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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.

...

Show the analytes used
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".
explain the spec condition and as-is and DWB  - NNN-as is  an NNN-DWB

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:Show the NNK and NNN tests with the results from the tobacco product as tested.
Rows 5, 7:Show the NNK and NNN test results as dry weight basis (DWB). Note the use of PTTSTDTL = "DRY WEIGHT BASIS"
Rows 2-3, 8-9:

Show the other analytes measured

Rows 2-12:

in testing.

Dataset2
RowSTUDYIDDOMAINSPTOBID
LBSEQ
STOCONID
LBREFID
PTSEQ
LBSPID
PTTESTCD
LBTESTCD
PTTEST
LBTEST
PTTSTDTL
LBTSTCND
PTCAT
LBORRES
PTORRES
LBORRESU
PTORRESU
LBSTRESC
PTLLOD
LBSTRESN
PTSTRESC
LBSTRESU
PTSTRESN
LBSPEC
PTSTRESU
LBSPCCND
PTXFN
LBMETHOD
PTNAM
LBANMETH
PTSPEC
LBTMTHSN
PTLLOQ
LBSTNRC
PTREPNUM
LBREPNUM
PTDTC
LBTPT
PTTPT
LBTPTNUM
PTTPTNUM
1TOB07
LB
PTSmokeless01Condition 11
PRODMST
MOISTCTT
Product
Moisture
Condition 1 (X°C/ Z% RH)%%TOBACCO PRODUCTFRESH1
Content
STABILITY TESTING52.0%0.152.052.0%

TLT07_V1

TPT LABCOTOBACCO0.12102-01-2023Week 01
2TOB07
LB
PTSmokeless01Condition 12PHpH
Acidity or alkalintyCondition 1 (X°C/ Z% RH)TOBACCO PRODUCTFRESH

STABILITY TESTING8.06

8.068.06
TL009_V1TPT LABCOTOBACCO
102-01-2023
1
Week 01
3TOB07
LB
PTSmokeless01Condition 13H2OACTWater Activity
Condition 1 (X°C/ Z% RH)TOBACCO PRODUCTFRESH

STABILITY TESTING0.86
0.010.860.86
TLPH01_V1TPT LABCOTOBACCO0.05102-01-2023
1
Week 01
4TOB07
LB
PTSmokeless01Condition 14NNK
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
PTSmokeless01Condition 15NNK
Condition 1 (X°C/ Z% RH)ng/gng/gTOBACCO PRODUCTDRIED
Nicotine-Derived Nitrosamine KetoneDRY WEIGHT BASISSTABILITY TESTING0.4908ug/g0.010.49080.4908ug/gTL026_V12.2TPT LABCOTOBACCO0.05102-01-2023
1
Week 01
6TOB07
PTSmokeless01Condition 1
LB
6NNN
Condition 1 (X°C/ Z% RH)ng/gng/gTOBACCO PRODUCTFRESH1
N-Nitrosonornicotine
STABILITY TESTING4.4633ug/g0.014.46334.4633ug/gTL026_V12.2TPT LABCOTOBACCO0.05102-01-2023Week 01
7TOB07
PTSmokeless01Condition 1
LB
7NNN
-DWBCondition 1 (X°C/ Z% RH)ng/gng/gTOBACCO PRODUCTDRIED1Week 018TOB07LB8TSNA -as isCondition 1 (X°C/ Z% RH)ng/gng/gTOBACCO PRODUCTFRESH
N-NitrosonornicotineDRY WEIGHT BASISSTABILITY TESTING2.1424ug/g0.012.14242.1424ug/gTL026_V12.2TPT LABCOTOBACCO0.05102-01-2023
1
Week 01
9
8TOB07
LB9
PTSmokeless01
TSNA -DWB
Condition 1
(X°C/ Z% RH)ng/gng/gTOBACCO PRODUCTDRIED1Week 0110TOB07LB10Aerobic Plate CountCondition 1 (X°C/ Z% RH)TOBACCO PRODUCTFRESH
8AEBCTAerobic Colony Count
STABILITY TESTING154000CFU/g1154000154000CFU/gTLMB_V1.1TPT LABCOTOBACCO1102-01-2023
1
Week 01
11
9TOB07
LBMold
PT
11
Smokeless01Condition 1
(X°C/ Z% RH)TOBACCO PRODUCTFRESH1Week 0112TOB07LB12YeastCondition 1 (X°C/ Z% RH)TOBACCO PRODUCTFRESH1Week 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.

...

9YSTMLDCTYeast and/or Mold Colony Count
STABILITY TESTING<10CFU/g1<10
CFU/gTLMB_V1.1TPT LABCOTOBACCO1102-01-2023Week 01
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). 
Dataset2
RowSTUDYIDDOMAINSPTOBID
LBSEQ
STOCONID
LBREFID
PTSEQ
LBTESTCD
PTTESTCD
LBTEST
PTTEST
LBTSTCND
PTORRES
LBORRES
PTORRESU
LBORRESU
PTLLOD
LBSTRESC
PTSTRESC
LBSTRESN
PTSTRESN
LBSTRESU
PTSTRESU
LBSPEC
PTXFN
LBSPCCND
PTNAM
LBMETHOD
PTSPEC
LBANMETH
PTSPCCND
LBTMTHSN
PTLLOQ
LBSTNRC
PTREPNUM
LBREPNUM
PTDTC
LBTPT
PTTPT
LBTPTNUM
PTTPTNUM
1TOB07
LB
PTSmokeless01Condition 1
TOB77777.1
111
PRODMST
MOISTCTT
Product
Moisture
Condition 1 (X°C/ Z% RH)%%TOBACCO PRODUCTFRESH1
Content51.93%0.151.9351.93%TLT07_V1TPT LABCOTOBACCOAS-IS0.12102-01-2023Week 01
2TOB07
LB
PT
2
Smokeless01
TOB77777.
Condition 1112
PRODMST
MOISTCTT
Product
Moisture
Condition 1 (X°C/ Z% RH)%%TOBACCO PRODUCTFRESH2
Content51.96%0.151.9651.96%TLT07_V1TPT LABCOTOBACCOAS-IS0.12202-01-2023Week 01
3TOB07
LB
PT
3
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
4
Smokeless01
TOB77777.
Condition 1
PRODMST
114MOISTCTT
Product
Moisture
Condition 1 (X°C/ Z% RH)%%TOBACCO PRODUCTFRESH
Content51.75%0.151.7551.75%TLT07_V1TPT LABCOTOBACCOAS-IS0.12103-29-2023
1
Week 8
4
2
5TOB07
LB
PT
5
Smokeless01
TOB77777.
Condition 1
PRODMST
115MOISTCTT
Product
Moisture
Condition 1 (X°C/ Z% RH)%%TOBACCO PRODUCTFRESH
Content51.75%0.151.7551.75%TLT07_V1TPT LABCOTOBACCOAS-IS0.12203-29-2023
2
Week 8
4
2
6TOB07
LB
PT
6
Smokeless01
TOB77777.
Condition 1116
PRODMST
MOISTCTT
Product
Moisture
Condition 1 (X°C/ Z% RH)%%TOBACCO PRODUCTFRESH3Week 8
Content51.67%0.151.6751.67%TLT07_V1TPT LABCOTOBACCOAS-IS0.12303-29-2023Week 82
4
7TOB07
LB
PT
7
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
8
Smokeless01
TOB77777.
Condition 1118
PRODMST
MOISTCTT
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
9
Smokeless01
TOB77777.
Condition 1
PRODMST
119MOISTCTT
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
10TOB07PT
LB
Smokeless01
10TOB77777.1PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)%%TOBACCO PRODUCTFRESH
Condition 2120MOISTCTTMoisture Content51.93%0.151.9351.93%TLT07_V1TPT LABCOTOBACCOAS-IS0.12102-01-2023
1
Week 01
11TOB07
LB11TOB77777.1PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)%%TOBACCO PRODUCTFRESH2
PTSmokeless01Condition 2121MOISTCTTMoisture Content51.96%0.151.9651.96%TLT07_V1TPT LABCOTOBACCOAS-IS0.12202-01-2023Week 01
12TOB07PT
LB
Smokeless01
12TOB77777.1PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)%%TOBACCO PRODUCTFRESH3
Condition 2122MOISTCTTMoisture Content51.98%0.151.9851.98%TLT07_V1TPT LABCOTOBACCOAS-IS0.12302-01-2023Week 01
13TOB07PTSmokeless01Condition 2123MOISTCTTMoisture Content51.80%0.151.8051.80%TLT07_V1TPT LABCOTOBACCOAS-IS0.12103-29-2023Week 82
14TOB07PTSmokeless01Condition 2124MOISTCTTMoisture Content51.77%0.151.7751.77%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