What is a Clinical Study Report?
September 10, 2024
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Clinical Data Interchange Standards Consortium is a non-profit organization that provides a complete suite of standards for supporting clinical and non-clinical research processes. It is dedicated to improving complete medical research through standardizing the data. The organization states, ‘We develop and advance data standards of the highest quality to transform incompatible formats, inconsistent methodologies, and diverse perspectives into a powerful framework for generating clinical research data that is as accessible as it is illuminating.’1
CDISC promotes many worldwide standards aimed at improving the quality and interoperability of research and healthcare. During clinical trials or non-clinical research, US Food and Drug Administration, urge collecting, organizing, and analyzing the data as per the standards set by CDISC.
Clinical Data Interchange Standards Consortium supports various standards to promote the smooth process of the research (as shown in figure below). However, there are three key standards that CDISC supports, including the (SDTM), (ADaM), and (SEND).2
Of these, SDTM and ADaM are CDISC standards for clinical research, whereas SEND is used for nonclinical investigations. In addition, SEND is basically an implementation of the SDTM standards for non-clinical investigations. Other than this, CDISC also promotes Clinical Data Acquisition Standards Harmonization (CDASH). In this blog, we’ll briefly discuss these standards and their relevance and importance in clinical and non-clinical research.
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