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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 tobacco products for one testing condition at one timepoint and one replicate.

...

Dataset wrap
Namelbpt
Rowcaps
Row 1:

Shows the

LBTEST

PTTEST of

Product

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

LBTSTCND which is

STOCONID (i.e., Condition 1

(X°C/ Z% RH

). 

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:Shows Show the NNK , and NNN , and TSN tests with the results from the tobacco product "as-is" using the LBSPCCND to show that the tobacco is "FRESH"as tested.
Rows 5, 7, 9:Shows Show the NNK , NNN, and TSN tests with the tobacco product as "Dry and NNN test results as dry weight basis (DWB)" using the LBSPCCND to show that the tobacco is "DRIED".. Note the use of PTTSTDTL = "DRY WEIGHT BASIS"
Rows 2-123, 8-9:

Show the other analytes

used

measured in testing

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

.

) using the LBTEST and LBTESTCD variables.

LBTPTNUM
Dataset2
RowSTUDYIDDOMAIN
LBSEQLBREFIDLBTESTCDLBTESTLBTSTCNDLBORRESLBORRESULBSTRESCLBSTRESNLBSTRESULBSPECLBSPCCNDLBMETHODLBREPNUMLBTPT
SPTOBIDSTOCONIDPTSEQPTTESTCDPTTESTPTTSTDTLPTCATPTORRESPTORRESUPTLLODPTSTRESCPTSTRESNPTSTRESUPTXFNPTNAMPTSPECPTLLOQPTREPNUMPTDTCPTTPTPTTPTNUM
1TOB07PT
LB
Smokeless01Condition 1
TOB77777.
1
PRODMST
MOISTCTT
Product MoistureCondition 1 (X°C/ Z% RH)%%TOBACCO PRODUCTFRESH1
Moisture Content
STABILITY TESTING52.0%0.152.052.0%

TLT07_V1

TPT LABCOTOBACCO0.12102-01-2023Week 01
2TOB07
LB
PT
2
Smokeless01
TOB77777.
Condition 12PHpH
Condition 1 (X°C/ Z% RH)TOBACCO PRODUCTFRESH

STABILITY TESTING8.06

8.068.06
TL009_V1TPT LABCOTOBACCO
102-01-2023
1
Week 01
3TOB07
LB
PT
3
Smokeless01
TOB77777.
Condition 13H2OACTWater Activity
Condition 1 (X°C/ Z% RH)TOBACCO PRODUCTFRESH1

STABILITY TESTING0.86
0.010.860.86
TLPH01_V1TPT LABCOTOBACCO0.05102-01-2023Week 01
4TOB07
LB
PT
4
Smokeless01
TOB77777.
Condition 14NNK
4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK)Condition 1 (X°C/ Z% RH)ng/gng/gTOBACCO PRODUCTFRESH
Nicotine-Derived Nitrosamine Ketone
STABILITY TESTING1.0225ug/g0.011.02251.0225ug/gTL026_V12.2TPT LABCOTOBACCO0.05102-01-2023
1
Week 01
5TOB07
LB
PT
5
Smokeless01
TOB77777.
Condition 15NNK
4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK)Condition 1 (X°C/ Z% RH)ng/gng/gTOBACCO PRODUCTDRIED1
Nicotine-Derived Nitrosamine KetoneDRY WEIGHT BASISSTABILITY TESTING0.4908ug/g0.010.49080.4908ug/gTL026_V12.2TPT LABCOTOBACCO0.05102-01-2023Week 01
6TOB07
LB
PT
6
Smokeless01
TOB77777.
Condition 16NNNN-
nitrosonornicotineCondition 1 (X°C/ Z% RH)ng/gng/gTOBACCO PRODUCTFRESH1
Nitrosonornicotine
STABILITY TESTING4.4633ug/g0.014.46334.4633ug/gTL026_V12.2TPT LABCOTOBACCO0.05102-01-2023Week 01
7TOB07
LB
PT
7
Smokeless01
TOB77777.
Condition 17NNNN-
nitrosonornicotineCondition 1 (X°C/ Z% RH)ng/gng/gTOBACCO PRODUCTDRIED1Week 018TOB07LB8TOB77777.1TSNATobacco-specific nitrosaminesCondition 1 (X°C/ Z% RH)ng/gng/gTOBACCO PRODUCTFRESH1
NitrosonornicotineDRY WEIGHT BASISSTABILITY TESTING2.1424ug/g0.012.14242.1424ug/gTL026_V12.2TPT LABCOTOBACCO0.05102-01-2023Week 01
9
8TOB07
LB
PT
9
Smokeless01
TOB77777.10TOB07LB10TOB77777.1AEBPLCTAerobic Plate CountCondition 1 (X°C/ Z% RH)TOBACCO PRODUCTFRESH1
Condition 18
TSNATobacco-specific nitrosaminesCondition 1 (X°C/ Z% RH)ng/gng/gTOBACCO PRODUCTDRIED1Week 01
AEBCTAerobic Colony Count
STABILITY TESTING154000CFU/g1154000154000CFU/gTLMB_V1.1TPT LABCOTOBACCO1102-01-2023
Week 01
11
9TOB07
LB
PT
11
Smokeless01
TOB77777.
Condition 1
MOLD
9
MoldCondition 1 (X°C/ Z% RH)TOBACCO PRODUCTFRESH1Week 01
YSTMLDCTYeast and/or Mold Colony Count
STABILITY TESTING<10CFU/g1<10
CFU/gTLMB_V1.1TPT LABCOTOBACCO1102-01-2023
12TOB07LB12TOB77777.1YEASTYeastCondition 1 (X°C/ Z% RH)TOBACCO PRODUCTFRESH1
Week 01

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

Make sure LOQ is in the dataset - it is important.

...

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
Namelbpt
Rowcaps
Rows 1-9:

Show the

LBTEST

results of

Product Moisture for Condition 1 (X°C/ Z% RH) which is shown in LBTSTCND. The sample of various timepoints that may be used in the testing for product moisture is reflected in LBTPT. The LBTPTNUM 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 LBTEST results of Product Moisture for Condition 2 Condition 2 (A °C/ B %RH) across the same timepoints shown for Condition 1.  The LBGRPID 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). 
LBTPTNUM
Dataset2
RowSTUDYIDDOMAIN
LBSEQLBREFIDLBTESTCDLBTESTLBTSTCNDLBORRESLBORRESULBSTRESCLBSTRESNLBSTRESULBSPECLBSPCCNDLBMETHODLBREPNUMLBTPT
SPTOBIDSTOCONIDPTSEQPTTESTCDPTTESTPTORRESPTORRESUPTLLODPTSTRESCPTSTRESNPTSTRESUPTXFNPTNAMPTSPECPTSPCCNDPTLLOQPTREPNUMPTDTCPTTPTPTTPTNUM
1TOB07
LB
PT
111
Smokeless01
TOB77777.
Condition 1111
PRODMST
MOISTCTT
Product
Moisture
Condition 1 (X°C/ Z% RH)%%TOBACCO PRODUCTFRESH
Content51.93%0.151.9351.93%TLT07_V1TPT LABCOTOBACCOAS-IS0.12102-01-2023
1
Week 01
2TOB07
LB
PT
112
Smokeless01
TOB77777.
Condition 1
PRODMST
112MOISTCTT
Product
Moisture
Condition 1 (X°C/ Z% RH)%%TOBACCO PRODUCTFRESH
Content51.96%0.151.9651.96%TLT07_V1TPT LABCOTOBACCOAS-IS0.12202-01-2023
2
Week 01
3TOB07
LB
PT
113
Smokeless01
TOB77777.
Condition 1
PRODMST
113MOISTCTT
Product
Moisture
Condition 1 (X°C/ Z% RH)%%TOBACCO PRODUCTFRESH
Content51.98%0.151.9851.98%TLT07_V1TPT LABCOTOBACCOAS-IS0.12302-01-2023
3
Week 01
4TOB07
LB
PT
114
Smokeless01
TOB77777.
Condition 1
PRODMST
114MOISTCTT
Product
Moisture
Condition 1 (X°C/ Z% RH)%%TOBACCO PRODUCTFRESH1Week 8
Content51.75%0.151.7551.75%TLT07_V1TPT LABCOTOBACCOAS-IS0.12103-29-2023Week 82
4
5TOB07
LB
PT
115
Smokeless01
TOB77777.
Condition 1115
PRODMST
MOISTCTT
Product
Moisture
Condition 1 (X°C/ Z% RH)%%TOBACCO PRODUCTFRESH2Week 8
Content51.75%0.151.7551.75%TLT07_V1TPT LABCOTOBACCOAS-IS0.12203-29-2023Week 82
4
6TOB07
LB
PT
116
Smokeless01
TOB77777.
Condition 1
PRODMST
116MOISTCTT
Product
Moisture
Condition 1 (X°C/ Z% RH)%%TOBACCO PRODUCTFRESH
Content51.67%0.151.6751.67%TLT07_V1TPT LABCOTOBACCOAS-IS0.12303-29-2023
3
Week 8
4
2
7TOB07
LB
PT
117
Smokeless01
TOB77777.
Condition 1117
PRODMST
MOISTCTT
Product
Moisture
Condition 1 (X°C/ Z% RH)%%TOBACCO PRODUCTFRESH1Week 48
Content52.05%0.152.0552.05%TLT07_V1TPT LABCOTOBACCOAS-IS0.12107-19-2023Week 243
9
8TOB07
LB
PT
118
Smokeless01
TOB77777.
Condition 1
PRODMST
118MOISTCTT
Product
Moisture
Condition 1 (X°C/ Z% RH)%%TOBACCO PRODUCTFRESH2Week 48
Content52.68%0.152.6852.68%TLT07_V1TPT LABCOTOBACCOAS-IS0.12207-19-2023Week 243
9
9TOB07
LB
PT
119
Smokeless01
TOB77777.
Condition 1119
PRODMST
MOISTCTT
Product
Moisture
Condition 1 (X°C/ Z% RH)%%TOBACCO PRODUCTFRESH3Week 48
Content52.21%0.152.2152.21%TLT07_V1TPT LABCOTOBACCOAS-IS0.12307-19-2023Week 243
9
10TOB07
PTSmokeless01Condition 2
LB
120
MOISTCTTMoisture Content51.93%0
TOB77777
.1
PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)%%TOBACCO PRODUCTFRESH1
51.9351.93%TLT07_V1TPT LABCOTOBACCOAS-IS0.12102-01-2023Week 01
11TOB07
LB
PTSmokeless01Condition 2121
MOISTCTTMoisture Content51.96%0
TOB77777
.1
PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)%%TOBACCO PRODUCTFRESH
51.9651.96%TLT07_V1TPT LABCOTOBACCOAS-IS0.12202-01-2023
2
Week 01
12TOB07
LB122
PTSmokeless01Condition 2122MOISTCTTMoisture Content51.98%0
TOB77777
.1
PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)%%TOBACCO PRODUCTFRESH3
51.9851.98%TLT07_V1TPT LABCOTOBACCOAS-IS0.12302-01-2023Week 01
13TOB07
LB123
PTSmokeless01Condition 2123MOISTCTTMoisture Content51.80%0
TOB77777
.1
PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)%%TOBACCO PRODUCTFRESH1Week 8
51.8051.80%TLT07_V1TPT LABCOTOBACCOAS-IS0.12103-29-2023Week 82
4
14TOB07
PTSmokeless01Condition 2
LB
124
MOISTCTTMoisture Content51.77%0
TOB77777
.151.7751.77%TLT07_V1TPT LABCOTOBACCOAS-IS0.12203-29-2023Week 82
15TOB07PTSmokeless01Condition 2125MOISTCTTMoisture Content51.84%0.151.8451.84%TLT07_V1TPT LABCOTOBACCOAS-IS0.12303-29-2023Week 82
16TOB07PTSmokeless01Condition 2126MOISTCTTMoisture Content52.18%0.152.1852.18%TLT07_V1TPT LABCOTOBACCOAS-IS0.12107-19-2023Week 243
17TOB07PTSmokeless01Condition 2127MOISTCTTMoisture Content52.21%0.152.2152.21%TLT07_V1TPT LABCOTOBACCOAS-IS0.12207-19-2023Week 243
18TOB07PTSmokeless01Condition 2128MOISTCTTMoisture Content51.87%0.151.8751.87%TLT07_V1TPT LABCOTOBACCOAS-IS0.12307-19-2023Week 243

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
9
Dataset2
RowSTUDYIDDOMAINSTOCONIDESSEQESPARMCDESPARMESVALESVALU
1

TOB07

ESCondition 11HUMIDHumidity37%
2

TOB07

ESCondition 12TEMPTemperature24C
3

TOB07

ESCondition 21HUMIDHumidity85%
4

TOB07

ESCondition 22TEMPTemperature27C
PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)%%TOBACCO PRODUCTFRESH2Week 8415TOB07LB125TOB77777.1PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)%%TOBACCO PRODUCTFRESH3Week 8416TOB07LB126TOB77777.1PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)%%TOBACCO PRODUCTFRESH1Week 48917TOB07LB127TOB77777.1PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)%%TOBACCO PRODUCTFRESH2Week 48918TOB07LB128TOB77777.1PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)%%TOBACCO PRODUCTFRESH3Week 48