Page History

Tobacco product stability HPHC testing study results are represented in PT. These are just the data that show the testing results under specific storage conditions and smoking regimens. The details of the regimen and storage conditions are shown in separate datasets that follow this example.

• The smoking regimen is carried out by the smoking machine/device shown in SPDEVID (sponsor-defined device identifier).
• The storage condition is represented in STOCONID (Storage condition identifier- this variable as created after consultation with our internal standards modeling team).
• The smoking regimen is represented in PTREFID (we made up a value; we can update with something realistic)
• We got buy-in on using a new variable, "PTMATRIX" (for the sample matrix), since the existing SDTM "specimen type" variable was not appropriate.
• PTCAT represents the type of testing such as HPHC Testing or Design Parameter Testing
• PTSCAT represents HPHC vs other constituents

https://www.ecigstats.org/docs/research/CoA_1R6F.pdf - This is a sample Smoking Regime that was used as the basis of the example.

This testing is conducted 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. 

https://open.canada.ca/data/https://open.canada.ca/data/en/dataset/71394df3-aee8-4117-92cb-a035360972a2/resource/7e6b0457-051e-4620-befc-8e4f50b75345 

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 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 sponsor. 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 sponsor. In reality, sponsors would have multiple product samples tested and those would be distinguished in the dataset.

the old example - from the original HPHC (as opposed to the one with the device and smoking regimen)

...