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The first pt.xpt dataset shows 7 constituents / parameters, each as a single replicate (PTREPNUM=1), at one time point (PTTPT=Week 0 / PTTPTNUM=1) and from one set of storage conditions (STOCONID= Condition 1) in order to illustrate the variables and terminology required to construct an SDTM-conformant PT dataset for a stability study of a smokeless product. Some constituent names (Values of PTTESTCD/PTTEST) appear twice because they are tested separately in both tobacco "as-is" and dried tobacco (as indicated by PTSPEC and PTSPCCND). Note that the constituent / parameter names shown do not represent an exhaustive list of the controlled terminology that will be developed to support representation of stability studies in SDTM.

Note
  • 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. 
  • 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 / parameter when such methodology is too complex for the single PTMETHOD variable.

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The second pt.xpt dataset shows testing for just one constituentparameter, product moisture,

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serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-157
performed in three replicates (note the values of PTREPNUM), at the first three time points of the study (as shown in PTTPT / PTTPTNUM), from two sets of storage conditions (STOCONID), in samples of both dried and as-is tobacco (PTSPEC, PTSPCCND) in order to illustrate how those variables are used to represent their associated concepts in a stability study. 

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