CDISC Foundational Standards are the basis of a complete suite of data standards, enhancing the quality, efficiency and cost effectiveness of clinical research processes from beginning to end. Foundational Standards focus on the core principles for defining data standards and include models, domains and specifications for data representation.
Standard for Exchange of Nonclinical Data (SEND)* is an implementation of the SDTM standard for nonclinical studies. SEND specifies a way to collect and present nonclinical data in a consistent format.
Clinical Data Acquisition Standards Harmonization (CDASH) establishes a standard way to collect data in a similar way across studies and sponsors so that data collection formats and structures provide clear traceability of submission data into the Study Data Tabulation Model (SDTM), delivering more transparency to regulators and others who conduct data review.
Study Data Tabulation Model (SDTM)** provides a standard for organizing and formatting data to streamline processes in collection, management, analysis and reporting.
Study Data Tabulation Model Implementation Guide (SDTMIG)** is intended to guide the organization, structure, and format of standard clinical trial tabulation datasets.
Analysis Data Model (ADaM)** defines dataset and metadata standards that support:
- Efficient generation, replication, and review of clinical trial statistical analyses
- Traceability between analysis results, analysis data, and data represented in SDTM
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.*Required by the FDA (U.S.) for new drug applications
*Required by the FDA (U.S.) for new drug applications
**Required by the FDA and PMDA (Japan) for new drug applications.