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Term of the Day
Informed consent is the process in which a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention. The patient must be competent to make a voluntary decision about whether to undergo the procedure or intervention.
Study data tabulation model (SDTM)
SDTM (Study Data Tabulation Model) datasets are a standardized format for organizing and submitting clinical trial data to regulatory agencies such as the FDA (Food and Drug Administration) and EMA (European Medicines Agency).The SDTM is a model that defines a set of standard domains, or categories, that clinical trial data can be classified into, such as Demographics, Adverse Events, Medical History, Laboratory Results, and others. Each domain includes a set of predefined variables, or data fields, that are used to describe and record the data for that domain.
SDTM datasets are created by mapping the data collected in a clinical trial to the standard domains and variables defined in the SDTM. This process involves converting raw data from various sources, such as EDC systems, laboratory databases, or other data sources, into a standard format that can be easily submitted to regulatory agencies.SDTM datasets are typically submitted as part of a regulatory submission package, and are used by regulators to review and analyze clinical trial data. By standardizing the format of clinical trial data, SDTM datasets make it easier for regulators to review and compare data across different trials and sponsors, ultimately helping to ensure the safety and efficacy of new treatments and therapies for patients.