Why Data Standards Matter

Data standardization is very important to help people with rare diseases live better and fuller lives. Because patient groups are small, there are significant challenges in the design, conduct, analysis, and interpretation of clinical studies. Data standards help address these challenges.

What NORD Is Doing With CDISC Data Standards

We are partnering with the Clinical Data Interchange Standards Consortium (CDISC) to develop global data standards for rare diseases. CDISC standards drive operational efficiencies within the organizations that use them, expedite the regulatory review process, and reduce time to market for treatments developed based on patient data.

To date, CDISC has developed Therapeutic Area User Guides for over 40 disease areas. Therapeutic Area User Guides provide examples and guidance on implementing CDISC standards so data can be structured effectively and easily analyzed.

The rare disease data standards will be released in a Therapeutic Area User Guide that will be available at no cost on the CDISC website for researchers to leverage in studies to maximize data’s full potential.