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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.

  • 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.

Row 1:

Shows the PTTEST of Product Moisture TOBA-111 - Jira project doesn't exist or you don't have permission to view it. TOBA-200 - Jira project doesn't exist or you don't have permission to view it. which reflects the percentage of moisture in the substance for the condition noted in STOCONID which is Condition 1. Product Moisture is used in chemistry stability studies. For microbial stability studies, Water Activity should be used, not Product Moisture (see Row 3).

Rows 4, 6, 8:Show the NNK, NNN, and TSN tests with the tobacco product "AS-IS" using the PTSPCCND to show that the tobacco is "FRESH".
Rows 5, 7, 9:Show the NNK, NNN, and TSN tests with the tobacco product as "DRY WEIGHT BASIS" (DWB) using the PTSPCCND to show that the tobacco is "DRIED".
Rows 2-11:

Show the other analytes used in testing (pH TOBA-110 - Jira project doesn't exist or you don't have permission to view it. , water activity, NNK, NNN, TSNA, etc.) using the PTTEST and PTTESTCD variables.

pt.xpt

pt.xpt

RowSTUDYIDDOMAINSPTOBIDSTOCONIDPTSEQPTTESTCDPTTESTPTCATPTORRESPTORRESUPTLLODPTSTRESCPTSTRESNPTSTRESUPTXFNPTNAMPTSPECPTSPCCNDPTLLOQPTREPNUMPTDTCPTTPTPTTPTNUM
1TOB07PTSmokeless01Condition 11PRODMSTProduct MoistureSTABILITY STUDY52.0%0.152.052.0%

TLT07_V1 TOBA-255 - Jira project doesn't exist or you don't have permission to view it.

TPT LABCOTOBACCO
0.12102-01-2023Week 01
2TOB07PTSmokeless01Condition 12PHpHSTABILITY STUDY8.06

8.068.06
TL009_V1TPT LABCOTOBACCO

102-01-2023Week 01
3TOB07PTSmokeless01Condition 13H2OACTWater ActivitySTABILITY STUDY0.86
0.010.860.86
TLPH01_V1TPT LABCOTOBACCO
0.05102-01-2023Week 01
4TOB07PTSmokeless01Condition 14NNKNicotine-Derived Nitrosamine KetoneSTABILITY STUDY1.0225ug/g0.011.02251.0225ug/gTL026_V12.2TPT LABCOTOBACCOAS-IS0.05102-01-2023Week 01
5TOB07PTSmokeless01Condition 15NNKNicotine-Derived Nitrosamine KetoneSTABILITY STUDY0.4908ug/g0.010.49080.4908ug/gTL026_V12.2TPT LABCOTOBACCODRIED0.05102-01-2023Week 01
6TOB07PTSmokeless01Condition 16NNNN-NitrosonornicotineSTABILITY STUDY4.4633ug/g0.014.46334.4633ug/gTL026_V12.2TPT LABCOTOBACCOAS-IS0.05102-01-2023Week 01
7TOB07PTSmokeless01Condition 17NNNN-NitrosonornicotineSTABILITY STUDY2.1424ug/g0.012.14242.1424ug/gTL026_V12.2TPT LABCOTOBACCODRIED0.05102-01-2023Week 01
10TOB07PTSmokeless01Condition 18AEBPLCTAerobic Plate CountSTABILITY STUDY154000CFU/g1154000154000CFU/gTLMB_V1.1TPT LABCOTOBACCO
1102-01-2023Week 01
11TOB07PTSmokeless01Condition 19TYMCTotal Yeast and/or Mold CountSTABILITY STUDY<10CFU/g1<10
CFU/gTLMB_V1.1TPT LABCOTOBACCO
1102-01-2023Week 01

Dataset Debug Message

When the JIRA issue(s) present in the dataset have been resolved, and their resolution has been confirmed by governance, please remove them.

Dataset Wrapper Debug Message

Please add a row column to your dataset.

The second pt.xpt dataset shows testing for just one parameter, product moisture, TOBA-157 - Getting issue details... STATUS 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. 

  • Details of the storage conditions are represented in the ES dataset example that follows below.

Rows 1-9:

Show the results of testing Product Moisture TOBA-108 - Jira project doesn't exist or you don't have permission to view it. in three replicates (PTREPNUM) at three timepoints (Week 0, Week 8, and Week 24) under the storage "Condition 1" (STOCONID).

Rows 10-18:Show the results of testing Product Moisture in three replicates (PTREPNUM) at three timepoints (Week 0, Week 8, and Week 24) under the storage "Condition 2" (STOCONID).

pt.xpt

pt.xpt

RowSTUDYIDDOMAINSPTOBIDSTOCONIDPTSEQPTTESTCDPTTESTPTORRESPTORRESUPTLLODPTSTRESCPTSTRESNPTSTRESUPTXFNPTNAMPTSPECPTSPCCNDPTLLOQPTREPNUMPTDTCPTTPTPTTPTNUM
1TOB07PTSmokeless01Condition 1111PRODMSTProduct Moisture51.93%0.151.9351.93%TLT07_V1TPT LABCOTOBACCOAS-IS0.12102-01-2023Week 01
2TOB07PTSmokeless01Condition 1112PRODMSTProduct Moisture51.96%0.151.9651.96%TLT07_V1TPT LABCOTOBACCOAS-IS0.12202-01-2023Week 01
3TOB07PTSmokeless01Condition 1113PRODMSTProduct Moisture51.98%0.151.9851.98%TLT07_V1TPT LABCOTOBACCOAS-IS0.12302-01-2023Week 01
4TOB07PTSmokeless01Condition 1114PRODMSTProduct Moisture51.75%0.151.7551.75%TLT07_V1TPT LABCOTOBACCOAS-IS0.12103-29-2023Week 82
5TOB07PTSmokeless01Condition 1115PRODMSTProduct Moisture51.75%0.151.7551.75%TLT07_V1TPT LABCOTOBACCOAS-IS0.12203-29-2023Week 82
6TOB07PTSmokeless01Condition 1116PRODMSTProduct Moisture51.67%0.151.6751.67%TLT07_V1TPT LABCOTOBACCOAS-IS0.12303-29-2023Week 82
7TOB07PTSmokeless01Condition 1117PRODMSTProduct Moisture52.05%0.152.0552.05%TLT07_V1TPT LABCOTOBACCOAS-IS0.12107-19-2023Week 243
8TOB07PTSmokeless01Condition 1118PRODMSTProduct Moisture52.68%0.152.6852.68%TLT07_V1TPT LABCOTOBACCOAS-IS0.12207-19-2023Week 243
9TOB07PTSmokeless01Condition 1119PRODMSTProduct Moisture52.21%0.152.2152.21%TLT07_V1TPT LABCOTOBACCOAS-IS0.12307-19-2023Week 243
10TOB07PTSmokeless01Condition 2120PRODMSTProduct Moisture51.93%0.151.9351.93%TLT07_V1TPT LABCOTOBACCOAS-IS0.12102-01-2023Week 01
11TOB07PTSmokeless01Condition 2121PRODMSTProduct Moisture51.96%0.151.9651.96%TLT07_V1TPT LABCOTOBACCOAS-IS0.12202-01-2023Week 01
12TOB07PTSmokeless01Condition 2122PRODMSTProduct Moisture51.98%0.151.9851.98%TLT07_V1TPT LABCOTOBACCOAS-IS0.12302-01-2023Week 01
13TOB07PTSmokeless01Condition 2123PRODMSTProduct Moisture51.80%0.151.8051.80%TLT07_V1TPT LABCOTOBACCOAS-IS0.12103-29-2023Week 82
14TOB07PTSmokeless01Condition 2124PRODMSTProduct Moisture51.77%0.151.7751.77%TLT07_V1TPT LABCOTOBACCOAS-IS0.12203-29-2023Week 82
15TOB07PTSmokeless01Condition 2125PRODMSTProduct Moisture51.84%0.151.8451.84%TLT07_V1TPT LABCOTOBACCOAS-IS0.12303-29-2023Week 82
16TOB07PTSmokeless01Condition 2126PRODMSTProduct Moisture52.18%0.152.1852.18%TLT07_V1TPT LABCOTOBACCOAS-IS0.12107-19-2023Week 243
17TOB07PTSmokeless01Condition 2127PRODMSTProduct Moisture52.21%0.152.2152.21%TLT07_V1TPT LABCOTOBACCOAS-IS0.12207-19-2023Week 243
18TOB07PTSmokeless01Condition 2128PRODMSTProduct Moisture51.87%0.151.8751.87%TLT07_V1TPT LABCOTOBACCOAS-IS0.12307-19-2023Week 243
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Dataset Wrapper Debug Message

Please add a row column to your dataset.

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 dataset below shows both sets of storage conditions used across both pt.xpt dataset examples above.

es.xpt

es.xpt

RowSTUDYIDDOMAINSTOCONIDESSEQESPARMCDESPARMESVALESVALU
1

TOB07

ESCondition 11HUMIDHumidity37%
2

TOB07

ESCondition 12TEMPTemperature24C
3

TOB07

ESCondition 21HUMIDHumidity85%
4

TOB07

ESCondition 22TEMPTemperature27C
$warningHtml

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