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Term of the Day

Natural History Study

A natural history study is a preplanned intended to track the course of the disease. Its purpose is to identify demographic, genetic, environmental, and other variables (e.g., treatment modalities, concomitant medications) that correlate with the disease’s development and outcomes. Natural history studies are likely to include patients receiving the current standard of care and/or emergent care, which may alter some manifestations of the disease.


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.