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The first pt.xpt PT dataset shows 7 constituents/parameters, each as a single replicate (PTREPNUM=1), at one 1 time point (PTTPT=Week 0 / PTTPTNUM=1) and from one 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 / PTSPECCNDtheir 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.

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
  • 2 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.
Dataset wrap
Namept
Rowcaps
Row 1:

Shows the PTTEST of

Product

Moisture Content, which reflects the percentage of moisture in the substance for the condition noted in STOCONID

which is

(i.e., Condition 1). 

Product

Moisture

is sometimes referred to as "Oven Volatiles"

Content is used in chemistry stability studies. For microbial stability studies, Water Activity should be used, not Moisture Content (see row 3).

Rows 4, 6, 8:Show the NNK , and NNN , and TSN tests with the results from the tobacco product "AS-IS" using the PTSPCCND to show that the tobacco is "FRESH"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

(pH, water activity, NNK, NNN, TSNA, etc

.

) using the PTTEST and PTTESTCD variables.

Dataset2
PTSPCCND
RowSTUDYIDDOMAINSPTOBIDSTOCONIDPTSEQPTTESTCDPTTESTPTTSTDTLPTCATPTORRESPTORRESUPTLLODPTSTRESCPTSTRESNPTSTRESUPTXFNPTNAMPTSPECPTLLOQPTREPNUMPTDTCPTTPTPTTPTNUM
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 LABCOTOBACCO, FRESHAS-IS0.05102-01-20231Week 01
5TOB07PTSmokeless01Condition 15NNKNicotine-Derived Nitrosamine KetoneDRY WEIGHT BASISSTABILITY STUDYTESTING0.4908ug/g0.010.49080.4908ug/gTL026_V12.2TPT LABCOTOBACCO, DRIED0.05DRY WEIGHT102-01-2023Week 01
6TOB07PTSmokeless01Condition 16NNNN-Nitrosonornicotine
STABILITY STUDYTESTING4.4633ug/g0.014.46334.4633ug/gTL026_V12.2TPT LABCOTOBACCO, FRESHAS-IS0.05102-01-20231Week 01
7TOB07PTSmokeless01Condition 17NNNN-NitrosonornicotineDRY WEIGHT BASISSTABILITY STUDYTESTING2.1424ug/g0.012.14242.1424ug/gTL026_V12.2TPT LABCOTOBACCO, DRIED0.05DRY WEIGHT102-01-2023Week 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/g<101<10
CFU/gTLMB_V1.1TPT LABCOTOBACCO1102-01-2023Week 01
Info

The second pt.xpt PT dataset shows testing for just one constituent, nicotine1 parameter (Moisture Content), performed in three 3 replicates (note the values of PTREPNUM), at three the first 3 time points of the study (as shown in PTTPT/PTTPTNUM), from three 2 sets of storage conditions (STOCONID), in samples of e-liquid and aerosol )PTSPECboth 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. 

Note
  • As in the first pt.xpt dataset, the details of the smoking machine and smoking regimen are not shown in this example. For examples illustrating how to represent these concepts in SDTM, see Section 3.1.3.1, Harmful and Potentially Harmful Constituents (HPHCs) and Smoking Regimens.
  • Details of the three storage conditions are represented in the ES dataset example that follows below.

...

dataset

...

dataset-wrap
Namept
Rowcaps
Rows 1-9:

Show the

PTTEST

results of

Product Moisture for Condition 1 which is shown in STOCONID. The sample of various timepoints that may be used in the testing for product moisture is reflected in PTTPT. The PTTPTNUM shows the numerical version of the planned timepoint.  The REPNUM shows the incidence number of a test that is repeated within a given timeframe for the same test.

testing 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 PTTEST results of Product Moisture for Condition 2 across the same timepoints shown for Condition 1testing 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 842
5TOB07PTSmokeless01Condition 1115PRODMSTMOISTCTTProduct Moisture Content51.75%0.151.7551.75%TLT07_V1TPT LABCOTOBACCOAS-IS0.12203-29-2023Week 842
6TOB07PTSmokeless01Condition 1116PRODMSTMOISTCTTProduct Moisture Content51.67%0.151.6751.67%TLT07_V1TPT LABCOTOBACCOAS-IS0.12303-29-2023Week 842
7TOB07PTSmokeless01Condition 1117PRODMSTMOISTCTTProduct Moisture Content52.05%0.152.0552.05%TLT07_V1TPT LABCOTOBACCOAS-IS0.121Week 4807-19-2023Week 2439
8TOB07PTSmokeless01Condition 1118PRODMSTMOISTCTTProduct Moisture Content52.68%0.152.6852.68%TLT07_V1TPT LABCOTOBACCOAS-IS0.122Week 4807-19-2023Week 2439
9TOB07PTSmokeless01Condition 1119PRODMSTMOISTCTTProduct Moisture Content52.21%0.152.2152.21%TLT07_V1TPT LABCOTOBACCOAS-IS0.12307-19-2023Week 482493
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 842
14TOB07PTSmokeless01Condition 2124PRODMSTMOISTCTTProduct Moisture Content51.77%0.151.7751.77%TLT07_V1TPT LABCOTOBACCOAS-IS0.12203-29-2023Week 842
15TOB07PTSmokeless01Condition 2125PRODMSTMOISTCTTProduct Moisture Content51.84%0.151.8451.84%TLT07_V1TPT LABCOTOBACCOAS-IS0.12303-29-2023Week 842
16TOB07PTSmokeless01Condition 2126PRODMSTMOISTCTTProduct Moisture Content52.18%0.152.1852.18%TLT07_V1TPT LABCOTOBACCOAS-IS0.12107-19-2023Week 482493
17TOB07PTSmokeless01Condition 2127PRODMSTMOISTCTTProduct Moisture Content52.21%0.152.2152.21%TLT07_V1TPT LABCOTOBACCOAS-IS0.122Week 4807-19-2023Week 2439
18TOB07PTSmokeless01Condition 2128PRODMSTMOISTCTTProduct Moisture Content51.87%0.151.8751.87%TLT07_V1TPT LABCOTOBACCOAS-IS0.123Week 4807-19-2023Week 2439

Details of the storage conditions are represented in the Environmental Storage Conditions (ES) dataset. The variable STOCONID/Storage Condition ID represents the storage condition and links to the PT datasets above by matching values of STOCONID there. Each of the parameters defining that storage condition are represented in ESPARMCD/ESPARM, with values and units shown in ESVAL/ESVALU. The es.xpt ES dataset below shows all three both sets of storage conditions used across both pt.xpt of the PT dataset examples above..

Dataset wrap
Namees
Dataset2
RowSTUDYIDDOMAINSTOCONIDESSEQESPARMCDESPARMESVALESVALU
1

TOB07

ESCondition 11HUMIDHumidity37%
2

TOB07

ESCondition 12TEMPTemperature24C
3

TOB07

ESCondition 21HUMIDHumidity85%
4

TOB07

ESCondition 22TEMPTemperature27C