SDTM Example.Stability Study for E-Liquid Products

The example shown below is not an all inclusive comprehensive example.  It is meant to be illustrative of the concepts.

Shelf life study has a protocol and provides the results of shelf life studies of Vapes products over time with different conditions and analytes.  Generally there are many conditions with at least two with varying temperature, humidity, etc. The initial table shows the a number of the analytes and test conditions used in Shelf Life studies for Vapes products for one testing condition at one timepoint and one replicate.

Tobacco Product Testing (TT) is a Findings domain similar to the Laboratory Test Results domain.

PTCAS variable (in place of the LBLOINC variable) provides the accurate chemical name, structure for organic and inorganic substances.

A Shelf Life study dataset would shows analytes done in different test conditions with replicates over time points.  In the interest of brevity for this example, only portions of the content using the TEST of Nicotine is shown in a sample of timepoints in two conditions with replicates. The weeks reflective of Week 1,  Week 2, Week 3, etc. which would align with the PTTPTNUM of 2,3, etc. are not shown for visual viewing purposes. This is an example, this provides possible tests that might be used to demonstrate how to use the datasets and variables to show what was done for the shelf-life stability study. It shows what timepoint and what type of data follows. It is important to show different test conditions for each analyte. For aerosol a machine similutaion is use so mg/puff is valid.

The Test Conditions (TL) dataset allows for listing the attributes of the testing regimens used in tobacco product testing when the details are too long and variable for representing as a single value in the PTTSTCND variable in a PT dataset. 

The example below shows the attributes of the testing regimen identified as PTTSTCND="E-Liquid Standard Aerosol Condition" (see e-liquid stability study pt.xpt example). Note that the combination of TCVAR1="PTTSTCND" and TCVRVAL1="E-Liquid Standard (Long Term) Condition" identifies the specific testing regimen shown in PTTSTCND as the focus of the testing regimen parameters listed in TLPARMCD/TLPAM. TLVAL and TVALU show the specific values and units (respectively, where applicable) for the given parameter.one testing regimen shown in the PT stability study above. 
(We've added TLVALU which was not originally part of the TL draft domain. May propose elevating this structure to a "Trial Lookup" observational class, within which some domains would allow for TLVALU) 

TO BE ARCHIVED; NOT FOR REVIEW. The Test Conditions (TC) dataset allows for listing the attributes of the testing regimens used in tobacco product testing when the details are too long and variable for representing as a single value in the PTTSTCND variable. Values of PTTSTCND used in any PT dataset can be described in the TC dataset.

The example below shows the attributes of one testing regimen shown in the PT stability study above.