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changes.mady.by.user Rebecca Baker

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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.

...

  • .
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".Rows 2-12

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

used

measured in testing.

LBTPTNUM
Dataset2
RowSTUDYIDDOMAIN
LBSEQLBREFIDLBSPIDLBTESTCDLBTESTLBTSTCNDLBORRESLBORRESULBSTRESCLBSTRESNLBSTRESULBMETHODLBANMETHLBTMTHSNLBSTNRCLBREPNUMLBTPT
SPTOBIDSTOCONIDPTSEQPTTESTCDPTTESTPTTSTDTLPTCATPTORRESPTORRESUPTLLODPTSTRESCPTSTRESNPTSTRESUPTXFNPTNAMPTSPECPTLLOQPTREPNUMPTDTCPTTPTPTTPTNUM
1TOB07
LB
PTSmokeless01Condition 11MOISTCTT
Product
Moisture
Condition 1 (X°C/ Z% RH)%%1
Content
STABILITY TESTING52.0%0.152.052.0%

TLT07_V1

TPT LABCOTOBACCO0.12102-01-2023Week 0
Week 1
1
2TOB07
TOB08
PTSmokeless01Condition 1
LB
2PHpH
Condition 1 (X°C/ Z% RH)1

STABILITY TESTING8.06

8.068.06
TL009_V1TPT LABCOTOBACCO
102-01-2023Week 0
Week 1
1
3
TOB09
TOB07PTSmokeless01Condition 1
LB
3H2OACTWater Activity
Condition 1 (X°C/ Z% RH)1

STABILITY TESTING0.86
0.010.860.86
TLPH01_V1TPT LABCOTOBACCO0.05102-01-2023Week 0
Week 1
1
4
TOB10
TOB07PTSmokeless01Condition 1
LB
4NNK
-as isCondition 1 (X°C/ Z% RH)ng/gng/g1
Nicotine-Derived Nitrosamine Ketone
STABILITY TESTING1.0225ug/g0.011.02251.0225ug/gTL026_V12.2TPT LABCOTOBACCO0.05102-01-2023Week 0
Week 1
1
5
TOB11
TOB07PTSmokeless01Condition 1
LB
5NNK
-DWB*Condition 1 (X°C/ Z% RH)ng/gng/g1
Nicotine-Derived Nitrosamine KetoneDRY WEIGHT BASISSTABILITY TESTING0.4908ug/g0.010.49080.4908ug/gTL026_V12.2TPT LABCOTOBACCO0.05102-01-2023Week 0
Week 1
1
6
TOB12
TOB07PTSmokeless01Condition 1
LB
6NNN
-as isCondition 1 (X°C/ Z% RH)ng/gng/g1Week 117TOB13LB7NNK-DWBCondition 1 (X°C/ Z% RH)ng/gng/g1Week 118TOB14LB8TSNA -as isCondition 1 (X°C/ Z% RH)ng/gng/g1Week 119TOB15LB9TSNA -DWBCondition 1 (X°C/ Z% RH)ng/gng/g1Week 1110TOB16LB10Aerobic Plate CountCondition 1 (X°C/ Z% RH)1Week 1111TOB17LB11MoldCondition 1 (X°C/ Z% RH)1Week 1112TOB18LB12YeastCondition 1 (X°C/ Z% RH)1Week 11

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

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

...

N-Nitrosonornicotine
STABILITY TESTING4.4633ug/g0.014.46334.4633ug/gTL026_V12.2TPT LABCOTOBACCO0.05102-01-2023Week 01
7TOB07PTSmokeless01Condition 17NNNN-NitrosonornicotineDRY WEIGHT BASISSTABILITY TESTING2.1424ug/g0.012.14242.1424ug/gTL026_V12.2TPT LABCOTOBACCO0.05102-01-2023Week 01
8TOB07PTSmokeless01Condition 18AEBCTAerobic Colony Count
STABILITY TESTING154000CFU/g1154000154000CFU/gTLMB_V1.1TPT LABCOTOBACCO1102-01-2023Week 01
9TOB07PTSmokeless01Condition 19YSTMLDCTYeast 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
LBGRPID
PTSEQ
LBREFID
PTTESTCD
LBSPID
PTTEST
LBTESTCD
PTORRES
LBTEST
PTORRESU
LBTSTCND
PTLLOD
LBORRES
PTSTRESC
LBORRESU
PTSTRESN
LBSTRESC
PTSTRESU
LBSTRESN
PTXFN
LBSTRESU
PTNAM
LBMETHOD
PTSPEC
LBANMETH
PTSPCCND
LBTMTHSN
PTLLOQ
LBSTNRC
PTREPNUM
LBREPNUM
PTDTC
LBTPT
PTTPT
LBTPTNUM
PTTPTNUM
1TOB07PT
LB
Smokeless01Condition 1111
1
MOISTCTT
Product
Moisture
Condition 1 (X°C/ Z% RH)%%1
Content51.93%0.151.9351.93%TLT07_V1TPT LABCOTOBACCOAS-IS0.12102-01-2023Week 01
2TOB07
LB
PT
2
Smokeless01Condition 1112MOISTCTT
Product
Moisture
Condition 1 (X°C/ Z% RH)%%
Content51.96%0.151.9651.96%TLT07_V1TPT LABCOTOBACCOAS-IS0.12202-01-2023
2
Week 01
3TOB07
LB
PT
3
Smokeless01Condition 1
Product MoistureCondition 1 (X°C/ Z% RH)%%3
113MOISTCTTMoisture Content51.98%0.151.9851.98%TLT07_V1TPT LABCOTOBACCOAS-IS0.12302-01-2023Week 01
4TOB07
LB
PT
4
Smokeless01Condition 1114MOISTCTT
Product
Moisture
Condition 1 (X°C/ Z% RH)%%1Week 8
Content51.75%0.151.7551.75%TLT07_V1TPT LABCOTOBACCOAS-IS0.12103-29-2023Week 82
4
5TOB07
LB
PT
5
Smokeless01Condition 1
Product MoistureCondition 1 (X°C/ Z% RH)%%2Week 8
115MOISTCTTMoisture Content51.75%0.151.7551.75%TLT07_V1TPT LABCOTOBACCOAS-IS0.12203-29-2023Week 82
4
6TOB07
LB
PT
6
Smokeless01Condition 1116
Product MoistureCondition 1 (X°C/ Z% RH)%%3Week 8
MOISTCTTMoisture Content51.67%0.151.6751.67%TLT07_V1TPT LABCOTOBACCOAS-IS0.12303-29-2023Week 82
4
7TOB07
LB
PT
7
Smokeless01Condition 1
Product MoistureCondition 1 (X°C/ Z% RH)%%1Week 48
117MOISTCTTMoisture Content52.05%0.152.0552.05%TLT07_V1TPT LABCOTOBACCOAS-IS0.12107-19-2023Week 243
9
8TOB07
LB
PT
8
Smokeless01Condition 1118
Product MoistureCondition 1 (X°C/ Z% RH)%%2Week 48
MOISTCTTMoisture Content52.68%0.152.6852.68%TLT07_V1TPT LABCOTOBACCOAS-IS0.12207-19-2023Week 243
9
9TOB07
LB
PT
9
Smokeless01Condition 1
Product MoistureCondition 1 (X°C/ Z% RH)%%3Week 48
119MOISTCTTMoisture Content52.21%0.152.2152.21%TLT07_V1TPT LABCOTOBACCOAS-IS0.12307-19-2023Week 243
9
10TOB07
LB
PT
10
Smokeless01Condition 2
Product
120MOISTCTTMoisture
Condition 2 (A °C/ B %RH)
Content51.93%0.151.9351.93%TLT07_V1TPT LABCOTOBACCOAS-IS0.12102-01-2023Week 01
11TOB07
LB
PT
11
Smokeless01Condition 2121
Product
MOISTCTTMoisture
Condition 2 (A °C/ B %RH)%%2
Content51.96%0.151.9651.96%TLT07_V1TPT LABCOTOBACCOAS-IS0.12202-01-2023Week 01
12TOB07
LB
PT
12
Smokeless01Condition 2122MOISTCTT
Product
Moisture
Condition 2 (A °C/ B %RH)%%3
Content51.98%0.151.9851.98%TLT07_V1TPT LABCOTOBACCOAS-IS0.12302-01-2023Week 01
13TOB07
LB
PT
13
Smokeless01Condition 2123MOISTCTT
Product
Moisture
Content51.80
Condition 2 (A °C/ B %RH)
%0.151.8051.80%TLT07_V1TPT LABCOTOBACCOAS-IS0.12103-29-2023Week 8
4
2
14TOB07
LB
PT
14
Smokeless01Condition 2
Product
124MOISTCTTMoisture
Content51.77
Condition 2 (A °C/ B %RH)
%0.151.7751.77%TLT07_V1TPT LABCOTOBACCOAS-IS0.12203-29-2023Week 8
4
2
15TOB07
LB
PT
15
Smokeless01Condition 2
Product
125MOISTCTTMoisture
Content51.84
Condition 2 (A °C/ B %RH)
%0.151.8451.84%TLT07_V1TPT LABCOTOBACCOAS-IS0.12303-29-2023Week 8
4
2
16TOB07
LB
PT
16
Smokeless01Condition 2
Product
126MOISTCTTMoisture
Condition 2 (A °C/ B %RH)%%1Week 48
Content52.18%0.152.1852.18%TLT07_V1TPT LABCOTOBACCOAS-IS0.12107-19-2023Week 243
9
17TOB07
LB
PT
17
Smokeless01Condition 2
Product
127MOISTCTTMoisture
Condition 2 (A °C/ B %RH)%%2Week 48
Content52.21%0.152.2152.21%TLT07_V1TPT LABCOTOBACCOAS-IS0.12207-19-2023Week 243
9
18TOB07
LB
PT
18
Smokeless01Condition 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
Product MoistureCondition 2 (A °C/ B %RH)%%3Week 48