Versions Compared

Old Version 13

changes.mady.by.user Rebecca Baker

Saved on

compared with

New Version Current

changes.mady.by.user Christine Connolly

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
Info

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 11MOISTCTT
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
PTSmokeless01Condition 1
LB
2PHpH
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
PTSmokeless01Condition 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
PTSmokeless01Condition 14NNK
-as isCondition 1 (X°C/ Z% RH)ng/gng/gTOBACCO PRODUCTFRESH1
Nicotine-Derived Nitrosamine Ketone
STABILITY TESTING1.0225ug/g0.011.02251.0225ug/gTL026_V12.2TPT LABCOTOBACCO0.05102-01-2023Week 01
5TOB07
LB
PTSmokeless01Condition 15NNK
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
PTSmokeless01Condition 1
LB
6NNN
Condition 1 (X°C/ Z% RH)ng/gng/gTOBACCO PRODUCTFRESH
N-Nitrosonornicotine
STABILITY TESTING4.4633ug/g0.014.46334.4633ug/gTL026_V12.2TPT LABCOTOBACCO0.05102-01-2023
1
Week 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 PRODUCTFRESH1
N-NitrosonornicotineDRY WEIGHT BASISSTABILITY TESTING2.1424ug/g0.012.14242.1424ug/gTL026_V12.2TPT LABCOTOBACCO0.05102-01-2023Week 01
9
8TOB07
LB
PT
9
Smokeless01
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 01
9YSTMLDCTYeast and/or Mold Colony Count
STABILITY TESTING<10CFU/g1<10
CFU/gTLMB_V1.1TPT LABCOTOBACCO1102-01-2023
12TOB07LB12YeastCondition 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). 
Dataset2
RowSTUDYIDDOMAIN
LBSEQ
SPTOBID
LBGRPID
STOCONID
LBREFID
PTSEQ
LBSPID
PTTESTCD
LBTESTCD
PTTEST
LBTEST
PTORRES
LBTSTCND
PTORRESU
LBORRES
PTLLOD
LBORRESU
PTSTRESC
LBSTRESC
PTSTRESN
LBSTRESN
PTSTRESU
LBSTRESU
PTXFN
LBSPEC
PTNAM
LBSPCCND
PTSPEC
LBMETHOD
PTSPCCND
LBANMETH
PTLLOQ
LBTMTHSN
PTREPNUM
LBSTNRC
PTDTC
LBREPNUM
PTTPT
LBTPT
PTTPTNUM
LBTPTNUM
1TOB07
LB
PTSmokeless01Condition 1111
1
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
Smokeless01Condition 1112MOISTCTT
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
Smokeless01Condition 1113MOISTCTT
Product
Moisture
Condition 1 (X°C/ Z% RH)%%TOBACCO PRODUCTFRESH3
Content51.98%0.151.9851.98%TLT07_V1TPT LABCOTOBACCOAS-IS0.12302-01-2023Week 01
4TOB07
LB
PT
4
Smokeless01Condition 1114
Product MoistureCondition 1 (X°C/ Z% RH)%%TOBACCO PRODUCTFRESH1Week 8
MOISTCTTMoisture Content51.75%0.151.7551.75%TLT07_V1TPT LABCOTOBACCOAS-IS0.12103-29-2023Week 82
4
5TOB07
LB
PT
5
Smokeless01Condition 1115
Product MoistureCondition 1 (X°C/ Z% RH)%%TOBACCO PRODUCTFRESH
MOISTCTTMoisture Content51.75%0.151.7551.75%TLT07_V1TPT LABCOTOBACCOAS-IS0.12203-29-2023
2
Week 8
4
2
6TOB07
LB
PT
6
Smokeless01Condition 1
Product MoistureCondition 1 (X°C/ Z% RH)%%TOBACCO PRODUCTFRESH3Week 8
116MOISTCTTMoisture Content51.67%0.151.6751.67%TLT07_V1TPT LABCOTOBACCOAS-IS0.12303-29-2023Week 82
4
7TOB07
LB
PT
7
Smokeless01Condition 1117MOISTCTT
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
Smokeless01Condition 1118MOISTCTT
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
Smokeless01Condition 1119MOISTCTT
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
LB
PT
10
Smokeless01Condition 2120MOISTCTT
Product
Moisture
Condition 2 (A °C/ B %RH)
Content51.93%0.151.9351.93%TLT07_V1
TOBACCO PRODUCT
TPT LABCOTOBACCOAS-IS0.12
FRESH
102-01-2023Week 01
11TOB07
LB
PT
11
Smokeless01Condition 2
Product
121MOISTCTTMoisture
Content51.96
Condition 2 (A °C/ B %RH)
%0.151.9651.96%TLT07_V1TPT LABCOTOBACCO
PRODUCTFRESH
AS-IS0.12202-01-2023
2
Week 01
12TOB07
LB
PT
12
Smokeless01Condition 2122
Product
MOISTCTTMoisture
Content51.98
Condition 2 (A °C/ B %RH)
%0.151.9851.98%TLT07_V1
TOBACCO PRODUCT
TPT LABCOTOBACCOAS-IS0.12
FRESH
302-01-2023Week 01
13TOB07
LB
PT
13
Smokeless01Condition 2
Product
123MOISTCTTMoisture
Condition 2 (A °C/ B %RH)%%TOBACCO PRODUCTFRESH1Week 8
Content51.80%0.151.8051.80%TLT07_V1TPT LABCOTOBACCOAS-IS0.12103-29-2023Week 82
4
14TOB07
LB
PT
14
Smokeless01Condition 2124
Product
MOISTCTTMoisture
Condition 2 (A °C/ B %RH)%%TOBACCO PRODUCTFRESH
Content51.77%0.151.7751.77%TLT07_V1TPT LABCOTOBACCOAS-IS0.12203-29-2023
2
Week 8
4
2
15TOB07
LB
PT
15
Smokeless01Condition 2
Product
125MOISTCTTMoisture
Content51.84
Condition 2 (A °C/ B %RH)
%0.151.8451.84%TLT07_V1
TOBACCO PRODUCTFRESH
TPT LABCOTOBACCOAS-IS0.12303-29-2023
3
Week 8
4
2
16TOB07
LB
PT
16
Smokeless01Condition 2
Product
126MOISTCTTMoisture
Condition 2 (A °C/ B %RH)%%TOBACCO PRODUCTFRESH1Week 48
Content52.18%0.152.1852.18%TLT07_V1TPT LABCOTOBACCOAS-IS0.12107-19-2023Week 243
9
17TOB07
LB
PT
17
Smokeless01Condition 2
Product
127MOISTCTTMoisture
Content52.21
Condition 2 (A °C/ B %RH)
%0.152.2152.21%TLT07_V1TPT LABCOTOBACCO
PRODUCTFRESH
AS-IS0.122
Week 48
07-19-2023Week 243
9
18TOB07
LB
PT
18
Smokeless01Condition 2
Product
128MOISTCTTMoisture
Content51.87%0.151.8751.87%TLT07_V1TPT LABCOTOBACCOAS-IS0.12307-19-2023Week 243