The release of CDISC Open Rules has opened new possibilities for clinical research organizations (CROs) and pharmaceutical and biotech companies looking to ensure their clinical datasets are compliant and submission-ready. As a CRO with deep expertise in CDISC Open Rules, we have been closely involved in developing these machine-executable data conformance rules, and we can help organizations adopt this new open-source project to fit their specific needs.
As a guest speaker in a recent CDISC webinar, Roman Radelicki, Head of Data Technology, SGS, shared invaluable insights on how to build and implement custom rules using CDISC Open Rules. Here's a summary of the key takeaways from his presentation.
Watch the full webinar here
While CDISC provides a comprehensive set of data conformance rules, there are many scenarios where custom rules are necessary. As Roman explained, custom rules are particularly useful for validating internal data, managing vendor-specific datasets, or working with non-CDISC data formats. For example, Roman demonstrated how to create a rule to check if a test result was completed when a reference range indicator was populated – something not currently covered by the standard CDISC rules. This highlights how customization allows organizations to enforce specific checks that are crucial for data quality but may not be addressed by CDISC’s data conformance rules.
Two tools are central to getting started when creating custom rules: the CDISC Open Rules Engine and the Rule Editor.
In his presentation, Roman shared a couple of concrete use cases for creating custom rules that go beyond the standard CDISC governance set, illustrating CDISC Open Rules’ flexibility.
Authoring CDISC Open Rules often demands technical know-how, time and precision – resources not every clinical team has in abundance. That is why we have developed the CDISC Open Rules AI assistant: a conversational tool that simplifies rule creation, even for non-programmers. It helps you draft, improve and test rules by simply describing what you need in everyday language.
Want to experience it yourself? Get free access – no installation needed – by filling out your contact details. Try the assistant here.
While CDISC Open Rules offers great flexibility, the process of creating and implementing custom rules can be complex. Roman emphasized the importance of governance and organization when developing and using custom rules, especially when scaling across multiple teams. Without proper setup, it can become challenging to manage different sets of rules and ensure consistency in validation. Seeking expert guidance will help to ensure a smoother implementation and effective scaling.
Learn more about SGS’s CDISC Open Rules consultancy services
Building their own CDISC Open Rules provides organizations with the flexibility to adapt data validation processes to their specific needs. Whether it is creating rules for internal data cleaning or integrating non-CDISC datasets, the CDISC Open Rules Engine and Rule Editor are powerful tools for customization. However, to ensure the successful implementation and scaling of these tools, it is important to have a clear governance strategy and technical support.
SGS is the world’s leading Testing, Inspection and Certification company. We operate a network of over 2,700 laboratories and business facilities across 119 countries, supported by a team of 99,250 dedicated professionals. With over 145 years of service excellence, we combine the precision and accuracy that define Swiss companies to help organizations achieve the highest standards of quality, safety and compliance.
Our brand promise – when you need to be sure – underscores our commitment to trust, integrity and sustainability, enabling businesses to thrive with confidence. We proudly deliver our expert services through the SGS name and trusted specialized brands, including Brightsight, Bluesign, Maine Pointe and Nutrasource.
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