CDISC standards accelerate your clinical research submission process during DCTs and promote data-sharing and accessibility in clinical research. As DCT trials gain momentum, standardized data submission will continue to gain relevance. CDISC standards are increasingly encouraged and even required by a growing number of regulatory bodies. By understanding and adhering to them, you’ll also promote accessibility, interoperability, and reusability of data — ultimately accelerating breakthroughs.

This paper explores in detail the foundational standards, including:

  1. Protocol Representation Model (PRM)
  2. Clinical Data Acquisition Standards Harmonization (CDASH)
  3. Study Data Tabulation Model (SDTM)
  4. Analysis Data Model (ADaM)
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