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The first PT dataset shows 7 constituents/parameters, each as a single replicate (PTREPNUM=1), at 1 time point (PTTPT=Week 0 / PTTPTNUM=1) and from 1 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 PTSPCCNDtheir results are reported two separate ways: once for the result as tested and once where the result is expressed as dry weight basis (the latter is indicated by PTTSTDTL = DRY WEIGHT BASIS). 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.

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Row 1:

Shows the PTTEST of product moistureMoisture Content, which reflects the percentage of moisture in the substance for the condition noted in STOCONID (i.e., Condition 1).  Product moisture Moisture Content is used in chemistry stability studies. For microbial stability studies, water activity Water Activity should be used, not product moisture Moisture Content (see row 3).

Rows 4, 6, 8:Show the NNK , and NNN , and TSN tests with the tobacco product "AS-IS" using the PTSPCCND to show that the tobacco is "FRESH"results from the tobacco product as tested.
Rows 5, 7, 9:Show the NNK , NNN, and TSN tests with the tobacco product as "DRY WEIGHT BASIS" and NNN test results as dry weight basis (DWB) using the PTSPCCND to show that the tobacco is "DRIED".. Note the use of PTTSTDTL = "DRY WEIGHT BASIS"
Rows 2-3, 8-119:

Show the other analytes used measured in testing (i.e., pH, water activity, NNK, NNN, TSNA) using the PTTEST and PTTESTCD variables.

Dataset2
RowSTUDYIDDOMAINSPTOBIDSTOCONIDPTSEQPTTESTCDPTTESTPTTSTDTLPTCATPTORRESPTORRESUPTLLODPTSTRESCPTSTRESNPTSTRESUPTXFNPTNAMPTSPECPTSPCCNDPTLLOQPTREPNUMPTDTCPTTPTPTTPTNUM
1TOB07PTSmokeless01Condition 11PRODMSTMOISTCTTProduct Moisture Content
STABILITY STUDYTESTING52.0%0.152.052.0%

TLT07_V1

TPT LABCOTOBACCO0.12102-01-2023Week 01
2TOB07PTSmokeless01Condition 12PHpH
STABILITY STUDYTESTING8.06

8.068.06
TL009_V1TPT LABCOTOBACCO
102-01-2023Week 01
3TOB07PTSmokeless01Condition 13H2OACTWater Activity
STABILITY STUDYTESTING0.86
0.010.860.86
TLPH01_V1TPT LABCOTOBACCO0.05102-01-2023Week 01
4TOB07PTSmokeless01Condition 14NNKNicotine-Derived Nitrosamine Ketone
STABILITY STUDYTESTING1.0225ug/g0.011.02251.0225ug/gTL026_V12.2TPT LABCOTOBACCOAS-IS0.05102-01-2023Week 01
5TOB07PTSmokeless01Condition 15NNKNicotine-Derived Nitrosamine KetoneDRY WEIGHT BASISSTABILITY STUDYTESTING0.4908ug/g0.010.49080.4908ug/gTL026_V12.2TPT LABCOTOBACCODRIED0.05102-01-2023Week 01
6TOB07PTSmokeless01Condition 16NNNN-Nitrosonornicotine
STABILITY STUDYTESTING4.4633ug/g0.014.46334.4633ug/gTL026_V12.2TPT LABCOTOBACCOAS-IS0.05102-01-2023Week 01
7TOB07PTSmokeless01Condition 17NNNN-NitrosonornicotineDRY WEIGHT BASISSTABILITY STUDYTESTING2.1424ug/g0.012.14242.1424ug/gTL026_V12.2TPT LABCOTOBACCODRIED0.05102-01-2023Week 01
108TOB07PTSmokeless01Condition 18AEBPLCTAEBCTAerobic Plate Colony Count
STABILITY STUDYTESTING154000CFU/g1154000154000CFU/gTLMB_V1.1TPT LABCOTOBACCO1102-01-2023Week 01
119TOB07PTSmokeless01Condition 19TYMCYSTMLDCTTotal Yeast and/or Mold Colony Count
STABILITY STUDYTESTING<10CFU/g1<10
CFU/gTLMB_V1.1TPT LABCOTOBACCO1102-01-2023Week 01
Info

The second PT dataset shows testing for just 1 parameter (product moistureMoisture Content), performed in 3 replicates (note the values of PTREPNUM), at the first 3 time points of the study (as shown in PTTPT/PTTPTNUM), from 2 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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Rows 1-9:

Show the results of testing product moisture Moisture Content in 3 replicates (PTREPNUM) at 3 timepoints (weeks 0, 8, and 24) under the storage "Condition 1" (STOCONID). 

Rows 10-18:Show the results of testing product moisture Moisture Content in 3 replicates (PTREPNUM) at 3 timepoints (weeks 0, 8, and 24) under the storage "Condition 2" (STOCONID). 
Dataset2
RowSTUDYIDDOMAINSPTOBIDSTOCONIDPTSEQPTTESTCDPTTESTPTORRESPTORRESUPTLLODPTSTRESCPTSTRESNPTSTRESUPTXFNPTNAMPTSPECPTSPCCNDPTLLOQPTREPNUMPTDTCPTTPTPTTPTNUM
1TOB07PTSmokeless01Condition 1111PRODMSTMOISTCTTProduct Moisture Content51.93%0.151.9351.93%TLT07_V1TPT LABCOTOBACCOAS-IS0.12102-01-2023Week 01
2TOB07PTSmokeless01Condition 1112PRODMSTMOISTCTTProduct Moisture Content51.96%0.151.9651.96%TLT07_V1TPT LABCOTOBACCOAS-IS0.12202-01-2023Week 01
3TOB07PTSmokeless01Condition 1113PRODMSTMOISTCTTProduct Moisture Content51.98%0.151.9851.98%TLT07_V1TPT LABCOTOBACCOAS-IS0.12302-01-2023Week 01
4TOB07PTSmokeless01Condition 1114PRODMSTMOISTCTTProduct Moisture Content51.75%0.151.7551.75%TLT07_V1TPT LABCOTOBACCOAS-IS0.12103-29-2023Week 82
5TOB07PTSmokeless01Condition 1115PRODMSTMOISTCTTProduct Moisture Content51.75%0.151.7551.75%TLT07_V1TPT LABCOTOBACCOAS-IS0.12203-29-2023Week 82
6TOB07PTSmokeless01Condition 1116PRODMSTMOISTCTTProduct Moisture Content51.67%0.151.6751.67%TLT07_V1TPT LABCOTOBACCOAS-IS0.12303-29-2023Week 82
7TOB07PTSmokeless01Condition 1117PRODMSTMOISTCTTProduct Moisture Content52.05%0.152.0552.05%TLT07_V1TPT LABCOTOBACCOAS-IS0.12107-19-2023Week 243
8TOB07PTSmokeless01Condition 1118PRODMSTMOISTCTTProduct Moisture Content52.68%0.152.6852.68%TLT07_V1TPT LABCOTOBACCOAS-IS0.12207-19-2023Week 243
9TOB07PTSmokeless01Condition 1119PRODMSTMOISTCTTProduct Moisture Content52.21%0.152.2152.21%TLT07_V1TPT LABCOTOBACCOAS-IS0.12307-19-2023Week 243
10TOB07PTSmokeless01Condition 2120PRODMSTMOISTCTTProduct Moisture Content51.93%0.151.9351.93%TLT07_V1TPT LABCOTOBACCOAS-IS0.12102-01-2023Week 01
11TOB07PTSmokeless01Condition 2121PRODMSTMOISTCTTProduct Moisture Content51.96%0.151.9651.96%TLT07_V1TPT LABCOTOBACCOAS-IS0.12202-01-2023Week 01
12TOB07PTSmokeless01Condition 2122PRODMSTMOISTCTTProduct Moisture Content51.98%0.151.9851.98%TLT07_V1TPT LABCOTOBACCOAS-IS0.12302-01-2023Week 01
13TOB07PTSmokeless01Condition 2123PRODMSTMOISTCTTProduct Moisture Content51.80%0.151.8051.80%TLT07_V1TPT LABCOTOBACCOAS-IS0.12103-29-2023Week 82
14TOB07PTSmokeless01Condition 2124PRODMSTMOISTCTTProduct Moisture Content51.77%0.151.7751.77%TLT07_V1TPT LABCOTOBACCOAS-IS0.12203-29-2023Week 82
15TOB07PTSmokeless01Condition 2125PRODMSTMOISTCTTProduct Moisture Content51.84%0.151.8451.84%TLT07_V1TPT LABCOTOBACCOAS-IS0.12303-29-2023Week 82
16TOB07PTSmokeless01Condition 2126PRODMSTMOISTCTTProduct Moisture Content52.18%0.152.1852.18%TLT07_V1TPT LABCOTOBACCOAS-IS0.12107-19-2023Week 243
17TOB07PTSmokeless01Condition 2127PRODMSTMOISTCTTProduct Moisture Content52.21%0.152.2152.21%TLT07_V1TPT LABCOTOBACCOAS-IS0.12207-19-2023Week 243
18TOB07PTSmokeless01Condition 2128PRODMSTMOISTCTTProduct Moisture Content51.87%0.151.8751.87%TLT07_V1TPT LABCOTOBACCOAS-IS0.12307-19-2023Week 243

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