and validate data conformance rules via the Rule Editor
- Employ Rules Engine for effective data validation
- Start CDISC Open Rules adoption based on synthesized information
Vendor Neutrality Disclaimer
- CDISC is vendor-inclusive and does not endorse any specific vendor or technology in the use of its standards.
