SDTM Example. Product Description - Ingredients and Additives

This example illustrates how the list of ingredients of a tobacco product would be represented. 

The unique tobacco product substances interest would be assigned a STRFID identifier in the (IL)  Ingredient List domain.  The SPTOBID identifier is included in this IL domain to identify the tobacco product to which these ingredient data pertain. INCAT is used to differentiate the different categories of ingredient. INSCAT may be used to further differentiates sub categorize these ingredients. INCAT/INSCAT categories would be detemined by the sponosr and typically depend on the type of tobacco product being described. STRFID indicates the Reference ID assigned to the substance/ingredient by the sponosr. Each ingredient/substance record must be unique. Hence, the mu  In this example the FDA UNII number was used. This was used since not all ingredients have a CAS Number, but usually have have UNII numbers. The information on what dictionary/code list was associated with STRID is provided in the define.xml that is submitted with the data. For example,. The same Iingredient from different manufacturers would be listed on separate lines. 

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This example represents the target and max and minimum quanity of each unique ingredients in each compoment of  a tobacco product.  STRFID must be represented using the identical value defined by the sponosr in the Ingredient (IL) domain.  IQUNIT is the unot assoicated with the target, min, and max.