- The use of SPDEVID and PTREFID in this example on records where PTSPEC=AEROSOL indicates that a smoking machine (shown in SPDEVID) was used to perform the smoking vaping regimen (shown in PTREFID) to produce the aerosol from the e-liquid product on records where PTSPEC=AEROSOL. Details of the smoking machine and smoking vaping regimen are not shown in this example. For examples illustrating how to represent these concepts in SDTM, see Section 3.1.3.2, HPHCs, Other Constituents, and Smoking / Vaping Regimens.
- PTXFN (External File Path) is used to document the location or file name within the submission that contains the lab methodology protocol used to assay the associated constituent when such methodology is too complex for the single PTMETHOD variable.
- STOCONID is used to identify the storage conditions of the e-liquid product for the testing performed. Details of these conditions are represented in the ES dataset example that follows the two PT dataset examples.
- In this example, the applicant chose to sub-categorize some consituents and parameters using the permissible variable PTSCAT (Sub-Category of Test).
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