CDISC Foundational Standards are the basis of the complete suite of standards, supporting clinical and non-clinical research processes from end to end. Foundational Standards focus on the core principles for defining data standards and include models, domains and specifications for data representation.
Therapeutic Area (TA) Standards extend the Foundational Standards to represent data that pertains to specific disease areas. TA Standards include disease-specific metadata, examples and guidance on implementing CDISC standards.
CDISC Standards specify how to structure the data; they do not specify what data should be collected or how to conduct clinical trials, assessments or endpoints.
FDA and PMDA require the use of CDISC Standards for regulatory submissions.
Global, vendor-neutral, platform-independent, CDISC Standards are freely available on our web site.
Benefits of implementing CDISC standards include:
- Fostered efficiency
- Enhanced innovation
- Facilitated data sharing
- Increased predictability
- Complete traceability
- Improved data quality
- Reduced costs
- Streamlined processes