What are CDISC Foundational Standards?
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.
What are Data Exchange Standards?
CDISC Data Exchange Standards facilitate the sharing of structured data across different information systems.
What are CDISC Therapeutic Areas?
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.
What is Controlled Terminology?
CDISC Controlled Terminology (CT) is the set of CDISC-developed or CDISC-adopted standard expressions (values) used with data items within CDISC-defined datasets. CDISC, in collaboration with the National Cancer Institute's Enterprise Vocabulary Services (EVS), supports the controlled terminology needs of CDISC Foundational and Therapeutic Area Standards.
What are Questionnaires, Ratings, and Scales (QRS)?
Each QRS instrument is a series of questions, tasks or assessments used in clinical research to provide a qualitative or quantitative assessment of a clinical concept or task-based observation. The QRS team develops Controlled Terminology and SDTM (tabulation) supplements; the ADQRS Team develops ADaM (analysis) supplements.
Which CDISC Standards are required for submissions by regulatory authorities?
FDA Required CDISC Standards:
Additionally, FDA-supported CDISC Therapeutic Area Standards are updated periodically in the FDA Study Data Technical Conformance Guide.
PMDA Required CDISC Standards:
What are the benefits of implementing CDISC Standards?
The benefits of implementing CDISC Standards include:
- Fostered efficiency
- Complete traceability
- Enhanced innovation
- Improved data quality
- Facilitated data sharing
- Reduced costs
- Increased predictability
- Streamlined processes