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Foundational Standards

 

CDISC Foundational Standards are a basis of a complete suite of data standards, enhancing the quality, efficiency and cost effectiveness of clinical research processes supporting from beginning to end. Foundational Standards focus on the core principles for defining data standards and include models, domains and specifications for data representation.

Protocol Representation Model (PRM) provides a standard for planning and designing a research protocol with focus on study characteristics such as study design, eligibility criteria, and requirements from the ClinicalTrials.gov, World Health Organization (WHO) registries, and EudraCT registries. PRM assists in automating CRF creation and EHR configuration to support clinical research and data sharing.

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

Questionnnaires, 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.