SDTM Example.Product HPHC Testing

The following example illustrates how to represent results from HPHC testing of a tobacco product under study using the Product Testing (PT) domain. This testing is conduct on samples of the product of interest, and if applicable samples of comparison products. Each product tested would have it's own unique sponsor-defined value for SPTOBID to identify the product. 

This example only shows test results for each constituent for one sample of one product that was tested. The sampling plan and testing plan including the number of samples of the products tested are determined by the sposnor. In reality, sponsors would have multiple product samples tested and those would be distinguished in the dataset. These sample identification information may be represented in PTREFID, and/ or PTSPID. In this example, SPTOBID indicated the product identification, and each sample of that product was numbered as Sample 1 thru Sample n. Many sponsor may use more specific codes to identify the source of product sample.          

The Trial Lookup table can be used to provide additional details on any test conditions or methods used to perform the testing.