CDISC – SDTM and ADaM
CDISC stands for Clinical Data Interchange Standards Consortium, which is a global, non-profit organization that develops and promotes standards for the collection, management, analysis, and submission of clinical trial data.
The standards are used by clinical researchers, regulatory agencies, and pharmaceutical companies worldwide to ensure that clinical trial data is consistent, accurate and reliable.
CDASH, SDTM, ADaM, and CORE are all standards developed by Clinical Data Interchange Standards Consortium (CDISC) for the collection, management, analysis, and submission of clinical trial data.
CDASH (Clinical Data Acquisition Standards Harmonization) is a set of standards data collection fields and domains that provide a framework for the collection of clinical trial data in a consistent and standardized way. It includes templates for case report forms (CRFs) and defines the data elements that should be collected for each domains such as demographics, adverse events, medical history etc.
SDTM (Study Data Tabulation Model) is a standard format for organizing and structuring clinical trial data into tables, making it easier to analyze and compare across studies. It defines the variables and data structures that should be used for each domain, and provides guidelines for creating data sets that can be easily shared and analyzed by different parties.
ADaM (Analysis Data Model) is a standard format for organizing and structuring clinical trial data into datasets that are ready for statistical analysis. It defines the variables and data structures that should be used for each analysis dataset, including efficacy, safety and demographic data.
For someone who wants to break into the life science industry and excel in their role, it is important to have a basic understanding of these standards and how they are used in clinical trials. Familiarity with CDASH, SDTM, and ADaM can be particularly valuable for roles such as clinical data management, statistical analysis, and regulatory affairs.
