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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 their 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 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

Shelf life study has a protocol and provides the results of shelf life studies of tobacco 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 smokeless tobacco products for one testing condition at one timepoint and one replicate. The second table has one analyte and two test conditions for many time points and replicates.

...

  • .
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

PTTSTCND which is

STOCONID (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, 8-129:

Show the other analytes

used

measured in testing

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

.

) using the PTTEST and PTTESTCD variables.

PRODMST
Dataset2
RowSTUDYIDDOMAINSPTOBIDSTOCONIDPTSEQ
PTREFID
PTTESTCDPTTESTPTTSTDTLPTCATPTORRESPTORRESUPTLLODPTSTRESCPTSTRESNPTSTRESU
PTSPEC
PTXFN
PTSPCCND
PTNAM
PTMETHOD
PTSPECPTLLOQPTREPNUMPTDTCPTTPTPTTPTNUM
1TOB07PTSmokeless01Condition 11
TOB77777.1
MOISTCTT
Product
Moisture Content
STABILITY
STUDY
TESTING52.0%0.152.052.0%

TLT07_V1

TPT LABCOTOBACCO0.12102-01-2023Week 01
2TOB07PTSmokeless01Condition 12
TOB77777.1
PHpH
STABILITY
STUDY
TESTING8.06

8.068.06
TL009_V1TPT LABCOTOBACCO
102-01-2023Week 01
3TOB07PTSmokeless01Condition 13
TOB77777.1
H2OACTWater Activity
STABILITY
STUDY
TESTING0.86
0.010.860.86
TLPH01_V1TPT LABCOTOBACCO0.05102-01-2023Week 01
4TOB07PTSmokeless01Condition 14
TOB77777.1
NNK
4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK)
Nicotine-Derived Nitrosamine Ketone
STABILITY TESTING
STABILITY STUDY
1.0225ug/g0.011.02251.0225ug/gTL026_V12.2TPT LABCOTOBACCO
, FRESHAS-IS
0.05102-01-2023
1
Week 01
5TOB07PTSmokeless01Condition 15
TOB77777.1
NNK
4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK)
Nicotine-Derived Nitrosamine KetoneDRY WEIGHT BASISSTABILITY TESTING
STABILITY STUDY
0.4908ug/g0.010.49080.4908ug/gTL026_V12.2TPT LABCOTOBACCO
, DRIED
0.05
DRY WEIGHT
102-01-2023Week 01
6TOB07PTSmokeless01Condition 16
TOB77777.1
NNNN-
nitrosonornicotine
Nitrosonornicotine
STABILITY
STUDY
TESTING4.4633ug/g0.014.46334.4633ug/gTL026_V12.2TPT LABCOTOBACCO
, FRESHAS-IS
0.05102-01-2023
1
Week 01
7TOB07PTSmokeless01Condition 17
TOB77777.1
NNNN-
nitrosonornicotine
NitrosonornicotineDRY WEIGHT BASISSTABILITY
STUDY
TESTING2.1424ug/g0.012.14242.1424ug/gTL026_V12.2TPT LABCOTOBACCO
, DRIEDDRY WEIGHT
0.05102-01-2023Week 01
10
8TOB07PTSmokeless01Condition 18
TOB77777.1
AEBCT
AEBPLCT
Aerobic
Plate
Colony Count
STABILITY
STUDY
TESTING154000CFU/g1154000154000CFU/gTLMB_V1.1TPT LABCOTOBACCO1102-01-2023Week 01
11
9TOB07PTSmokeless01Condition 19
TOB77777.1TYMCTotal
YSTMLDCTYeast and/or Mold Colony Count
STABILITY
STUDY
TESTING<10CFU/g
<10
1<10
CFU/gTLMB_V1.1TPT LABCOTOBACCO1102-01-2023Week 01

*DWB=Dry weight basis. The DWB normalizes the results since starting moisture may vary.

...

Info

The second PT dataset shows testing for just 1 parameter (Moisture 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. 

Note
  • Details of the storage conditions are represented in the ES dataset example that follows.
Dataset wrap
Namept
Rowcaps
Rows 1-9:

Show the

PTTEST

results of

Product Moisture for Condition 1 which is shown in PTTSTCND. 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 1.  The PTGRPID is used to tie together a block of related records in a single domain.testing Moisture Content in 3 replicates (PTREPNUM) at 3 timepoints (weeks 0, 8, and 24) under the storage "Condition 2" (STOCONID). 
Dataset2
RowSTUDYIDDOMAINSPTOBIDSTOCONIDPTSEQPTREFIDPTTESTCDPTTESTPTORRESPTORRESUPTLLODPTSTRESCPTSTRESNPTSTRESUPTXFNPTNAMPTSPECPTSPCCNDPTMETHODPTLLOQPTREPNUMPTDTCPTTPTPTTPTNUM
1TOB07PTSmokeless01Condition 1111TOB77777.1PRODMSTMOISTCTTMoisture ContentProduct Moisture51.93%0.151.9351.93%TLT07_V1TPT LABCOTOBACCOAS-IS0.12102-01-2023Week 01
2TOB07PTSmokeless01Condition 1112TOB77777.1PRODMSTMOISTCTTProduct Moisture Content51.96%0.151.9651.96%TLT07_V1TPT LABCOTOBACCOAS-IS0.12202-01-2023Week 01
3TOB07PTSmokeless01Condition 1113TOB77777.1PRODMSTMOISTCTTProduct Moisture Content51.98%0.151.9851.98%TLT07_V1TPT LABCOTOBACCOAS-IS0.12302-01-2023Week 01
4TOB07PTSmokeless01Condition 1114TOB77777.1PRODMSTMOISTCTTProduct Moisture Content51.75%0.151.7551.75%TLT07_V1TPT LABCOTOBACCOAS-IS0.12103-29-2023Week 842
5TOB07PTSmokeless01Condition 1115TOB77777.1PRODMSTMOISTCTTMoisture ContentProduct Moisture51.75%0.151.7551.75%TLT07_V1TPT LABCOTOBACCOAS-IS0.12203-29-2023Week 842
6TOB07PTSmokeless01Condition 1116TOB77777.1PRODMSTMOISTCTTProduct Moisture Content51.67%0.151.6751.67%TLT07_V1TPT LABCOTOBACCOAS-IS0.12303-29-2023Week 842
7TOB07PTSmokeless01Condition 1117TOB77777.1PRODMSTMOISTCTTProduct Moisture Content52.05%0.152.0552.05%TLT07_V1TPT LABCOTOBACCOAS-IS0.121Week 4807-19-2023Week 2439
8TOB07PTSmokeless01Condition 1118TOB77777.1PRODMSTMOISTCTTProduct Moisture Content52.68%0.152.6852.68%TLT07_V1TPT LABCOTOBACCOAS-IS0.12207-19-2023Week 482493
9TOB07PTSmokeless01Condition 1119TOB77777.1PRODMSTMOISTCTTProduct Moisture Content52.21%0.152.2152.21%TLT07_V1TPT LABCOTOBACCOAS-IS0.12307-19-2023Week 482493
10TOB07PTSmokeless01Condition 2120TOB77777.1PRODMSTMOISTCTTMoisture ContentProduct Moisture51.93%0.151.9351.93%TLT07_V1TPT LABCOTOBACCOAS-IS0.12102-01-2023Week 01
11TOB07PTSmokeless01Condition 2121TOB77777.1PRODMSTMOISTCTTMoisture ContentProduct Moisture51.96%0.151.9651.96%TLT07_V1TPT LABCOTOBACCOAS-IS0.12202-01-2023Week 01
12TOB07PTSmokeless01Condition 2122TOB77777.1PRODMSTMOISTCTTProduct Moisture Content51.98%0.151.9851.98%TLT07_V1TPT LABCOTOBACCOAS-IS0.12302-01-2023Week 01
13TOB07PTSmokeless01Condition 2123TOB77777.1PRODMSTMOISTCTTProduct Moisture Content51.80%0.151.8051.80%TLT07_V1TPT LABCOTOBACCOAS-IS0.12103-29-2023Week 842
14TOB07PTSmokeless01Condition 2124TOB77777.1PRODMSTMOISTCTTProduct Moisture Content51.77%0.151.7751.77%TLT07_V1TPT LABCOTOBACCOAS-IS0.12203-29-2023Week 842
15TOB07PTSmokeless01Condition 2125TOB77777.1PRODMSTMOISTCTTProduct Moisture Content51.84%0.151.8451.84%TLT07_V1TPT LABCOTOBACCOAS-IS0.12303-29-2023Week 842
16TOB07PTSmokeless01Condition 2126TOB77777.1PRODMSTMOISTCTTProduct Moisture Content52.18%0.152.1852.18%TLT07_V1TPT LABCOTOBACCOAS-IS0.12107-19-2023Week 482493
17TOB07PTSmokeless01Condition 2127TOB77777.1PRODMSTMOISTCTTProduct Moisture Content52.21%0.152.2152.21%TLT07_V1TPT LABCOTOBACCOAS-IS0.12207-19-2023Week 482493
18TOB07PTSmokeless01Condition 2128TOB77777.1PRODMSTMOISTCTTMoisture ContentProduct Moisture51.87%0.151.8751.87%TLT07_V1TPT LABCOTOBACCOAS-IS0.12307-19-2023Week 482493

The storage conditions details of "E-Liquid Standard (Long Term) Condition 1" and "E-Liquid Standard (Long Term) Condition 1" 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 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 dataset shows both sets of storage conditions used across both of the PT dataset examples.

Dataset wrap
Namees
Dataset2
RowSTUDYIDDOMAINSTOCONIDESSEQESPARMCDESPARMESVALESVALU
1

TOB07

ESCondition 11HUMIDHumidity37%
2

TOB07

ESCondition
2
12TEMPTemperature24C
3

TOB07

ESCondition
1
21HUMIDHumidity85%
4

TOB07

ESCondition 22TEMPTemperature27C