Food and fluid intake data represent nutrients (ingredients) in a consumed meal (regimen) composed of food and other sources of nutrition, including beverages. The nutrient amounts are derived from collected data on the quantities of products within a meal, and data on the nutrients within products.
Currently, there is no consensus regarding the best way to represent food and fluid intake data in the SDTM. Various strategies have been used across published standards to represent this type of "parent" and "child" data. The Combination Therapy sub-team is focused on finding a unified approach that can be applied across all disease areas and will take account of this nutrition concept.